1 FULL FINAL REPORT Increasing Community Pharmacy Involvement in the Prevention of Cardiovascular Disease Researchers: A/Prof Kay Stewart (Chief Investigator), Dr Johnson George, Dr Shane L Jackson, Prof Gregory M Peterson, Prof Jeffery D Hughes, Kevin P Mc Namara, A/Prof Michael J Bailey, Dr Arthur Hsueh, Jenny McDowell, Dr Luke Bereznicki, Peter Gee THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT FULL FINAL REPORT
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Increasing Community Pharmacy Involvement in the Prevention of Cardiovascular Disease
Researchers: A/Prof Kay Stewart (Chief Investigator), Dr Johnson George, Dr Shane L Jackson, Prof Gregory M Peterson, Prof Jeffery D Hughes, Kevin P Mc Namara, A/Prof Michael J Bailey, Dr Arthur Hsueh, Jenny McDowell, Dr Luke Bereznicki, Peter Gee
THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING
AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT
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Acknowledgements
We would like to acknowledge the excellent work throughout this project of Dr Rosalind Lau (Project Manager, Monash University), Dr Diana Bortoletto (Research Fellow, Monash University), Thomas Donovan (Project Officer, Monash University), Elsamaul Elhebir (Research Assistant, Curtin University of Technology), Angus Thompson (Project Officer, University of Tasmania) and Jill Finch (Research Assistant, University of Tasmania).
We are also grateful to:
• the pharmacists involved in the project for their commitment to the project
• the patients for their participation in the project
• the GPs for their involvement in the project
• the Project Advisory Panel for their valuable contributions at various stages of the project
Bill Kelly The Australian Association of Consultant Pharmacy
Paul Feldman Department of Health and Ageing
Toni Riley The Pharmacy Guild of Australia
Julianne Drewitt The Pharmacy Guild of Australia
Maxine Goodman Pharmaceutical Society of Australia
Mary Collins Australian General Practice Network
Vicky Cogley The National Heart Foundation
Sheila Rimmer Consumer Representative
• Alex Zhang, research assistant to Dr Arthur Hsueh, Centre for Health Policy, Programs and Economics, The University of Melbourne, for undertaking economic cost analysis associated with the project
• Professor Carol Morse (clinical psychologist, private practice, Victoria), Dr Lindsey Hyde (general practitioner, Reservoir Medical Group, Victoria), Laura Willis (clinical psychologist, Juvenile Justice, WA), Robyn Martin (cardiology clinical pharmacist, Hollywood Hospital, WA) and Leanne Basham (lecturer, School of Medicine, Deakin University, Victoria) for their valuable contributions to the comprehensive training of the pharmacists.
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This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report.
The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild.
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Acronyms
AQoL Assessment of Quality of Life
BP Blood pressure
BBQ Beliefs and Behaviour Questionnaire
CHD Coronary heart disease
CMI Consumer Medicine Information
CVD Cardiovascular disease
DAA Dose administration aid
ED Emergency department
EHRM European Health Risk Monitoring
EOI Expression of interest
GP General practitioner
HBPM Home blood pressure monitoring
HCG Hidden Control Group
HMR Home medicines review
ICER Incremental Cost Effectiveness Ratio
LYs Life-years
MPR Medication-possession ratio
MUR Medication use review
MONICA MONItoring of trends and determinants in CArdiovascular disease
NHMRC National health and Medicine Research Council
PBS Pharmaceutical Benefits Scheme
PCG Pharmacist Care Group
PhARIA Pharmacy Access/ Remoteness Index of Australia
QALYs Quality Adjusted Life Years
QoL Quality of life
RCT Randomised controlled trial
RPSGB Royal Pharmaceutical Society of Great Britain
TABS Tool for Adherence Behaviour Screening
UCG Usual Care Group
UMORE Unit for Medication Outcomes Research and Education
WTP Willingness to pay
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Glossary
antihypertensive blood pressure lowering
blood pressure the force of blood pressing against the walls of the blood vessels (arteries) delivering oxygen-rich blood from the heart to all parts of the body
cardiovascular disease any disorder affecting the ability of the heart or blood vessels to function normally
cardiovascular event a severe or acute condition relating to the heart or blood vessels, including the following: myocardial infarction, stroke, transient ischaemic attack, peripheral vascular disease, angina and congestive heart failure
co-morbidity the presence of one or more conditions (or diseases) in addition to a primary disease or disorder
coronary atherosclerosis thickening and loss of elasticity of the coronary arteries, leading to progressive insufficiency of the arteries (coronary heart disease)
coronary heart disease a condition of the heart caused by narrowing of the blood vessels that supply the heart muscle
diastolic BP the pressure in the arteries when the heart is at rest
heart failure inability of the heart to pump enough blood to sustain normal bodily functions
hypertension high blood pressure
medicines adherence the extent to which a person takes their medicine in accordance with agreed recommendations from a health professional
primary care essential healthcare made available in the community as the first contact in the medical management of a condition
stroke the sudden death of some brain cells due to a lack of oxygen when the blood flow to the brain is impaired by blockage or rupture of an artery to the brain
syncope a transient loss of consciousness and postural tone caused by diminished blood flow to the brain
systolic BP the pressure in the arteries when the heart contracts
unstable angina a form of pain that is prodromal to acute heart attack and typically has a sudden onset, sudden worsening, and stuttering recurrence over days and weeks
Table of contents .......................................................................................................................................................... 5
Changes to key parameters at three months (PCG group only) ................................................................... 45
Changes to key parameters at six months .................................................................................................... 45
Hidden Control Group .................................................................................................................................... 55
Results - Business Case evaluation ................................................................................................................... 67
Phase 4 Stakeholders Post-trial Focus Groups and Interviews ................................................................................ 71
Appendix 32: Phase 4 - Consumer Consent Form .................................................................................................. 198
Appendix 33: Phase 4 - Pharmacist Consent Form ................................................................................................ 200
Appendix 34: Phase 4 - General Practitioner Consent Form .................................................................................. 202
Logos ........................................................................................................................... Error! Bookmark not defined.
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Background
Hypertension in Australia
In 2004-2005, the prevalence of high blood pressure (known as hypertension) in Australia was 10%1. In 2003,
hypertension accounted for 7.6% of the total burden of disease in Australia2 and was responsible for the greatest
amount of burden in the 65 years or over age group in both males and females3.
Risk factors
The link between blood pressure control and health outcomes is clearly established. One of the key studies illustrating this is a meta-analysis of large-scale observational studies demonstrating a progressive positive correlation between increasing BP and death
4. Numerous clinical trials and meta-analyses have concluded that
antihypertensive medications substantially reduce the risk of CVD5,6
. For example, a reduction in systolic blood pressure of 12 to 13 mmHg over four years of follow-up can reduce heart attacks by 21%, strokes by 37%, and all deaths from coronary vascular disease by 25%
7. It is important to remember that the patient must actually take the
drug prescribed in order to receive the benefit, underscoring the threefold importance of screening, optimal prescribing and adherence/persistence with medication.
Nonadherence is the primary reason for suboptimal disease management8. In a major Australian study
9 comparing
self-reported antihypertensive medication adherence and cardiovascular disease outcomes, patients who were defined as being adherent to their medication regimen were 29% less likely to experience a fatal cardiovascular event or 42% less likely to experience a first occurrence of heart failure. Those 23% of patients who admitted to ever forgetting to take their medication were 28% more likely to experience a first cardiovascular event or death, whilst 11% of respondents who admitted to discontinuing medication had twice the risk of experiencing heart failure. In total, 33% of respondents were nonadherent in some way.
Persistence and adherence with antihypertensive medication
Barriers to medication adherence are numerous, and include the prescription of complex
medication regimens,
treatment of asymptomatic conditions, and convenience factors
10. Improving adherence
can be complex and
labour-intensive, and often needs to address individual patient circumstances11
. Thus, there are no accepted, fully
effective strategies in widespread clinical use.
Medication nonadherence is particularly problematic for asymptomatic conditions, such as hypertension and
hyperlipidemia, despite the favourable tolerability profile of many medications used in their treatment. An analysis of
21 phase IV antihypertensive medication trials12
found persistence after one year to be less than 50% (Figure 1), supporting findings in previous studies
13,14. Ten per cent of doses were omitted on any given day among those still
taking medications, with almost half of these stemming from ‘drug holidays’ of several days12
. It is important to note that day-to-day adherence with therapy and evidence of ‘drug holidays’ were predictors of persistence with medication use.
Figure 1: Persistence and adherence with antihypertensives12
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Taking multiple medications may further reduce adherence. In a retrospective study15
of 8406 patients who had
been initiated on treatment with prescribed medications for both hypertension and hyperlipidemia, the adherence
rate to both classes of medication decreased rapidly to 44.7% at the three-month interval, then
to 35.8% at six
months and thereafter stabilised. Choice of medication is also an important factor to take into account when adherence is being considered. Recent literature identifies differential levels of adherence for different drugs
16-21.
Figure 2 presents evidence of this in Australia.
Figure 2: Persistence curves for the three main classes of antihypertensive drugs20
The most important relationships between patients’ medication taking behaviour and patient characteristics (age, gender etc.) appear to be:
22,23
• physical and social vulnerability of the patient (e.g. being old, suffering a mental illness); and • failure in communication (largely due to differences in health beliefs of doctors and patients).
The need to improve adherence with antihypertensive medication
Medication adherence is a particularly important factor to consider in the management of hypertension. The majority of patients on antihypertensive medicines fail to achieve their recommended target BP
21,22. It is now clear
that poor adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target BP
23. Some experts even refer to these issues as two separate CVD risk factors.
Unfortunately, therapy discontinuation is common for conditions such as hypertension because patients experience no symptoms from the condition, but persistence with therapy may be associated with costs (e.g. attending appointments, side effects, paying for medicines). Success at a population level in controlling hypertension is largely the product of individual patient care by health practitioners, and evidence exists that a more rigorous, evidence-based approach to BP management is the key to achieving this
24.
The majority of patients taking medication for hypertension require more than one medicine to achieve their target BP
25. Therefore, the likely impact of adverse events and medication costs will be greater for this condition than for
many others. As well as elderly patients, young male patients are especially likely to be nonadherent with blood pressure medication
26. They are less concerned about the dangers of hypertension, less likely to practise lifestyle
modification, generally know less about blood pressure issues, and are more likely to stop taking medication without telling their doctor
26. Richardson et al
27 found that concerns about side effects were a major barrier to
adherence with antihypertensive therapy by the young and those newly initiated on therapy. This is more likely when the patient poorly understands the benefits of therapy. Potential nonadherence should always be investigated where there is failure to reach target blood pressure, resistant hypertension, or sudden loss of BP control. The counselling issues in Table 1 have been demonstrated to improve BP control, and highlight the importance of using behavioural modification techniques for all adherence interventions
28.
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Table 1: Effective patient counselling points for blood pressure
• Advise the patient of their blood pressure and give them a written copy of their reading
• Determine how well the patient understands their hypertension, explore any concerns they may have, and address misperceptions that arise
• Engage in patient-centred care that allows pharmacists to elicit and respond to key issues from the patient perspective
• Reach consensus with the patient about their target blood pressure
• Explain the recommended treatment
• Evaluate patient confidence with treatment and address any lack of confidence
• Emphasise and provide supporting information about the importance of lifestyle modification
• Emphasise the chronic nature of hypertension and its treatment, even when blood pressure is controlled
• Encourage the patient to propose any ideas they may have to modify their lifestyle.
Pharmacist promotion of adherence with blood pressure medication
As the medicines experts in the community, pharmacists are in an ideal position to address nonadherence and nonpersistence issues in people with hypertension. Pharmacists have proven their abilities in helping patients to achieve target BP
29. US guidelines advocate that doctors “must work with” other health professionals, including
pharmacists, to address issues surrounding medication adherence and persistence28
. A meta-analysis of 2246 patients in 13 studies, found that pharmacists’ interventions significantly (and substantially) reduced systolic and diastolic blood pressure. Improving adherence must be a core component of this role
30. In a US study of 200
community-dwelling elderly patients (92% drug-treated for hypertension) attending an Army Medical Centre, medication adherence increased from 61% to 97% following pharmacist intervention
31, and was associated with
improved cardiovascular outcomes. The intervention group also had significantly increased persistence at six months – 96% (intervention) vs. 69% (control). The community pharmacist is uniquely positioned in the Australian health care system to undertake a role in cardiovascular medication management, a role supported by public opinion
32. Leading Australian and international guidelines for BP management
31,33,34 recognise the widespread
detrimental impact of poor adherence and persistence with medications on BP control. When BP is uncontrolled, as previously stated, the patient is very unlikely to experience symptoms – unlike with conditions such as asthma or epilepsy
26. This can affect the priority given to adherence on the part of both the prescriber and the patient.
Doctors are more likely to accept therapeutic inertia and may be less likely to investigate or address nonadherence
28.
In designing an intervention involving pharmacists, it is essential to offer a complex range of strategies – adherence involves a complex set of issues for which homogenous simple interventions applied across the target group will not have an impact
35. Examples of strategies that can help appropriate patients with adherence to blood pressure
medication and other long-term treatments – as part of an overall strategy, not in isolation – include simplification of the medication regimen, motivational interviewing, label reminders to patients, information, counselling, reinforcement, family therapy, psychological therapy, mailed communications, manual telephone follow-up, and other forms of additional supervision or attention (e.g. electronic prompts, SMS reminders)
33-36. The importance of
motivating patients stems from a combination of issues that are relatively unique to BP treatment. The JNC-7 hypertension management guidelines
28 specifically state the need for health professionals such as pharmacists to
use motivational techniques to encourage patient adherence:
“Behavioral models suggest that the most effective therapy prescribed by the most careful clinician will control hypertension only if the patient is motivated to take the medication as directed and to establish and maintain a health-promoting lifestyle. Motivation improves when patients have positive experiences with, and trust in, their clinicians. Better communication improves outcomes; empathy builds trust and is a potent motivator”.
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Blood pressure self-monitoring is another option with significant potential37
. Other issues that can be addressed through existing pharmacy programs are medication profiling, home medication reviews and the use of dose administration aids. It is logical to integrate these existing options into new programs, not only to optimise impact for consumers but also to promote uptake by practitioners. A systematic review of interventions by community pharmacists to improve adherence to chronic medication use
38, noted that further research was required to identify
an overall successful adherence improving strategy performed by pharmacists.
Project Phases
This project had several phases. Phase 1 was a systematic review of published studies of cardiovascular healthcare services, with particular emphasis on those that feature strategies to improve BP control, mostly those focused on management of hypertension. Phase 2 comprised focus group discussions and interviews with stakeholders (consumers, community pharmacists and GPs) about aspects of adherence and adherence and persistence, particularly in relation to experience with antihypertensive medicines. The focus was on the desirable features of, and barriers and facilitators to, implementing a best practice adherence /persistence-enhancing service through Australian community pharmacies for people taking antihypertensive medicines. Phase 3 was a randomised controlled trial of a package of intervention strategies in a multi-state sample. Phase 4 comprised focus group discussions and interviews with stakeholders (consumers, community pharmacists and GPs) about their experiences with the intervention.
Phase 1
Systematic Review
Introduction
In order to inform the development of the interventions in Phase 3, a systematic review was undertaken of published studies describing cardiovascular disease programs, with a focus on those studies relevant to community pharmacy, the management of hypertension and adherence/persistence with antihypertensive medication. Meta analysis was considered inappropriate due to the lack of consistency in study methodology, study environment, patient groups and measures of adherence/persistence in the published studies that were identified.
Although many of the studies identified were randomised controlled trials, a lack of blinding and other methodological limitations meant that the overall quality of the evidence ranged from poor to fair. Previous related reviews
38,39 and meta-analyses
30,31,40 have drawn similar conclusions. Nonetheless, the review identified that a
significant number of relevant studies have been conducted and the findings of some of these helped to inform the proposed intervention in the HAPPY Trial. A large proportion of relevant research was from the US, with major contributions also from the United Kingdom and Canada. Despite differences in the healthcare systems between these countries and Australia, some of the findings were generalisable and applicable to community pharmacy practice in Australia. Although the review focused on hypertension, studies examining other chronic medical conditions which are related, either by the nature of the drugs used (e.g. heart failure), or by their asymptomatic nature (e.g. dyslipidaemia), were included in the review where they met inclusion criteria. A summary of the reviewed papers by disease state and the associated grade of evidence is provided below:
Summary of papers reviewed by therapeutic area and evidence grade
* The apparent number of papers exceeds the actual number reviewed as a consequence of numerous studies including patients with more than one disease state.
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Similarly, although priority was given to studies carried out in community pharmacy, those undertaken in other healthcare environments (e.g. hospital clinics) or by other healthcare professionals (e.g. nurses), were also included in the review where they met the inclusion criteria. A summary of the papers reviewed, showing the professional groups delivering the interventions and the associated grade of evidence is provided below:
Summary of papers reviewed by profession providing intervention and evidence grade
E1 E2 E3-1 E3-2 E3-3 E-4 Total Doctor 0 1 1 2 Nurse / care manager 2 2 4 Pharmacist - Community Pharmacist - Other pharmacist - Pharmacist-doctor collaboration
2 1 0
9 9 6
3 1 1
7 1 0
0 0 0
5 3 0
26 15 7
Review of all / other 2 2 0 1 1 4 10 Total 5 29 7 9 1 13 64
The search terms and criteria are provided in Appendix 1.
There are two consistent observations from the literature: • no single intervention to improve adherence with antihypertensives is consistently effective; and • no single intervention by community pharmacists to improve adherence with chronic medication is
consistently effective.
Those interventions for improving adherence with antihypertensives that have some evidence base are simplifying dosing regimens, motivational strategies, unit dose packaging, educational counselling by telephone, treatment in pharmacist- or nurse-operated clinics, mailed refill reminders, self-monitoring, fixed dose combination drugs, dose-tailoring, rewards, and combinations of the above strategies. Interventions by pharmacists for improving adherence that have some evidence base are counselling, monitoring and education during weekly or monthly appointments. However, it should be noted that some studies suggest that these interventions have no effect.
A previous review and meta-analysis has specifically looked at the sensitivity of patient outcomes to pharmacist interventions in hypertension
31. This concluded that systolic blood pressure was sensitive, but that diastolic blood
pressure, quality of life and adherence were nonsensitive. A common theme of the research and conclusion of some previous reviews
39,40 was the need for interventions to be tailored to the needs of the individual patient. In
addition, interventions that address multiple determinants of hypertension control are advocated41
. The interventions proposed for this trial would therefore appear to be appropriate, being supported by the available evidence and meeting the recommendations to be both multi-faceted and individualised.
Adverse effects
A noteworthy observation in one study was that adverse symptoms decreased as blood pressure became controlled with an increasing number of prescribed antihypertensives
42. This is a significant finding as fear of
adverse effects from antihypertensive medication may be a barrier to optimising blood pressure control in some patients. This evidence may usefully inform those discussions between pharmacists and patients that occur during the interventions proposed in the HAPPY Trial.
Baseline adherence levels
High levels of baseline adherence were found in two studies and these have been postulated as a potential reason why the respective studies failed to show significant impact. One of these studies
43 evaluated the impact of nurse-
led adherence support and reported no evidence of an effect. In the other study44
, the use of reminder (“beep”) cards was evaluated and, although this concluded that there was a possible positive impact on adherence, high baseline adherence levels may have been a factor in preventing this reaching significance.
The HAPPY Trial included only patients who had been screened as apparently already having poor persistence and/or adherence to antihypertensive therapy, or both.
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Multidisciplinary Team Efforts
A number of studies evaluated the impact of collaboration between pharmacists and physicians45-49
and pharmacists and nurses
50, with generally positive outcomes. Although these usefully add to the evidence base
supporting pharmacists’ role in hypertension management, these are often studies where changes to prescribed antihypertensive regimens occurred alongside other interventions, resulting in a lack of clarity regarding which specific interventions may have had an impact. Nonetheless, improved adherence is cited as a contributory factor to the benefits seen in some studies
45.
Although the HAPPY Trial is not formally collaborative with other health professionals, communication with general practitioners (GPs) will occur at several stages. These include provision of information regarding the study, requesting confirmation of primary hypertension in participants and information on their target BP. GPs will also be advised if a patient’s blood pressure is found to be significantly elevated and not controlled despite good adherence.
Cost-effectiveness
The cost-effectiveness of pharmacy interventions was evaluated in some studies51-54
. The additional workload for pharmacies had financial implications; however, when combined with reductions in costs elsewhere in the healthcare system, interventions were generally cost-effective. A health-economic assessment component has been built into the HAPPY Trial from the outset and will usefully inform the evidence base in this area.
Home blood pressure monitoring
Home blood pressure monitoring (HBPM) has been a component of a number of studies55,56
, some of which were pharmacy based
57-59. Whilst in general HBPM was considered to be beneficial, this is difficult to conclude reliably
given that it was provided as part of a multi-component intervention. The effect of HBPM on adherence to antihypertensives has been the subject of a systematic review
60 which concluded that the effects were mixed. Six
of 11 randomised controlled trials reported statistically significant improvements in adherence, but as with the pharmacy specific studies, most of these reported use of HBPM in combination with other interventions. This review found that trials in primary care settings reported negative findings; however, the authors concluded that future studies should take place in primary care as this is where the majority of hypertensive patients receive care.
While again using HBPM in combination with other strategies, the HAPPY Trial contributes to knowledge in the primary care setting.
Hypertension control
Most studies found that patients who had pharmacist involvement in their hypertension management or who received the intervention(s), had improvements in their blood pressure
48,50,57,59,61-68. Some of these trials, however,
used historic controls or failed to demonstrate changes in blood pressure which were statistically significant, thus undermining the quality of the evidence. In addition to reporting blood pressure changes, some studies reported data on patients’ achievement of target blood pressure
46, 58,69 and in some cases this reached statistical
significance compared to controls45,47,49,70
. Although evidence shows that any reduction in blood pressure is beneficial in terms of reducing the risk of adverse cardiovascular outcomes, these studies that show improved attainment of target blood pressure levels contribute most usefully to the evidence regarding the contribution pharmacists can make to hypertension management.
Other studies, however, have shown that interventions involving nurses or pharmacists have no43,71
, or at best a modest, impact on blood pressure
72. Patients with uncontrolled or resistant hypertension were the focus of a
number of studies46,58,59,62,73,74
and in these studies, beneficial effects of the pharmacy interventions were reported. Other studies, which recruited a broad range of hypertensive patients, showed the intervention only delivered significant improvements in blood pressure control in those who were previously uncontrolled
69. A further trial’s
findings led to the conclusion that the effectiveness of interventions may be improved by focusing on uncontrolled patients
72; however, another study specifically identified that interventions produce clinically important
improvements in blood pressure even amongst those who are relatively well controlled at baseline50
. Recognising the variation in the evidence base in this area, the HAPPY Trial recruited patients who appear to be nonadherent and/or nonpersistent with antihypertensives, irrespective of baseline levels of blood pressure control.
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Individual versus complex interventions
Many studies have applied a multi-faceted approach to improving persistence and/or blood pressure management and, where a benefit has been seen, it is often the case that the individual aspect, or aspects, which are responsible for that improvement are not identifiable. A common theme of the research, and concluded by some of the previous reviews
39,40 , is that interventions should be tailored to the needs of the individual. A “one size fits all”
approach will fail to impact on persistence rates for many patients, which reflects the diversity and complexity of the adherence-persistence issue. One study recommended that interventions affecting multiple determinants of hypertension control should be given priority over those designed only to increase medication adherence
41.
The proposed interventions in this study are multiple, including prescription refill reminders (delivered by telephone, SMS or mail at the patient’s discretion), disease and lifestyle advice, motivational interviewing, and home blood pressure monitoring; all with the support of a health professional who can tailor the emphasis to the needs identified from the initial discussion with the patient. The proposed interventions in the HAPPY Trial would therefore appear to be wholly appropriate, meeting the recommended need to be both multi-faceted and individualised.
Integration of treatment for hypertension with comorbidities
A number of studies have considered interventions in groups of patients with hypertension and other co-morbidities. In most cases these have been conditions where improving blood pressure control is an important component of the overall management of that condition e.g. diabetes
50,64,75; however, one study has assessed the
integration of hypertension management with treatment of depression and reported improvements in blood pressure and adherence
76. However, it should be noted that this one study was a pilot, with a small sample size
and short-term follow-up. It is proposed that, with the exception of patients with cognitive impairment, this study will neither preferentially select nor exclude those with other medical conditions and will thus assess the effectiveness of the interventions in the general hypertensive population.
Link between adherence and outcome
A number of studies have specifically looked at the relationship between adherence to antihypertensive medicines and both blood pressure control and clinical outcomes. One of these studies
77 reports that 43% of highly adherent
patients achieved blood pressure control compared to 33-34% of those who had low or medium levels of adherence. A retrospective cohort study of 3,998 patients with diabetes and ischemic heart disease
78 showed not
only lower mortality rates amongst adherent patients, but also that mortality rates do not differ between patients who are nonadherent and those not receiving any medication. Despite the evidence, recognising that sub-optimal adherence is a factor in poor blood pressure control and adverse outcomes has been described as a key challenge for those caring for patients with hypertension
79. Another study has looked at the link between nonadherence,
intensification of antihypertensive therapy and blood pressure control80
. This concluded that nonadherence can explain why blood pressure remains elevated despite intensification of treatment in some patients. There is, therefore, an established body of evidence on which pharmacists delivering interventions in this study can base their advice to patients regarding the impact of adherence and nonadherence.
Patient demographics
Few studies have evaluated the relationship between patients’ income and the effectiveness of interventions and, from the studies that have made an evaluation, the relationship is unclear. Evidence from one study suggests that intervention by pharmacists had an impact in those patients with higher incomes, whilst those with lower incomes appeared not to benefit
81; however, another study specifically recruited patients with low incomes and
demonstrated adherence improvements in this patient group82
. It should be recognised that these variable findings may reflect differences in health care provision for the poor in those countries where these studies were conducted.
The HAPPY Trial planned to recruit patients irrespective of their financial status, and to collect data on their income; therefore, any information obtained may usefully add to the evidence base in this area.
Some studies have looked at intervention amongst ethnic groups where there may be special factors, such as disease prevalence or impaired access to health services
47,59,75. From the limited evidence available, robust
conclusions cannot be drawn; however, it would appear that the benefits of increased pharmacist involvement in care may extend to these patient groups. In the HAPPY Trial, data relating to ethnic origin may usefully contribute to the evidence base in this area.
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Patient satisfaction with pharmacy services
Patient satisfaction52, 63, 65,69,83,84
was reported in some studies and, in general, patient satisfaction was high with interventions or hypertension management services provided by pharmacists. Given the political and professional drive to expand community pharmacists’ involvement in clinical services, it is reassuring that the evidence would appear to indicate patients’ support for this.
The HAPPY Trial planned to assess patient satisfaction with the interventions provided by their pharmacist, and the value service users place on this, by assessing their willingness to pay.
Persistence with antihypertensives
The literature contains many references to the poor level of persistence with antihypertensive therapy and the impact of this is recognised by various international guidelines. Of particular significance is a recent Australian study confirming the continued problem of poor persistence with antihypertensives in this country specifically
20,
which reported that, overall, 19% of patients fail to collect a second antihypertensive prescription and that median persistence time is only 20 months. This study, therefore, provides confirmation of the need to improve adherence to antihypertensives in the Australian population.
Pharmacists’ knowledge
One study has appraised pharmacists’ knowledge of hypertension and found this to be variable, frequently wrong, and suggested it should be improved with training programs
85. Although this study was conducted overseas, it is
important to recognise that Australian pharmacists’ baseline knowledge around hypertension and its management will inevitably vary. This re-inforces the need for adequate training of pharmacists prior to participation in hypertension studies, something which is recognised by the inclusion of a two-phase pharmacist training plan in the HAPPY Trial.
Quality of Life
Quality of life (QoL) has been evaluated by a number of studies, although in most cases the impact of interventions was modest
49,59,63,68,83 or variable related to patient income
86. The HAPPY Trial hoped to add to the evidence
available in this area, by including robust assessments of participants’ QoL.
SMS contact
Recent years have seen a number of studies87-89
, including some conducted in Australia90,91
, evaluating the role of mobile phone message reminders in healthcare environments. Review of these studies identified that none were conducted in community pharmacy or involved hypertension management. It is therefore impossible from the published studies, which considered outpatient and GP clinic attendance rates, to ascertain the role of SMS in medication adherence. The inclusion in the HAPPY Trial of SMS as one of the options for receipt of prescription-refill reminders cannot therefore be considered evidence based, but will usefully serve to evaluate this type of intervention in this setting. It will also recognise the need for interventions to be individualised to reflect patients’ own preferences.
Telephone contact
Telephone contact with hypertensive patients has been a component of a number of studies. In one study, educational and behavioural interventions to improve blood pressure control were provided by telephone calls, with a mean duration of 18 minutes, and showed some improvement in self-reported adherence assessed after six months
55. Telephone communication has been specifically used for prescription-refill reminders and was evaluated
in a recent study92
which found these to be no more effective than usual care at improving persistence. This lack of effect would appear to be a concern given that telephone reminders are one proposed intervention in the HAPPY Trial; however, there are important differences. Patients in this study had not been consulted prior to receiving the intervention and the pharmacies involved had been informed that they were required to participate. In the HAPPY Trial, patients have consented to participate, have the option to choose the method of receiving prescription-refill reminders (phone, SMS or mail) and pharmacy involvement is entirely voluntary. In addition, evidence from other research suggests that telephone-based pharmacy advisory services may have a role in improving adherence
93.
Consequently, the retention of telephone prescription-refill reminders as one option in this study would appear justifiable.
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Mail contact
Mailed medication-refill reminders were evaluated in one study51
and showed a significant beneficial impact on the medication-possession ratio (MPR), a surrogate measure of adherence, compared to usual care. The same study showed that the combination of mailed reminders and unit-of-use packaging produced a significantly greater effect than reminders alone. Use of mailed medication-refill reminders is on option in proposed the HAPPY Trial , alongside other interventions. Based on the literature, this appears entirely appropriate.
Therapeutic changes
In some studies, pharmacists’ interventions included making recommendations to prescribers regarding therapeutic changes
45-47,52,58,94 and in some cases modifying therapy themselves
48,49,84. In a number of these studies,
improvements in blood pressure were reported; however, it is impossible to identify if the improved control resulted from therapy changes or from the other interventions provided
58,95. The HAPPY Trial does not specifically involve
pharmacists making recommendations to prescribers regarding changes to patients’ hypertensive therapy. This reflects the current legal constraints in the Australian community pharmacy environment and, in particular, the fact that pharmacists do not have access to the patients’ full clinical records.
Time-related factors
The time taken to deliver the interventions was reported by a number of studies43,55,57,69,96
and this varied significantly depending on the nature of the intervention, ranging from around 8 to 60 minutes. It was also dependent on whether it was a first contact or a follow-up; where times for the latter were reported, these were significantly shorter. The evidence suggests that the time required to deliver the interventions is in line with what has been estimated for this study and with what has been discussed with practising Australian pharmacists. In one study
97, which showed improved medication re-initiation rates amongst those who received a multi-faceted
intervention from nurse care managers, the mean time to re-initiation was around 60 days. This suggests that patients may not respond quickly to the interventions they receive. Although the timelines for this study are fixed, this may have implications for the results obtained and may need to be considered for future studies of this type.
The frequency with which interventions were delivered or patients followed-up, varied between studies, but monthly 57,61,64,65,70,94,96,98-101
and two-monthly30,33,45,69,102
contacts were most common.
The HAPPY Trial includes follow-up appointments at three-monthly intervals, which is less frequent than many of the currently published studies. Originally two-monthly follow-up was planned (requiring one extra appointment); however, this was changed following discussion with the Advisory Panel, who had concerns about the associated workload and, hence, the cost for the pharmacists.
Evidence also exists from some research that the effect of pharmacy interventions dissipates when the research ceases and continued interventions may therefore be necessary to maintain the benefits
66,82,94. The level to which
any impact of this study’s interventions are sustained cannot be assessed due to the fixed timelines. However, this is an important issue, as although any improvement in persistence and/or blood pressure control is desirable, the significance of this in terms of clinical outcomes is dependent on it being sustained long-term. Consequently, consideration may need to be given to the design of an appropriate follow-on study to evaluate this.
Web-based communication
One recent study included internet-based communication with hypertensive patients as one component of a more complex intervention strategy
56 that included utilities such as access to a health library providing resources for
lifestyle and behavioural changes, prescription refills and secure e-mail for communication with healthcare professionals. In that study, those patients who received intervention from pharmacists via web communication showed improved blood pressure control compared to those in comparator groups who had access to the web utilities without pharmacist involvement. No robust conclusions can be drawn regarding the value of web communications in aiding hypertension control given the limited evidence available and hence not utilised in this study.
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Phase 2 Stakeholders Focus Groups and Interviews
Aim
The aim of this study was to identify and qualify the barriers and facilitators to the implementation of a blood pressure (BP) medication adherence service in Australian community pharmacies.
Methods
Focus groups and interviews were conducted with three groups of stakeholders: consumers, community pharmacists and general practitioners (GPs). Each participant was given an explanatory statement (Appendices 2-4). Each group was convened as a separate focus group. Individuals who wished to participate but were unable to attend the focus groups were interviewed by telephone.
Inclusion criteria
Any registered and currently practising pharmacist or GP was eligible to participate in this study. Any adult consumer taking at least one blood pressure medication was eligible to participate.
Recruitment
Community pharmacists, GPs and consumers were recruited by convenience sampling.
Procedure
Focus groups were moderated by Assoc Prof Kay Stewart. Telephone interviews were conducted by Dr Diana Bortoletto and Assoc Prof Kay Stewart.
Focus groups and telephone interviews were audiotaped and transcribed verbatim, where possible. Supplementary notes were also taken by an observer present at the focus groups and interviews.
A topic guide (previously reviewed by the project Advisory Committee) was used for all focus groups and interviews (Appendix 5). The guide was designed to start with the broad topic of perceived issues to do with adherence, particularly with antihypertensive medications, and how and with the help of whom they may be overcome. The conversations then moved on to focus on community pharmacies and the barriers and facilitators to implementing a pharmacist-driven adherence program for patients taking antihypertensive medicines.
Ethics
This study was approved by the Monash University Human Research Ethics Committee. Written informed consent (Appendices 6-8) was obtained from each participant prior to interview or focus group participation.
Results
Participants
Eight pharmacists attended their focus group and one pharmacist was interviewed by telephone. Two pharmacists worked in independent pharmacies, five pharmacists worked in larger pharmacies operating under pharmacy banners and two pharmacists were Professional Service Managers for banner group pharmacies. Three GPs attended their focus group, while three GPs requested telephone interviews. Ten consumers attended their respective focus group.
The gender distribution of all participants is shown in Table 2.
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Table 2: Gender distribution of stakeholder groups
Male (N) Female (N) Total (N)
Pharmacists 4 5 9
General Practitioners 5 1 6
Consumers 6 4 10
The main themes identified from the focus groups and interviews are listed below. Comments or quotes from participants or observer notes are given as evidence for the emergent themes. Pharmacists’ quotes can be identified by the prefix letter ‘P’, consumers’ by ‘C’ and general practitioners’ by ‘GP’. These letters with participation number are shown either at the beginning or end of each quote.
Themes
1. Issues around medication nonadherence
Patient medication adherence was perceived to be a problem by all three stakeholder groups. All agreed that there are certain issues which affect consumers’ regular medication taking.
Pharmacists thought polypharmacy increased adherence, because it serves to establish a ‘medication routine’.
“If I’m thinking of people who are nonadherent with their blood pressure medication, I’m thinking that there’s essentially a group of people who are on multiple medications – and they’re probably more likely to be adherent.” P7
However, GPs thought that it would be a cause for nonadherence.
“I agree that taking medications is often a problem for some people, particularly if they are on a number of medications.” GP4
The consumer group corroborated that complex regimens are more likely to be forgotten, especially night-time doses and when going out for the night.
Pharmacists believed that elderly consumers were likely to be more adherent, and this theory was supported by the consumer group who were surprised to hear that a large proportion of people are nonadherent with their medications. Consumers described established routines to remind them to take medications.
To overcome adherence problems either due to polypharmacy or multiple dosing, all three stakeholder groups thought that physical aids such as Dosage Administration Aids (e.g. Dosettes, Webster packs) would help.
“I find particular things like Webster pack, especially if they are on a number of medications, are very good.” GP4
“I find if a doctor recommends a Dosette then we find improved adherence.” P6
C1: Uses a Dosette to help with his medication taking. (Observer notes)
Consumers raised the issue of confusion in timing of having prescriptions dispensed, as different medication packs contain differing numbers of tablets; hence, they may run out of one medication earlier than another, possibly leaving no continued medication supply or repeat prescription. Pharmacists suggested that a positive aid to improving adherence may also be sending patients SMS message reminders to get repeats dispensed.
“…I was part of a [drug company focus] group like this and they tested on consumers, SMSing when their next box was due, and that seemed to go down very well with consumers in terms of improving adherence.” P6
“We’re actually doing that [SMS messaging] in our pharmacies, and yeah it’s really, well it’s good from a business point of view, but it is actually getting some really good results.” P8
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Consumers liked the idea of being sent reminders to fill scripts; however, they expressed the opinion that these should be offered rather than insisted upon.
C10: If a reminder was offered, rather than enforced, it would not be intrusive. (Observer notes)
Other commonly named barriers to adherence included adverse effects, medication cost and cultural barriers.
All three stakeholder groups considered consumer education to be a significant factor to help overcome adherence barriers such as denial of having hypertension, lack of disease knowledge, and the lack of immediate reward for taking medication, especially in the case of a largely symptomless condition like hypertension.
2. Consumer education
The consumer group believed that it is very important to educate patients on the consequences of nonpersistence and nonadherence with medication. This had already changed one consumer’s habits, as fear of a possible stroke due to uncontrolled blood pressure had encouraged her adherence.
C9: Fear of having a stroke encourages her to take her medication.
: Would prefer not to take the medication, but understands the need. (Observer Notes)
The pharmacist and GP groups thought that the most important thing to convey to consumers was information about the disease state, blood pressure control and the effects of poor adherence. Consumers need to understand why they are taking medications, and that they may not necessarily feel better in the short term, but that medications are used to reduce the potential for developing more serious health problems.
“We don’t give them medications to make the pharmaceutical companies rich; we give them medications where we believe this is going to prevent some incident in the future. … And somehow we’ve got to get that information across to our patients …” GP3
Patients need to understand the benefits of continued blood pressure control. Pharmacists and GPs emphasised that the definition of ‘long-term treatment’ needs clarification with patients and that regular education reinforcement is important to reduce complacency.
“So, the information on the disease state and so on is really, really helpful for … just presenting an argument to convince people why it’s so important.” P6
Pharmacists suggested that regular shorter educational sessions may be more effective than a once-off longer session.
P9: Feedback from consumers is that HMR often just deals with suitability of medicines and not other issues. Once a week follow-up would be better, e.g. for three months, rather than have a chat for one hour and then nothing! (Observer Notes)
“You need to stay on top of it because as time goes on they forget and they just, they’re involved in their everyday lives. It doesn’t take priority for them and just slowly sort of dwindles away. So I think it’s not just your first one, it’s your follow ups, six monthly, yearly, whatever it is, because the message isn’t just going to sort of hit, stick the first time.” P3
Regular patient reviews were also considered important by the GPs, especially when newly diagnosed.
“… patients that I have, like for instance, just started on an antihypertensive, I’ll get them to come back, and I’ll review them. And I’ll keep doing that until their blood pressure is under control.” GP5
Further, it was thought that education needs to be individually tailored. A person on multiple medications may experience information overload, with any further education having little benefit.
“It’s more that I think the level of information has to be tailored to the person…” P8
“Perhaps the younger people would be best to put with information about disease state …, so along [with] the CMI (Consumer Medicine Information) would be information on how blood pressure affects you for the next 5, 10, 20 years. And those people who are already taking multiple medications, it’s probably not going to be as beneficial perhaps to them, because they’re already taking information overload. Maybe they would be more the people that you’ll be pushing more for HMR and that sort of thing, because that reinforces adherence.” P7
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Doctors also mentioned that language is very important. A lay person may not understand medical jargon or the importance of percentages being used to illustrate a possible health outcome. A patient may not necessarily understand the relevance of these figures to their own health.
“I deal with a lot of migrants and unless you've got a certain level of education, statistics don’t mean very much. People have that concept of statistics stated to them ‘You know, you’ve got a 20% [risk]’, it doesn't mean very much. So we’ve got to look at ways of getting that information to our patients, … why we’re giving them medication.” GP3
Some GPs thought that pharmacists are well educated in conveying information in lay language.
“And especially since they [pharmacists] normally counsel patients on a day-to-day basis, and they can talk to them in so-called lay language, which is very easy to understand.” GP5
It was suggested that realistically, pharmacists, due to their other daily work, often have less than five minutes to counsel a patient.
In general, pharmacists’ assumption was that the more education patients receive the better they will adhere to their antihypertensive medications.
“I think regardless of who it is, the more information that person has about their disease state and why they’re taking the medication, the more likely they’re going to take it.” P8
However, it is important to recognise that not all patients want education. One consumer felt that the directions on the dispensing label were sufficient information.
C3: The dosage instruction on the label is all that is needed. (Observer Notes)
Changes in lifestyle, such as diet, weight reduction and exercise, would also need to be incorporated into consumer education. Diet, together with medication, was recognised as being important to blood pressure control by some consumers.
Pharmacists believed that the process of adherence, not only to medication but also to these lifestyle changes, may be too difficult for some patients.
“Yeah, I think a lot of people see it as a weakness, that it’s something that they should be able to control. But having said that, they either don’t know or aren’t prepared to make the changes. Like the 50 year-old man who smokes, who has [high] blood pressure and he says ‘Oh, but I'm fairly fit’ Like ‘I don’t really have it’ or ‘I don’t need this’, and yet you can say ‘Well, for a start, stop smoking.’, ‘Oh I can’t do that, oh no, that’s too hard, oh no!’.” P2
3. Health professionals’ roles in assisting adherence
General practitioners and pharmacists were identified by all groups as the main health professionals who play a role in ensuring medication adherence by patients.
“I think it’s both the GP and the pharmacist. If there’s appropriate time devoted in the pharmacy then I think that has a huge impact.” P8
“I think everybody has got to be on board. If they hear the same message from everybody, then they are more likely to adhere to it. GPs and pharmacists I think would be the two main people who would be involved in it.” GP4
a. General practitioners
Consumer group participants felt they had great relationships with their GPs and if they had queries about their health or medications would make an appointment with their GP. They felt that the doctor knows their health best, as they have their history at hand during the consultation.
C6: Has a good relationship with the GP and knows that the GP has all his personal information on his computer in front of him. (Observer Notes)
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While most had no difficulty getting an appointment at short notice with their GP or another GP within the same clinic, a couple of consumers mentioned that this was not the case for them, which meant that any immediate queries regarding health or medication would not be addressed.
C8 and C6: Have difficulty getting appointment to see the GP to discuss health matters. (Observer Notes)
b. Pharmacists
Some consumers had great faith in their pharmacist. They were supplied with lots of information by the pharmacist and had a great relationship with them.
C1: Is happy with his pharmacy. Is offered information with new medication as well as a CMI.
C10: Has a level of trust with the pharmacist.
(Observer Notes)
However, it was suggested that some pharmacists communicate better than others. While some are very clear with their education and supply written information, other pharmacists do not seem to like customer contact and are therefore quite reluctant to counsel. Consumers expressed concerns that approaching a pharmacist who did not like to counsel may result in an unsatisfactory level of advice. One consumer experienced both types of pharmacist in his local pharmacy.
C10: At his regular pharmacy there are two pharmacists; one of these pharmacists is lucid in his explanation of any medication problems. The second pharmacist doesn’t like customer contact and rarely comes out of the dispensary. As such, there is no information provided by this pharmacist.
(Observer Notes)
The pharmacist participants were aware that some pharmacists had difficulties communicating with patients.
“I know some of our pharmacists have trouble with – particularly pharmacists that have always just stood behind the computer and never come out – the actual translation of what’s in the book to what they're going to say is difficult.” P8
Even though some consumers had a good relationship with their pharmacist, they sometimes felt uncomfortable approaching them for further information, preferring their GP as the more appropriate source of information.
C7: Would like to receive information from the pharmacy, but doesn’t know what to ask.
(Observer Notes)
Consumers were concerned that the lack of privacy in a pharmacy made them uncomfortable to talk about their health.
C9: Large counters at some pharmacies mean that there sometimes are four people at the counter at the same time.
(Observer Notes)
Pharmacies, in many cases, were thought to lack a private consulting area. This issue was also raised by the GPs.
“I suppose the difficulty is whether each pharmacy has the infrastructure to have, like a little cubicle, or a separate counter where the pharmacist could actually counsel the patient in private.” GP5
c. Challenges to adherence management by health professionals
Pharmacists and doctors thought that, while they are well placed to determine a consumer’s adherence to their medication, there are a number of barriers. Pharmacists can check in their records how regularly a patient’s medication is dispensed, but they were aware that consumers may shop at other pharmacies and that, following a GP consultation, the dosing regimen may have changed.
“And you have the problem that they can go to different stores so you don’t know if they're going to come back – or whether they have taken it.” P1
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Pharmacists also admitted that, at times when they are too busy, they find it difficult to check the previous dispensing date to assess a patient’s medication adherence.
“You know what, you're doing 180 scripts before 12 o’clock, you're not going to sit there looking at the difference between, you know it’s within a month, yeah, but you don’t know the 4 or 5 days .. ” P3
Reliability of self-reporting was one of the barriers both doctors and pharmacists mentioned. If it appears that a patient is nonadherent with their medication, pharmacists and GPs recognised that patients often state that they have taken all their medications as instructed, have not had them dispensed at another pharmacy or received another prescription elsewhere; yet the health professionals are aware that the patient would have had insufficient medications or repeat prescriptions to cover the time since last presentation to the pharmacy or surgery.
Pharmacists thought that perhaps some patients feel they may get into trouble if they admit to nonadherence, and will give the answer that they believe the health professional wants to hear, whereas perhaps other patients may be unable to admit to themselves that they are nonadherent.
“They know they're not taking it but they’ll tell you they are, when you know damn well that they're not, because they think that’s the answer that you want to hear.” P2
Pharmacists felt a conflict of interest, not wanting to take on the role of the medication police, which may come across as being too aggressive to patients.
“I don’t want to go out and be the policeman who says ‘I can see that you're not taking your tablets, I don’t care what you say, this shows me that you're not’. And they're likely to go ‘Well fine. I’m not coming back to you then’. You have to handle that side of it really well; you can’t be showing them that they're wrong.” P2
d. Team approach to adherence
GPs and pharmacists both suggested that, ultimately, the two professions have similar goals in improving patient medication adherence and blood pressure control. Ideally, they should work as a team, especially those GPs and pharmacists who sincerely want to make a difference to their patients’ health.
“I do think we all have the same goal. We would like our patients to have a better blood pressure control and I think we all would like to improve the adherence. I think I would like that and I think I’m sure the pharmacist would want that.” GP3
Currently, as GPs suggested, there seems to be little communication between the two health professions, each working in isolation rather than as a team.
“The fact is, the opportunity is there – because at the moment I don't think we work as a team at all. I think we work in isolation: I work in isolation, the pharmacist works in isolation.” GP3
Lack of time to pick up the phone was cited as a reason for lack of communication between GPs and pharmacists, especially as phone calls could be inconvenient e.g. during a consultation.
“A phone call is difficult, because it always happens at the most inopportune time and it’s very hard for the pharmacist to know when it is an opportune time, or for me to know when it’s an opportune time. …Like today I was absolutely flat out. I’m not going to stop to pick up the phone and ring the pharmacist and say beware of this patient.” GP3
GPs believed that pharmacists within the large pharmacy chains seem less approachable and such pharmacists were often unknown to them.
GPs thought that in today’s electronic society, it should be possible to link patient information between doctors and pharmacies. Electronic means were considered to be the most effective form of communication; however, due to privacy laws, this form of contact is impossible.
“And before, you could fax things and they went to the wrong place and nobody worried about confidentiality. Suddenly, when we’ve got the tools to be able to communicate, we’re making life impossible for ourselves – we being the government, or whatever. I mean the fact that they go to different pharmacists should make no difference to be able to check whether they’ve been somewhere
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else. Those computers should be linked. The fact that they’ve been to another doctor, I should be able to check whether they’ve actually been, and the reality is we can’t.” GP3
For the pharmacist and GPs to work as a team, GPs believed it was important for patient education to contain consistent information.
3. A pharmacy service for improving adherence
a. Perceived benefits
Some GPs were immediately supportive towards a pharmacy service for improving adherence. They thought that pharmacists had the knowledge to implement an educational service to patients. Further, these GPs saw it as beneficial for patients to have the importance of medication adherence reinforced between visits to their doctors.
“I think they are probably quite well qualified in the medication side of things, they’re very well qualified. They specialise in pharmacy, they know a lot more of the drug end of things. Certainly having that one-on-one service, that might be good so that they could have frequent visits. They could keep a good, like an update, a monitoring of the blood pressure. And yeah, it would probably have a good result that way as well.” GP5
“There are some things that are appealing because that means that at least the patients are getting … they’re made aware that it is important to follow up and take their medication and monitor their BP.” GP4
Pharmacists agreed with the suggestion put to them that the convenience of the community pharmacy and the need for patients to visit the pharmacy more frequently than the doctor’s surgery make it the ideal setting for such a service. Consumers agreed that the community pharmacist was well positioned.
C7: This could be a good idea.
: Pharmacy is based within the community with regular customers with a regular GP.
(Observer notes)
Some consumers believed that a formal service would serve as a good reminder of any information previously received on new medications or as a good back-up to reinforce GP-supplied information.
C6: Will get information with medication when initially prescribed, but over time will forget.
: Would benefit from being reminded from time to time.
C10: Would like to back up information provided from the GP.
(Observer Notes)
b. Perceived barriers
A few GPs were initially displeased with suggestions of a formalised pharmacy service to improve medication adherence. One GP thought that pharmacists currently play a minor role in ensuring adherence or monitoring blood pressure. This kind of service was deemed by some to have little benefit to the patient and would only serve to antagonise doctors by interfering with their clinical practice.
GP6: Annoying as a GP to have a pharmacist refer patients; pharmacists want to be doctors. This type of work shifts into GP territory, it’s a GP thing. Pharmacists would be taking over and interfering with clinical practice, but not helping.
(Observer Notes)
One GP, while in favour of pharmacies providing an adherence program, raised the point that as a result of a pharmacy service, patients may have less frequent GP appointments than usual, , which may impact on other health issues unrelated to BP being missed.
“My slight concern would be that, normally when we see somebody, it’s not just their blood pressure that we are checking. Sometimes it’s hard enough to get some people to come back anyway. So
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getting their script is sometimes what we’ve got to get them in the door. But we use that as an opportunity to check their general health as well.” GP4
Consumers shopping at different pharmacies was also thought to hinder pharmacists’ ability to address adherence.
“I suppose it is the same as going to one doctor, to get them to go to one pharmacy is much better than shopping around pharmacies, like shopping around doctors.” GP4
The GPs also were concerned that patient types interested in attending a pharmacy adherence service may be those already adherent with their medications. Nonadherent patients were thought to be less likely to want their blood pressure checked regularly.
“The people that will do it are probably the ones that are already going to be adherent, and the people that are less likely to are likely to be itinerant, and less likely to do it. So I am not sure how useful that would be.” GP4
Some consumers suggested that unless a trigger or problem occurred, such as increased BP or feeling unwell, they would be disinterested in increasing their disease knowledge and therefore would not attend a formal pharmacy service.
C10: Isn’t aware of his blood pressure.
: Would need a trigger to increase knowledge of how his blood pressure is to make a difference to his adherence with medication regimen.
(Observer notes)
While some thought that the pharmacist is well positioned within the community to provide such a program, and that it would improve loyalty, others would rather see their GP regarding any health concerns.
C5: Would go to GP if they had any concerns with their health or medication.
(Observer Notes)
Consumers felt that a program would work only if the patient had confidence in the pharmacist and their ability to deal with issues accurately.
C10: Would need to have confidence in the health professional telling them about blood pressure.
(Observer Notes)
Time availability
Pharmacists were concerned about the time required to deliver the service; this was intimately linked to having sufficient staff available and the cost of employing staff. It was acknowledged that adoption of any program would be dependent on pharmacist staffing levels; smaller pharmacies with fewer pharmacists were thought to be likely to struggle to implement a program.
“It’s really hard even just finding the time, and I’ve been involved with Kevin’s Healthy Hearts project [a Guild project run out of the Department of Pharmacy Practice, Monash University] and it’s, we only have one pharmacist on duty, and it’s meant that I actually have to come in on my days off, especially to do the first interview, I’ve had to come in on my day off.” P2
c. Potential facilitators
Simplicity
The pharmacist focus group suggested that, above all, any program would have to be simple for both pharmacists and consumers to use.
“Things have to be super simple for people to get involved … Unless it’s a simple, really easy to understand, easy to explain and easy to sell kind of product, I don’t think it’s going to fly.” P8
“I think really it needs to be user friendly so that a lot of people can do it - even if one person really likes doing it - but that everybody is able to do it.” P7
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Blood pressure monitors
It was suggested by pharmacists that using blood pressure monitoring as part of a larger, formalised consumer education package may have a greater impact on adherence and may increase consumers’ uptake of such a program. Regular BP monitoring was thought likely to jolt consumers into action, especially if their BP is generally borderline or high. Pharmacies were seen by GPs to be in the prime position to help blood pressure monitoring, either by providing the facility to check blood pressure within the pharmacy or by selling home monitors to the public.
“Because the blood pressure measurements aren’t that difficult. It’s not like it is a hard process, and given that the community pharmacies can sometimes be more accessible than going to the doctors. You have to make an appointment, and depending on whether the clinic charges a fee, like a private fee to be seen, then they might be out of pocket; whereas if you could introduce something like that in a pharmacy, then they will eliminate that factor. Might be good.” GP5
Pharmacists believed that a free blood pressure monitoring service within the pharmacy would be beneficial to improve adherence. Properly trained staff could check the blood pressure and consult the pharmacist about high readings.
“We offer a free blood pressure monitoring. They’ll often have a little table and chair and we get the patient to go and sit over [there] for about 10 to 15 minutes, which gives us some more time and then we send a senior scheduled staff member, and they’ll go over and measure the blood pressure. And then, if it comes up that it’s a little bit high, they’ll come and check with us, and we’ll go out. I know it very quickly weeds out [those who] haven’t been taking it for a little while or the doctor’s adjusted their dose or they’ve adjusted their dose or something like that So we just advertise that that’s a free service and often that’s one way we can help them.” P6
There were concerns from GPs about pharmacists providing BP spot checks, because the consumer may come to the pharmacy in the middle of a busy shopping day and therefore their blood pressure may be higher than at relaxed state due to being rushed.
“Normally when they come into us, most doctors are running late anyway. But if somebody is to come up to the counter in a pharmacy, and they haven’t sat down, had a good rest for a while, it’s not necessarily going to be an accurate reflection of their blood pressure.” GP4
Some GPs were more inclined to favour home blood pressure monitors for the patient and it was suggested that a formal pharmacy program should provide patients with blood pressure monitors to record their blood pressure at home.
“…one of the things that seems to sort of jolt patients is when they have an ambulatory [BP monitoring test]. Especially a lot of people have the 150, the borderline blood pressure, and if a wife or a partner takes them and they see that 170, they really do get a bit scared.” GP1
Consumers stated that they would be willing to make use of blood pressure measuring services provided by pharmacies between GP appointments.
C10: Has his next GP check-up in May, but would use a BP monitoring service within that time if one was available.
(Observer Notes)
Teamwork between pharmacists and GPs
Ideally, GPs suggested that there should be a formalised agreement between the GP, pharmacist and patient. Teamwork was again mentioned as being important to make it work.
“I wonder whether, if it was going to be done, there was some sort of initial agreement between the pharmacy and the doctor and the patient at the beginning. So there was some sort of formalised agreement.” GP4
GPs stated that they would like to be notified of any patient issues arising from the service at least every six months, to coincide with patient’s next GP appointment.
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“And I suppose that’s what would improve with our adherence with our patients is, if somehow the pharmacists, you’ve picked up the same kind of things that I’m picking up, if they communicated that to me somehow. But it’s got to be an easy communication.” GP3
“So that would fit the six-monthly rhythm as well for those where the doctors need to see them, I guess.” GP1
Any information (not just BP readings) which gives insight into possible adherence problems was considered useful. The preferred method was paperless communication of this information. Uploading it electronically into the GP’s history manager would be ideal, although an email which may be cut and pasted would also be suitable.
“Ideally for us it would be an encrypted email. Because we have got computerised records and anything that comes on paper we have got to scan it in. But if it is already in an email then we can just look at it and send it straight to the patient [history]. So that is more convenient to us.” GP4
However, privacy issues were raised. The patient’s trust and confidence in the pharmacist may be reduced if consumer consent to sharing information is not first sought. The patient–pharmacist relationship was considered to be as important as the patient–GP relationship.
“I suppose, just as there is a doctor–patient relationship, there is also a pharmacist–patient relationship. And I suppose, if the patient was happy for that information to be divulged to the GP, then there would be, as a courtesy, they could give a GP a phone call maybe. Or advise the patient to let the GP know; but on the other hand if the patient didn’t want that information to be divulged, then I couldn’t see that the pharmacist could go and inform the GP, because that would then be against their confidence or trust.” GP5
While all three stakeholder groups suggested that some GPs may feel that pharmacists would be treading on doctors’ toes, the GPs in the focus group thought that doctors need to learn to cope with their insecurities and pharmacists will have to be aware of GP expectations.
“And sometimes, okay, some doctors might feel again that somebody else is treading on their toes. Okay, fine – get them sent back to those doctors. … I see it as a partnership; I don’t see it as competitive.” GP3
As long as the pharmacist works within the boundaries of their capabilities and refers patients when needed, GPs did not feel that pharmacists were encroaching on their professional turf.
“And certainly, I suppose, as long as they [pharmacists] know at which point it would be appropriate to refer on, then I think that would be really good for patients.” GP5
Training of pharmacists
According to the pharmacist group, successful implementation of an adherence service in community pharmacies will require pharmacists to be competent with communication skills. The pharmacist group believed that many pharmacists would require further training in this area. It was suggested that general statements or questions could be given to pharmacists to use as a lead-in to a conversation and result in a positive patient response. Communication skills go beyond counselling; one pharmacist suggested that many need to learn to “sell” good health and adherence to the patient.
“If you want a product to put across the whole group, it might be training for all pharmacists in how to sell properly. And when I say ‘sell’ I don’t mean flogging stuff, I mean how do you sell to someone the idea of taking their medication? ... I think if you gave them appropriate training on this is how you do it, and these are the sentences you can use to do that, then I think they would. I think it’d be terrific. But I just don’t think some of them have the words in them, they don’t know how to tailor the advice.” P8
“We can’t just blurt them out, because a lot of things in pharmacy, we just tend to blurt out and just leave them on the table and see what sticks. But if there's some success to it, you actually need to back it up with some training. So when you roll these things out, if you want to participate, everyone undergoes this sort of training.” P3
Pharmacists preferred face-to-face training sessions rather than online training. They felt online training would provide insufficient interaction with other people and observed that at the end of online training it may be easier to fabricate assessment answers without having undertaken the required prior reading.
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“If you're going to participate then there's got to be some formal training, not online training, something where you guys sit down for a couple of hours and you might get taught to counsel again. And it can’t be online, so then someone else can do it, or it’s A B C. It can’t!” P3
Sole pharmacist participation
Pharmacists also thought that independent pharmacies would benefit from the introduction of an externally established service program (e.g. supported by a national pharmacy body), as it would be difficult for them to establish their own program. In addition, these pharmacies do not have the same access to educational programs, such as some of the larger affiliations provide to their pharmacies.
“You guys that have got individual pharmacies, there's no – why would you bother – if you don’t have the time to organise, as we were saying, a specific module to go into the pharmacy, ‘This is your wound care program, you can now sell it to patients.’ You don’t have the time for that, whereas you’ve got to have something prepackaged that you can then set up a production line essentially, and do them instead of doing scripts.” P8
Remuneration
All three stakeholder groups agreed that pharmacies should be remunerated for delivering any patient adherence program.
Those GPs who supported a pharmacy service thought it would be important for pharmacists to be paid for their efforts and that it would be unlikely that any substantial service could be successfully provided by pharmacists without financial compensation.
“I think it’s very important that pharmacists get paid for performance benefit, they're getting rewarded for this kind of thing. Because pharmacists will not do this if they're not financially remunerated or rewarded for it. Similar issue with GPs and care plans, I guess.” GP1
Several potential avenues for payment were suggested, including drug companies, patients and government.
GPs thought that drug companies could sponsor blood pressure monitors and also provide other financial help with a adherence program.
“…I have absolutely no difficulty getting any one of the drug companies … we can get them [blood pressure monitors] no worries. They're knocking on our bloody door every time. Why not use the pharmacy and run ambulatory monitoring for them?” GP2
“And maybe that’s another thing we’re missing – that people with a bucket load of money is the pharmaceutical industry and they have a huge responsibility maybe to spend some of that money in chasing up some patients and doing all that other stuff.” GP3
Pharmacists suggested drug companies pay for SMS reminders, as, ultimately, they would benefit financially if a patient is adherent to their product.
“…I don’t think it should be us SMSing them … at our cost. I think it should be the [drug] companies that are making it. It’s their responsibility to push adherence.” P4
Pharmacists thought that patients would probably be unwilling to pay for additional services as they are not used to doing so in the pharmacy setting. It was thought that consumers may be less likely to pay for a service around hypertension as there are no obvious physical signs with high blood pressure and therefore they may not perceive the potential benefits to be worth the cost.
“I don’t think you could ever get a patient to pay for a, for them to personally pay for some sort of service surrounding high blood pressure, because it’s such a silent thing. Unless you're paranoid about your health, you don’t care.” P8
However, it was thought rural consumers may be more likely to accept and more willing to pay for additional pharmacy services, as they may have longer waiting times to see their GPs.
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“A lot of it is about access and stuff to other services, that people in the city ordinarily have … and particularly country people who have to wait three weeks to get in to see a doctor, they're more likely to come in and get a heart health check from us because their wife’s been nagging them for six years to go and see the doctor and they say ‘Well, I’ll go to the pharmacy instead’.” P8
Some GPs and pharmacists put the main burden of financial remuneration on the government. GPs suggested that pharmacist payment could occur by increasing the script service payment or by providing a bulk grant to provide the service. A Medicare subsidy or bulk-billing system were also mentioned as possible options for payment. It was commented that this would require the government to give pharmacists a provider number.
“Or whether there would be an increase in the script service payment …Or I suppose they can be given a bulk grant then do it with their hypertensive patients.” GP4
“And there should be some type of Medicare subsidy in some way for it. Just as there is one when they go and see the optometrist or they go and see the GP. I suppose when it comes to the health of the patient, have some type of reimbursement by the government. … Maybe just a bulk billing type of charging would be appropriate.” GP5
The amount of funding required for adherence programs seems to involve a complex balance of income. Pharmacists see themselves as having a monetary value per unit time, which is usually represented by the volume of dispensed prescriptions during that time period. Counselling was considered by pharmacists to be a service that has no direct monetary value, but may increase dispensing volume through goodwill and therefore generate more income.
“Yeah but you're only getting so much for scripts. There's no special incentive for you to spend the extra time with them. We had never charged for our advice, so you go and give advice every day to every patient and you go and spend ample time, that if you're looking at just purely money, you don’t account for any of that time wasted. It’s not wasted; you're building your custom and everything else.” P3
Spending time on an adherence service would reduce revenue from prescriptions, due to the pharmacist spending extended time consulting with individuals. Therefore, programs need to be sufficiently funded to compensate for the loss of dispensing volume or the cost of additional staff during that time. One pharmacist expressed the opinion that disease management services are the future of pharmacy, but that this will only be viable with adequate remuneration for these professional services.
“The guys that have got rich, that’s all they’ve done is pump out scripts, because the more scripts you pump out the more money you make. But it’s got to be the other way around if you want it to change. It’s got to be that the less time you spend pumping out scripts and the more time you spend counselling patients the more money you make, because then it’ll really change,” P8
Limitations
Due to technical difficulties with the audio-recording equipment, the consumer focus group, one GP and one pharmacist interview were unable to be transcribed verbatim. The observer’s supplementary notes were used to analyse these sessions’ emerging themes. Whilst these data provided rich information, direct quotes from these participants are not available; the observer notes have been used instead.
Discussion
From the focus groups and interviews with consumers, pharmacists and GPs, a number of adherence issues were identified. Regimen complexity, denial, lack of knowledge and delayed gratification were all recognised as common barriers. Medication side-effects, cultural barriers, cost of medication and complacency were also mentioned as possible barriers to adherence. These issues are similar to those reported in the adherence literature
8.
Potential ways suggested to improve adherence included the use of Dose Administration Aids (DAA) and SMS reminders. Any information (not just BP readings) that gives insight into possible adherence problems was considered useful. Patient education focusing on hypertension and its role in cardiovascular disease, its treatment and the importance of adherence were also considered important factors to improve adherence. Studies involving DAAs or patient education have been proven to significantly improve adherence
15,103,104. Repeated and
individualised rather than once-off educational sessions appear most beneficial.
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Blood pressure monitoring between GP visits, either at the pharmacy or at home by the patient, was thought to be beneficial to the success of adherence programs in community pharmacy.
Teamwork involving consumer, GP and pharmacist was also thought to be essential for the success of a pharmacy-driven adherence program. Consumer consent should be obtained before sharing information between their health professionals. GPs would like patients to be referred back to them for issues beyond the pharmacists’ capabilities.
Pharmacist training was seen as especially important, not only to update hypertension knowledge, but also to improve communication skills, including motivational interviewing skills. Published hypertension management guidelines also state the need for health professionals to use motivational techniques to encourage adherence
28.
Lack of adequate space within some pharmacies to conduct private consultations was mentioned as a major barrier to offering any pharmacy service focusing on chronic disease management, and needs to be addressed to ensure patient confidentiality.
All of these issues were addressed in the randomised controlled HAPPY trial. Components of the trial intervention package to improve adherence in patients on antihypertensive medicines mirror those strategies recommended by the stakeholders. These include education and motivational interviewing, pharmacy and home blood pressure monitoring, medication use reviews, and possibly dose administration aids, medication profiles and/or home medication reviews, as well as referral to a GP, when needed. Patient prescription reminders were also part of the intervention.
For the successful implementation of the program, the training for pharmacists had a strong focus on education about BP as a risk factor for CVD, protocols for management of BP, and adherence. Theory and practice in motivational interviewing were included to provide pharmacists with the skills to effectively communicate with consumers, be able to educate them, and develop strategies with individuals to address their adherence issues. While face-to-face training was provided, as suggested by the pharmacists interviewed, it was also made available online or by mail for those pharmacists who were unable or chose not to attend, as the inability to attend training has been a barrier to participation by pharmacists in other disease state management program research.
To address the issue of privacy, funding was made available to participating pharmacies to ensure they could provide a private consultation area within their pharmacy, such as acquiring a screen to section off part of the premises.
The main facilitator for successful implementation of a community pharmacy adherence program was seen to be remuneration for pharmacists. Remuneration for pharmacy services has been raised in previous studies
105,106.
Pharmacists felt that payment should be at least equivalent – if not more substantial – than money they could have earned by dispensing prescriptions during the consultation duration. Possible sources of remuneration mentioned were a service fee payable by consumers, drug company contributions and government funding. Government funding was the preferred option; possible payment strategies included Medicare rebate, bulk billing, bulk grant and increased dispensing service fee. In the randomised controlled trial, pharmacists were remunerated per patient according to the expected time involved.
Conclusion
The findings of the preliminary phase qualitative study are in line with those reported in the literature. This information guided the refinement of the intervention strategies for the randomised controlled trial phase of the project and also assisted in the development of the training program for pharmacists participating in the trial.
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Phase 3 Intervention Phase: Hypertension Adherence Program in PharmacY (HAPPY) Trial
The HAPPY trial was a multi-centre prospective randomised controlled trial (RCT).
Research objective and research questions
The research objective was to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications. Research questions were as follows:
1. Can the proposed intervention package service, compared to usual care: a. improve patient adherence and/or persistence with antihypertensive medications? b. improve patients’ blood pressure control? c. change patients’ health beliefs and attitudes? d. improve patients’ quality of life? e. generate more benefit at a cost (i.e., the Incremental Cost-Effectiveness Ratio, ICER) that is
reasonable and acceptable to the Australian society? 2. Are consumers and other stakeholders (Pharmacists and GPs) satisfied with the service? 3. Can the service be readily implemented within the current community pharmacy structure? What is the
consumer’s willingness to pay for the service? 4. Is there an economically viable business case for the service?
Primary outcome measures
The primary outcomes of the HAPPY trial were changes in patient adherence and persistence at the end of six months, measured subjectively using the self-reported Morisky scale
107 and the Tool for Adherence Behaviour
Screening (TABS)108
and objectively using medication refill data (e.g. MedsIndex109
, Medication Possession Ratio
110). The Morisky scale assesses both intentional and unintentional nonadherence and comprises four items.
Responses for each item are scored 1 for ‘yes’ and 0 for ‘no’ (except for the item ‘are you always careful in taking medicines?’, where the score is reversed) and added together. A total score of zero represents good adherence and a score of one or more represents suboptimal adherence. The TABS is another self-reported adherence measure, which was originally developed and validated in Australian patients using chronic medicines. It has two subscales – ‘adherence’ and ‘nonadherence’ – each comprising four items to be answered on a 5-point Likert-type scale (‘never’ – 1 to ‘always’ – 5). The total score for ‘nonadherence’ is subtracted from that of ‘adherence’; a differential of ≥15 was regarded as good adherence and ≤14 as suboptimal adherence for the purpose of this study. The TABS measures both intentional and unintentional deviations from recommended management and has been shown to have greater incremental validity than other self-reported adherence measures
108. The MedsIndex
gives each patient a score out of 100 for each of their long-term medications, calculated from their prescription refill history. Any score less than 100 suggests suboptimal adherence. The Medication Possession Ratio (MPR) was calculated as the sum of the days’ supply obtained over a series of intervals, divided by the total number of days from the beginning to the end of the time period.
No. tablets dispensed x (number of dispensings – 1) MPR = daily dose
No. of days between last and first dispensing
MPRs were calculated from the patients’ dispensing history within the pharmacy in which they were recruited. Repeat prescriptions collected at another pharmacy, where the trial pharmacy dispensed the first and last repeats, as well as dose and quantity changes over the period of time, were accounted for in the final MPR calculation.
Secondary outcome measures
Secondary outcomes included changes in patients’ blood pressure control, change in health beliefs and attitudes, changes in quality of life, satisfaction with and willingness to pay for the service, and economic benefits.
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Methodology
Study setting
Community pharmacies included in the trial came from metropolitan, regional and remote areas in three states of Australia (Victoria, Western Australia and Tasmania), proportionally stratified according to Pharmacy Access/ Remoteness Index of Australia (PhARIA) categories. (PhARIA provides a comprehensive, standardised rating of the physical and professional remoteness of pharmacies throughout Australia, for use in the determination of rural and remote pharmacy allowances. The concept of remoteness was based on the road distance people have to travel to reach a range of services.) The pharmacies were located in a range of physical locations such as shopping strips, shopping malls, within medical centres and stand-alone premises.
Pharmacy recruitment
Contact information for pharmacies was obtained from the telephone directory/Internet. Selected pharmacies in each of the PhARIA categories in each state were contacted by telephone and informed about the project. In addition, information about the project was circulated through The Pharmacy Guild in Western Australia and at a Pharmaceutical Society of Western Australia annual seminar. An explanatory statement (Appendix 9) was sent to all eligible pharmacies, if the pharmacist expressed interest.
Pharmacy eligibility criteria
Pharmacies were eligible to participate in the trial if they met all the following criteria (Appendix 10):
• used the pharmacy dispensing program ‘FRED Dispense®’; • agreed to install a software application (MedeMineCVD) to identify patients who are using or have used
antihypertensive medicines in the previous six months; • had at least 40 patients who were using or have used antihypertensive medicines in the previous six
months; • had a private counselling area within the pharmacy; • were willing and able to undertake project training either face-to-face or online; • had time within the working week to allocate about one uninterrupted hour per patient to collect the baseline
data; and • were able to follow-up participants for at least six months from baseline.
For participation of pharmacists in the trial, the following payments were made on a per-pharmacy basis:
• $500 for reimbursement of training, recruitment time and the possible purchase of a privacy screen • $100 per patient recruited into the Pharmacy Care Group (maximum of ten patients per pharmacy). • $50 per patient recruited into the Usual Care Group (maximum of ten patients per pharmacy). • $25 per patient recruited into the Hidden Control Group (maximum of ten patients per pharmacy).
Cluster randomisation
In each state, pharmacies were stratified according to PhAria and then randomised within strata to either Pharmacist Care Group (PCG) or Usual Care Group (UCG). Randomisation was carried out at the pharmacy level to avoid any contamination likely to result from the same pharmacy recruiting and following up both intervention and control group patients. Randomisation was carried out at a central location using the sealed opaque envelope technique.
To check for any ‘Hawthorne effect’111,112
in the UCG due to the effect of pharmacist contact with patients in the UCG, a third group of patients (Hidden Control Group - HCG) who were taking or had taken antihypertensive medicines in the previous six months (but not included in the UCG) were also identified from the UCG pharmacies.
Pharmacist training
Training was organised for participating pharmacists in two modes, face-to-face and online. Materials and resources were made available as hard copy, online and on CDs, to provide flexible learning opportunities. Training comprised two phases:
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Phase I
Phase I training was delivered to all participating pharmacists and included the project overview, patient recruitment including the use of MedeMineCVD software to identify patients using antihypertensive medications, calculation of MedsIndex score, use of BP monitors and collection of baseline data.
Phase II
The second phase focused on the importance of medication adherence in achieving optimal BP control, a clinical update on hypertension management, motivational interviewing, review of BP monitoring by patients, downloading home BP recordings, charting BP against adherence, and identification and resolution of medication-related hypertension by MUR.
Face-to-face training for Phase I (PCG and UCG) and Phase II (PCG only) was conducted in a one day training day before baseline data collection. For online training, only the phases relevant to the allocated trial group were made available. After the training, all participants’ knowledge was assessed (Appendices 11-12) and the training day evaluated (Appendices 13-14).
The UCG pharmacists received Phase II training towards the end of the study, so that their ‘usual care’ patients could be offered the interventions tested in the PCG after the six-month follow-up. This strategy was expected to encourage recruitment of pharmacists to the UCG and improve retention of patients in the UCG.
Intervention package
The PCG participants received a package of interventions from the pharmacist for enhancing their antihypertensive medication adherence, which included:
• a home BP monitor (Omron®HEM-790IT) with the capacity to store and download BP readings to be used
for discussion at three- and six-month follow-ups; • training by the pharmacist on self-monitoring of BP; • motivational interviewing and education by the pharmacist to help patients improve their medication
adherence and achieve target BP; • medication use review (MUR) where necessary to identify and resolve possible medication-related
hypertension (e.g. due to non-steroidal anti-inflammatory drugs, cold preparations, complementary medicines, etc.);
• pharmacist-initiated dose administration aid (DAA), home medicines review (HMR), and/or patient medication profile (PMP), where necessary;
• referral to a GP when needed (e.g. very high blood pressure); and • refill reminders, if they so chose, (by SMS, telephone or mail) from their pharmacist three days before their
antihypertensive medication was due to run out.
Promotion of project to general practitioners
GPs were not directly involved in the conduct of the project but it was acknowledged that their awareness was essential for an optimal multidisciplinary approach to patient care. Local General Practice Networks and Divisions were informed of the project so details could be communicated to members to raise awareness of the project. Individual GPs nominated by the patients were sent more detailed project information (Appendix 15) because communication with them occurred at several stages. These included confirmation of a participating patient’s hypertension diagnosis and their target blood pressure; and pharmacists advising if a patient’s blood pressure was found to be significantly elevated.
Sample size
Australian, European and North American studies have estimated that around 50% of patients initiating an antihypertensive medication discontinue their medication (become nonpersistent) within twelve months
20. To
demonstrate a 15% difference in adherence between the control and intervention groups at six months (e.g. 50% in the UCG versus 65% in the PCG) with 80% power and a two-sided p-value of 0.05, 182 patients were required per study group. To allow for potential drop-outs (approximately 25% over six months) the intent was to recruit 225 patients per group; i.e. a total of 450 patients at baseline.
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Patient recruitment
A software application, MedeMineCVD was installed on the dispensing computer of participating pharmacies. MedeMineCVD extracted data from widely used pharmacy dispensing software system in Australia (FRED Dispense
®) and identified patients who were using or had used antihypertensive medicines in the previous six
months. The purpose of MedeMineCVD was to:
1. preferentially identify patients who last had their antihypertensive medications dispensed more than 59 days previously and those with suboptimal refill adherence or both;
2. generate personalised “Expression of Interest” (EOI) letter to mail to potential patient participants. Once the completed EOI was received by the pharmacist and eligibility was confirmed, the information was recorded in MedeMineCVD;
3. generate the participant explanatory statement and consent form, as well as a letter and fax-back form to be sent to the participant’s GP to confirm diagnosis of primary hypertension and advise of the participant’s target BP;
4. manage participant appointments by pharmacists;
5. create a unique identification number for each participant, which was printed on all study documents (e.g. data collection forms and letters);
6. send optional SMS reminders or prompt the pharmacist to telephone or send mail reminders to participants when their medication supplies should have been dwindling; and
7. record data related to the trial to enhance and simplify analysis.
An Expression of Interest invitation letter (EOI) (Appendix 16) with a short questionnaire (seeking information about the patient’s BP, interest in participation, nominated GP, including contact details and consent to contact the GP, and patient telephone contact details) and a reply-paid envelope were sent to potential participants. Patients were asked to return the completed questionnaire to the pharmacy and indicate their interest in participating. Once the EOI was received, the pharmacist contacted the patient to further assess their eligibility (Appendix 17) and arrange a mutually convenient time for them to visit the pharmacy to enrol in the study. The pharmacist also contacted the patient’s GP at this time. If eligibility was confirmed, an explanatory statement (Appendix 18) was supplied.
Inclusion criteria
• using, or having used in the last six months, at least one antihypertensive medication belonging to four common classes of antihypertensives in Australia – angiotensin converting enzyme inhibitors, angiotensin-II receptor antagonists, calcium channel blockers, beta blockers – (http://www.aihw.gov.au/publications/cvd/mfchatua/mfchatua.pdf) or fixed combinations of antihypertensive medications belonging to the above classes with other antihypertensives (e.g. diuretics);
• a diagnosis of primary hypertension; • 18 years or above; and • available for follow-up for at least six months from baseline.
Exclusion criteria
• participation in other adherence promotion programs; • having had a pharmacist-conducted HMR service in the last 12 months; • unable to communicate in English; and • not self-administering antihypertensive medicines.
Data collection
Baseline visit
During the baseline visit to the pharmacy, the pharmacist measured the patient’s BP using a digital BP monitor (average of two readings as per WHO MONICA
113 and EHRM
114 protocols – if these differed by more than 10
mmHg for systolic or 5 mmHg for diastolic, a third reading was taken and the average of the two closest readings recorded). Each pharmacy was provided with a BP monitor (Omron®HEM-790IT). The MedsIndex score was calculated for each antihypertensive medicine the patient used. Adherence was measured using self-report tools – the Morisky scale and the TABS. The Beliefs and Behaviour Questionnaire
108 was used to assess patient
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experiences, attitudes and beliefs regarding their health and treatment and the eight-item short Assessment of Quality of Life (AQoL)
115 was used to measure health-related quality of life. The pharmacist also collected
information on the patient’s medications and their understanding of and ability to use these medications. Patients in the PCG then received the intervention described earlier. The baseline data collection form is attached as Appendix 19.
Three-month visit
Pharmacist Care Group (PCG) Only During the patient’s visit to the pharmacy at three months, the pharmacist administered the Morisky scale and TABS. The pharmacist also:
• measured the patient’s BP (as described above); • documented any adherence issues and actions taken; • intervention based on the patient’s downloaded home BP measurements; and • referred the patient to their GP, if needed (e.g. persistent uncontrolled BP even after improvement in
adherence).
The three-month data collection form is attached as Appendix 20.
Six-month (final) visit
Measures performed at baseline were repeated for both UCG and PCG patients at their six-month visit to the pharmacy. The six-month data collection form is attached as Appendix 21.
Usual Care Group (UCG) Only
Following final measurements, each UCG participant was eligible to receive the same package of interventions offered to the PCG at baseline, apart from the option to receive prescription refill reminders.
Hidden Control Group
The difference in adherence to anti-hypertensive medications between the HCG and the UCG patients was analysed using the MedsIndex scores and the Medication Possession Ratios (MPRs).
Baseline MPRs for all antihypertensive medicines were calculated for the six months prior the consumer’s baseline appointment. Six-month MPRs were calculated from the baseline appointment to the end of the trial. The difference was calculated between the six-month and baseline MPRs. These figures were used to detect any difference between the UCG and HCG. As there were instances where a patient may have been taking more than one anti-hypertensive medication, the lowest MPR, highest MPR and average MPR for each patient were each analysed to detect any differences.
At six-months, MedsIndex scores for all antihypertensive medicines were collected for the UCG and HCG patients. The lowest MedsIndex scores were used to compare differences between the groups.
Statistical analysis
Analysis was performed using SAS version 9.2 (SAS Institute Cary, NC, USA). Paired t-tests (or Wilcoxon Sign Rank) were used to determine within group changes, whilst unpaired t-tests (or Wilcoxon Rank Sum) were used to compare between group differences.
Ethical issues
This project was approved by the Human Research Ethics Committees of Monash University, Curtin University of Technology and The University of Melbourne, and the Human Research Ethics Network of Tasmania. All pharmacists and patient participants (in the UCG and PCG) provided written informed consent (Appendices 22-23) at the time of enrolment.
Approval to access dispensing data for the HCG was given on the basis that pharmacists have routine access to this data about their patients via the dispensing program and would use it in normal practice to routinely check their patients’ history for actual or potential medication-related problems.
The researchers had access only to de-identified patient data.
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Data storage
With respect to privacy, confidentiality and document de-identification, data were treated and retained in a manner consistent with Monash University ethical requirements and Victorian, Tasmanian, Western Australian and Commonwealth legal requirements. Data reporting was undertaken in a manner that maintained anonymity of individual patients, participating pharmacists and GPs.
Economic Evaluation and Business Case
Economic Evaluation
Cardiovascular disease impacts on the mortality, morbidity and quality of life of the patient as well as on the Australian health care system. As such it is crucial to evaluate the prevention of cardiovascular disease from the perspectives of both patients and the health care system. The economic evaluation performed in this study was a full economic evaluation in which both effectiveness and cost were examined and compared between the intervention group (PCG) and the comparator (UCG).
Measurement of Effectiveness
Effectiveness in this study is measured in terms of the Quality Adjusted Life Years (QALYs) gained, where quality of life was measured using AQoL8 (Assessment of Quality of Life 8 questionnaire, version 3)
116,117 at the patient
level. AQoL is the only Australian-developed instrument that measures quality of life and has been validated using the Australian population to generate utility scores. It consists of eight questions and the utility score is calculated from the algorithm provided by the author of AQoL8.
There are three reasons for choosing AQoL8 to measure the quality of life of patients in this study. The first is that the validity and reliability of this instrument have been established. The second is that it measures quality of life from an Australian perspective. The third is that it contains the fewest questions among the AQoL series, which can enhance the feasibility of performing the survey without losing validity and reliability due to low response rates. The patient’s utility score produced by AQoL8 is scored on a life-death scale between 1 and -0.04, where 1.00 represents perfect health; 0 is the equivalent of death and negative values represent states worse than death.
Measurement of Costs
Costs are involved for both service providers and patients. Regarding the service provider, the cost is associated with the type of service provided and is measured by identifying the resource items used in the service, the quantity of units used for each item, and the unit price of each item. For example, the time spent by pharmacists delivering the service is an important cost. The cost of each pharmacist’s input is measured by the time in minutes (i.e., the unit) spent to deliver the service. The unit price is the hourly wage rate of the pharmacist (plus on-costs). A widely recognised difficulty of measuring cost is that there is virtually no standard method of calculating cost
118,119; that is,
there is no universally accepted standard cost list for economic evaluations to date. Each study must decide its own cost items to be included, based on the scope and purpose of the evaluation.
In this study, according to the rule of importance118
, all related major cost items have been included. On the provider side, there are two major costs: (1) fixed cost, i.e., the initial investment that would be required for setting up the service and providing special training to enable pharmacists to perform the new service specified in the intervention for this trial; (2) variable cost, i.e., the pharmacist labour input (i.e., pharmacist’s time) for providing the new service. All other costs to the provider are omitted due to their insignificance in the total costs of the provider
Regarding the patient, there are three major costs involved in this new service: (1) the cost of the blood pressure monitor used at home; (2) medical costs, such as medications for treating cardiovascular disease, cardiovascular disease-related GP visits, Emergency Department visits, and hospital stay; and (3) other associated out-of-pocket costs, such as co-payments and travel expenses, etc.
The measurement of each cost item, unit price, sources of information on cost and how such data were collected are reported in the Results section.
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Cost-effectiveness analysis
Analyses were performed using SPSS version 18.0 and Microsoft Excel 2003. The level of significance for all tests was set at the conventional level of 5% (i.e., p<0.05). After calculating and obtaining the results of the effectiveness and the cost for both arms in the study (i.e., PCG and UCG), cost-effectiveness analysis was performed using Incremental Cost-Effectiveness Ratio (ICER) Analysis (formula shown below)
118,119.
where ∆ Cost = difference in cost
∆ Effectiveness: difference in effectiveness
The denominator in this study is the difference in QALYs gained between the PCG and the UCG. The numerator is the difference in the total major costs between the two groups. This ratio can indicate whether a health intervention, as compared to the comparator (in this case, usual care), has generated more benefits relative to the additional cost. Although no written gold standard regarding the threshold of ICER can be found in Australia, the incremental cost-effectiveness of a health intervention (i.e., prescription drugs) under AU$70,000 per QALY is reported as being eligible for funding by the Pharmaceutical Benefits Scheme (PBS) of the Australian Government
120.
However, in this study, the participants were followed up for only six months, which is too short a time to demonstrate the full benefit and full cost of the intervention and the comparator. Therefore, it is necessary to conduct an extrapolation based on the results of six months follow-up to estimate the longer term cost-effectiveness. The long-term cost-effectiveness of the Pharmacist Care intervention was modelled using a Markov process
121-123 over a time horizon of ten years. Discounting rate was 5% in the ten-year model of the base case,
which is a standard practice in Australia. Sensitivity analysis was also performed to examine the impact of uncertainty on the effectiveness and cost, and thus on the conclusion of the cost-effectiveness analysis. This part of the analysis included 0% and 10% discount rates for the ten-year model, and addressed variations in the quality of life utility scores; variation in costs of the pharmacist’s time of delivering the new service; and the patient’s emergency department visits and hospital stays in the ten-year model on the ICER.
Business Case
The following questions are addressed in the business case evaluation so that the information collected in this study can help to formulate a business case similar to “The Pharmacy Guild of Australia Business Case for Participation in the PMP Program – Phase 1”
124 and “The Pharmacy Guild of Australia Business Case for
Participation in the DAA Program – Phase 1”125
:
1. Are the trial intervention services performed by community pharmacist cost-effective in hypertension/CVD prevention and management?
2. What is the cost to the pharmacy for setting up this service? 3. What is the cost to the pharmacy for providing this service? 4. How much is the patient is willing to pay for this service? 5. Who should pay for the service and how should it be financed?
Regarding questions 1, 2 and 3, information was drawn from the economic evaluation part of Phase 3 of the study. Information for Question 4 came from the Business Case Questionnaire (Appendix 24). Information for Question 5 was obtained from the stakeholders’ focus groups and interviews in Phase 2 (pre-trial) and Phase 4 post-trial.
In general terms, consumers would have difficulty responding to a question on willingness to pay (WTP) when a service has not yet been on the market. Two methods are commonly used by researchers
126-128. One is to give the
respondent a narrative of hypothetical scenario of the new service, use a show card with a few price figures (or list the prices in the self administered questionnaire) and ask the respondent to indicate his or her willingness to pay for the hypothetical good or service described in the scenario. The other method is to use an open question, “How much are you willing to pay for the service described to you?” The former method can give the respondent a concrete idea of the corresponding price for a good or service, but the price figures may influence the respondent’s original willingness to pay after seeing these figures. With the method of using an open question, the respondent may give a wider range of answers due to his/her difficulty in judging the value of a good or service that they have not experienced. In this study, in order to have better knowledge about consumers’ original willingness to pay, we have chosen the second method with modification. That is, the same respondent has been asked the same
essEffectiven
CosttiotivenessRalCostEffecIncrementa
∆
∆=
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question twice, at the baseline when the respondent has not experienced the service described and at the six-month follow-up visit when the consumer has experienced the service.
In addition to WTP, several other related questions were asked, such as the frequency of shopping in the pharmacy, amount of spending per visit and satisfaction with the pharmacy. The evaluation of the business case was applied to the patients in the PCG only because the patients in the UCG had no experience of the new pharmacist service. Table 3 summarises the definitions/descriptions of the measurements included for business case evaluation.
Table 3: Definitions/descriptions of measurements for business case evaluation
Measurement Description of the questions in the questionnaire
Willingness To Pay
If there is a new service package available, say, the pharmacist can help you to better manage hypertension/heart disease by monitoring blood pressure and providing consultation regularly, how much are you willing to pay (maximum dollar) for this additional service per month (one to two visits to the pharmacist)?
Shopping Frequency
How often did you shop at this pharmacy during the past six months?
Frequency has been transformed into total visits over six months. For example, once a week is counted as 26, every two weeks counted as 13, every three weeks counted as 8.7, once a month or less counted as 6
Spending per visit
During the past six months, how much did you spend at this pharmacy (on average) during each visit (including medicine and other goods)?
Satisfaction What is your overall satisfaction with this pharmacy? (1: very unsatisfied to 7: very satisfied)
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Results – Randomised Control Trial
Pharmacies
Pharmacy recruitment
A total of 55 pharmacies were recruited into the project; 29 were randomised into the Pharmacist Care Group (PCG) and 26 into the Usual Care Group (UCG). Reasons for falling short of the planned number of 60 pharmacies included pharmacists withdrawing before the start of the baseline (3 from Victoria, 1 from Tasmania) and FRED Dispense
® not being widely used in the state of Western Australia (1). In Victoria, one PCG pharmacy
left the study after baseline data collection due to changes in ownership of pharmacy and the new owner declining to participate further.
Stratification of pharmacies
Of the 55 pharmacies recruited into the study, 40 were from Victoria (20 in PCG; 20 in UCG), nine from Western Australia (5 PCG; 4 UCG) and six (4 PCG; 2 UCG) from Tasmania. Just over two-thirds (67.3%) were located in PhARIA 1. The PhARIA categories of selected pharmacies from each state are presented in Table 4.
Table 4: Stratification of pharmacies
PhARIA Victoria Western Australia Tasmania Total
1 29 6 2 37
2 4 1 0 5
3 2 0 3 5
4 3 1 0 4
5 1 0 1 2
6 1 1 0 2
Total 40 9 6 55
Pharmacy banners
Just over half (56.4%) of the participating pharmacies were independent. The remining pharmacies belonged to eight banner groups. The details of pharmacy banners in each state are presented in Table 5.
Table 5: Pharmacy banners
Pharmacy banner Victoria Western Australia Tasmania Total
Amcal 4 1 3 8
Chemmart 1 0 0 1
CO-Pharmacy 0 1 0 1
Friendlies 0 1 0 1
Guardian 3 1 0 4
Quality Care 3 0 0 3
Priceline 3 0 1 4
Pulse 2 0 0 2
Independent 24 5 2 31
Total 40 9 6 55
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Pharmacy location
Just over half (52.7%) of the pharmacies were located along shopping strips with a small number (10.9%) attached to medical centres. Eleven (20.0%) pharmacies were located in shopping malls while nine (16.4%) were stand alone pharmacies. The details of pharmacy locations in each state are presented in Table 6.
Table 6: Pharmacy location
Location Victoria Western Australia Tasmania Total
Shopping strip 25 3 1 29
Shopping mall 7 3 1 11
Medical centre 3 2 1 6
Stand alone 5 1 3 9
Total 40 9 6 55
Training of pharmacists
A total of 18 pharmacists (from 17 pharmacies) attended the training day and 39 pharmacists (from 38 pharmacies) did the training either online or using the CD provided. Details of training for each state are presented in Table 7.
Table 7: Pharmacist training attendance
Type of training Victoria Western Australia
Tasmania Total
Face-to-face (PCG) 8 2 0 10
Face-to-face (UCG) 6 2 0 8
Face-to-face (Total) 14 4 0 18
Online/CD (PCG) 14 3 4 21
Online/CD (UCG) 14 2 2 18
Online/CD (Total) 28 5 6 39
Total 42 9 6 57
Assessment of knowledge of PCG pharmacists
Of the 31 PCG pharmacists who undertook the training, 24 (77.4%) completed the assessment of their knowledge after the training. Sixteen (66.7%) completed the assessment on paper and 8 (33.3%) submitted it online. The majority of pharmacists answered each of the questions correctly. The number of pharmacists who answered correctly for each topic is presented in Table 8.
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Table 8: Assessment topics for PCG pharmacists (% correct responses)
Question N (%)
Hypertension 1) Definition of blood pressure 2) Measurement of a patient’s blood pressure
17 (70.8) 24 (100)
Cardiovascular disease 1) Risk of cardiovascular disease
22 (91.7)
Antihypertensive agents 1) Drug classes 2) Action taken to retify unresponsive single antihypertensive agent 3) Safest and effective combination of drugs
23 (95.8) 21 (87.5) 17 (70.8)
Noncompliance 1) Noncompliance risk factor 2) Compliance interventions 3) Definition of nonpersistence 4) Medicine adherence improves with severity of the disease 5) ‘Gold standard’ for measuring adherence
17 (70.8) 19 (79.2) 23 (95.8) 19 (79.2) 17 (70.8)
Motivational interviewing 1) Definition of motivational interviewing 2) The OARS Model of motivational interviewing
12 (50.0) 22 (91.7)
Project process 1) Next step after MedeMine 2) Steps to be taken before baseline data collection 3) Questions about reminders (total of 3 questions)
21 (87.5) 23 (95.8) 54 (79.7)
Assessment of knowledge of UCG pharmacists
Of the 26 UCG pharmacists who undertook training, 22 (84.6%) completed their assessment. Thirteen (59.1%) completed the assessment on paper and 9 (40.9%) finished it online. The majority (21/22, 95.5%) of pharmacists answered at least half of the questions correctly. The number of pharmacists who answered correctly for each topic is presented in Table 9.
Table 9: Assessment topics for UCG pharmacists (% correct responses)
Question N (%)
In the recruitment of patients, after patients have been identified by MedeMine what is the next step?
22 (100)
Before you can begin collecting data at baseline, what things must be completed? 19 (86.4)
True or false statements:
After the baseline appointment if you have been identified adherence issues you should not take any action to improve adherence
14 (66.7)
Despite being in a control group, if the patient has uncontrolled high blood pressure you should refer them to the GP
20 (95.2)
All recruited patients uin the Usual care Group will receive the project interventions after the 6-month trial
18 (81.8)
Evaluation of training – PCG pharmacists
Of the 31 pharmacists, 19 (61.3%) completed their evaluation of the training provided. Sixteen (84.2%) completed the evaluation on paper and three (15.8%) submitted it online. Because the evaluation survey was anonymous, it was not possible to identify whether respondents had attended face-to-face or attempted online/CD training. The main reasons that the pharmacists chose to participate in the project were their interest in hypertension and/or pharmacy research in general, and helping their customers. Equal numbers of pharmacists (47.4%) reported that the training met their expectations or remained neutral. Only one said that the training did not meet expectations. Three-quarters of pharmacists (75%) believed that the contents were relevant to their practice. Just under half (47.4%) found the amount of information in the training manual was reasonable. Just over half (56.2%) felt that the
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amount of information provided on training day was reasonable. The majority of pharmacists felt that the topic covered at each session on the training day was good. Just over three-quarters of the pharmacists (76.5%) found that the materials in the training manual and the topics covered on the training day were relevant to their practice. The majority of pharmacists (82.4%) were confident in applying the knowledge gained from the training to their practice. The details of evaluation of PCG training are presented in Table 10.
Table 10: Evaluation of PCG training
Question N (%)
Two main reasons for participation in the project
• Interest in hypertension • Interest in pharmacy research in general • Helping the customers
11/19 (57.9) 9/19 (47.4) 9/19 (47.4)
Extent of the training meeting expectations
• Poorly • Neither poorly nor well • Well/very well
1/17 (5.8)
8/17 (47.1) 8/17 (47.14)
Relevance of content to practice
• Irrelevant • Neither irrelevant nor relevant • Relevant/very relevant
1/16 (6.2) 3/16 (18.8) 12/16 (75.0)
Amount of information provided in the training manual
• Little • Neither little nor much • Much
2/19 (10.5) 9/19 (47.4) 8/19 42.1)
Amount of information provided on the training day
• Little • Neither little nor much • Much
3/16 (18.7) 9/16 (56.2) 4/16 (25.1)
Training day sessions Patient recruitment
• Good to excellent Data collection process
• Good to excellent Blood pressure monitors
• Fair • Good to excellent
Trends in managing BP
• Fair • Good to very good
Medication adherence
• Fair • Good to very good
Motivational interviewing
• Fair • Good to excellent
Intervention strategies
• Fair • Good to excellent
14/14 (100)
14/14 (100)
1/15 (6.7) 14/15 (93.3)
1/14 (7.1)
12/14 (92.9)
1/15 (6.7) 14/15 (93.3)
2/15 (13.3) 13/15 (86.7)
1/14 (7.1)
13/14 (92.9)
Relevance to the project of the clinical and practical information provided in the training manual and training sessions
• Irrelevant • Neither irrelevant nor relevant • Relevant
3/17 (17.6) 1/17 (5.9)
13/17 (76.5)
Confident in applying the training into practice • Neither confident nor not confident • Confident
3/17 (17.6) 14/17 (82.4)
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Evaluation of training – UCG pharmacists
The majority of pharmacists (21/26, 80.8%) completed an evaluation. Sixteen (6.2%) finished a paper evaluation and 5 (23.8%) submitted it online. The two main reasons the pharmacists participated in the project were their interest in pharmacy research in general and helping their customers. Almost two-thirds (64.7%) reported that the training day met their expectation. High proportions of the pharmacists reported that the amount of information provided on training day was just right (80%), that the amount of information in the training manual was reasonable (85%), and that they felt confident to apply knowledge gained from the training in their practice (83.3%). The details of evaluation of UCG training are presented in Table 11.
Table 11: Evaluation of UCG training
Question N (%)
Two main reasons for participation in the project
• Interest in pharmacy research in general • Helping the customers • Pharmacy payment
8/21 (38.1) 8/21 (38.1) 7/21 (33.3)
Extent of the training meeting expectations
• Poorly • Neither poorly nor well • Well to very well
1/17 (5.9)
5/17 (29.4) 11/17 (64.7)
Amount of information provided in the training manual
• Little • Neither little nor much • Much
1/15 (6.7)
12/15 (80.0) 2/15 (13.3)
Amount of information provided in the training day
• Little • Neither little nor much
• Much
3/16 (18.7) 9/16 (56.2) 4/16 (25.1)
Training day sessions Patient recruitment
• Good to excellent Data collection process
• Good Blood pressure monitors
• Poor • Fair • Good to excellent
15 (100)
15 (100)
1 (6.7) 1 (6.7)
13 (86.7)
Relevance to the project of the clinical and practical information provided in the training manual and training sessions
• Irrelevant • Neither irrelevant nor relevant • Relevant
1 (5.9) 2 (11.8)
14 (82.3)
Confident in applying the training in to practice
• Neither confident nor not confident • Confident
3 (16.7)
15 (83.3)
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Patients
Patient recruitment flowchart
Patients identified by MedeMineCVD (n = 12,551)
Patients identified in the PCG (n = 6,794) Patients identified in the UCG (n = 5,832)
Patients randomised to the UCG (n = 2,908)
Patients randomised to the HCG (n = 2,924)
EOIs sent (n = 1,257) EOIs sent (n = 894)
EOIs returned (n = 335) EOIs returned (n = 306)
Eligible for inclusion in the trial (n = 241) Eligible for inclusion in the trial (n =216)
Participants at baseline (n = 188) Participants at baseline (n = 207)
Names shown to pharmacists (n = 1636) Names shown to pharmacists (n = 1191)
Participants at 3 months (n = 190)
Participants at 6 months (n = 178) Participants at 6 months (n = 176)
Patients identified by MedeMineCVD (n = 12,626)
Patients identified in the PCG (n = 6,794)
EOIs sent (n = 1,257)
EOIs returned (n = 335)
Eligible for inclusion in the trial (n = 241)
Participants at baseline (n = 207)
Names shown to pharmacists (n = 1636)
Participants at 3 months (n = 190)
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Baseline characteristics of recruited patients
Demographic profile
A summary of the baseline characteristics of patients is shown in Table 12. At baseline, 207 patients were enrolled in the PCG and 188 in the UCG.
In the PCG (n=207), 52.2% of participants were female. The average age of the patients was 67.0 ± 12.1 years. Two-thirds (66.2%) were in a relationship and just over two-thirds were born in Australia (68.1%). Most (88.9%) reported having at least secondary/high school education. Almost 80% of patients had an average household gross income of less than $75,000. More than two-thirds (72.9%) had concessional benefits. Seventy- three (35.3%) reported having CVD, 40 (19.3%) having diabetes, and 35 (16.9%) suffered depression. The median score of the Charleson Index was 2 (range 0 - 8). Overall, the patients reported modest quality of life (0.71 ± 0.24). The range of scores is from 1.00 (best health state), to -0.04 (health state worse than death); death being represented by 0.00.Just over half (51.7%) reported that they would change their medicine if it were required for BP reduction. Thirty-eight (18.4%) reported they had difficulty in understanding their medicines due to different brands of the same medicine. Thirty-six (17.4%) reported that they use some type of medicine box to help them to remember to take their medicines. The proportion of patients who were nonadherent to their antihypertensive medicines was shown by the Morisky scale to be 43.1% (85/197), the TABS differential 88.5% (177/200), and MedsIndex score 58.9% (122/207.
In the UCG (n=188), 45.4% of participants were female. The average age of the patients was 67.0 ± 11.8 years. Two-thirds (69.5%) were in a relationship. Three-quarters (74.5%) were born in Australia. The majority of patients (90.5%) reported having at least secondary/high school education. Almost 85% of patients had average household gross income of less than $75,000. Just over two-thirds (69%) had concessional benefits. Seventy-four (39.4%) reported having CVD, 31 (16.5%) having diabetes and 34 (18.1%) depression. The median score of the Charleson Index was 2 (range 0 – 9). Overall, the patients reported modest quality of life (0.71 ± 0.24). Just over two-thirds (68.1%) reported that they would change their medicine if it were required for BP reduction. Twenty-seven (14.4%) reported they had difficulty in understanding their medicines due to different brands of the same medicine. One-quarter (24.5%) of the patients reported that they used a medicine box to help them to remember to take their medicines. With regard to adherence measures, the Morisky scale showed 42.5% (79/186), TABS differential 84.9% (158/186), and MedsIndex score 55.9% (105/188) of patients were nonadherent to their antihypertensive medicines.
Overall, there were no statistically significant differences between the characteristics of the two groups at baseline.
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Table 12: Baseline characteristics of participants
Baseline demographic features PCG UCG p Gender 0.17 Women [N (%)} 108 (52.2) 85 (45.4) Men [N (%)] 99 (47.8) 103 (54.8) Age 0.86 Mean age (years) ± SD – women 66 ±12.3 67 ±11.7 Mean age (years) ± SD – men 68 ±11.8 67 ± 11.8 Marital status 0.37 Married [N (%)] 131 (63.3) 124 (66.3) Cohabiting/partnered/defacto [N (%)] 6 (2.9) 6 (3.2) Widowed [N (%)] 34 (16.4) 27 (14.4) Single [N (%)] 7 (3.4) 15 (8.0) Separated [N (%)] 6 (2.9) 8 (4.3) Divorced [N (%)] 23 (11.1) 7 (3.7) Background 0.16 Aboriginal or Torres Strait Islander [N (%)] 0 (0) 1 (0.5) Born in Australia [N (%)] 141 (68.1) 140 (74.5) Highest level of Education 0.07 Primary education only or no formal education [N (%)] 23 (11.1) 18 (9.6) Secondary education /high school [N (%)] 123 (59.4) 98 (52.2) Technical or TAFE education [N (%)] 34 (16.4) 30 (16.0) University education [N (%)] 27 (13.0) 42 (22.3) Annual household gross income 0.84 Less than $75,000 [N (%)] 154 (79.4) 139 (84.8) $75,000 or more [N (%)] 40 (20.6) 25 (15.2) Concessional benefits [N (%)] 151 (72.9) 129 (69.0) 0.39 Diagnosed health conditions CVD (stroke and heart conditions) [N (%)] 73 74 0.40 Diabetes [N (%)] 40 31 0.46 Depression [N (%)] 35 34 0.76 Charlson’s index [median (range)] 2 (0-8) 2 (0-9) 1.00 Quality of life [mean (sd)] 0.71 ± 0.24 0.71 ± 0.24 0.88 Use of medicines: Willingness to trial different BP reduction strategies, if necessary [N (%)]:
Change of medicine 107 (51.7) 128 (68.1) Change of lifestyle 101 (48.8) 120 (62.8) Higher doses of current medicine(s) 99 (47.8) 112 (59.6) Additional medicine(s) 83 (40.1) 98 (52.1) Medicines management difficulties [N (%)] Understanding different brands of the same medicines 38 (18.4) 27 (14.4) Difficulty getting to the doctor/pharmacy when medicines run out 22 (10.6) 12 (6.4) Difficulty swallowing medicines 16 (7.7) 16 (8.5) Difficulty opening containers 15 (7.2) 15 (8.0) Problems with reading and understanding labels 9 (4.3) 4 (2.1) Reported use of medicines adherence aids [N (%)] Medicine box 36 (17.4) 46 (24.5) Medicine list 14 (6.8) 8 (4.3) Assistance from relative/carer 13 (6.3) 10 (5.3) Calendar 10 (4.8) 4 (2.1) Diary 4 (1.9) 4 (2.1) Alarm beeper 1 (0.5) 3 (1.6) Prevalence of medicine nonadherence as per different measures [N (%)]
In the PCG, the reported median systolic blood pressure was 141 mmHg and the median diastolic BP was 83 mmHg. The median systolic blood pressure in UCG patients was 138 mmHg and the median diastolic BP was 84 mmHg. There were no statistically significant differences between the two groups in these measurements. Details of the systolic and diastolic BP for the PCG and UCG are presented in Table 13.
Table 13: Mean systolic and diastolic BP for PCG and UCG
Changes to key parameters at three months (PCG group only)
The three-month visit was completed by 190 PCG patients.
One hundred and fifteen (115/181, 63.5%) patients showed no change in their Morisky score between baseline and three months; 89 (49.2%) remained adherent and 26 (14.4%) remained nonadherent. Forty-four (24.3%) showed a trend towards adherence and 22 (12.2%) towards nonadherence. There was a statistically significant difference between the baseline and three-month Morisky scores (p=0.006) indicating that patients had become more adherent to their hypertensive medications.
Twenty-seven (27/173, 15.6%) patients showed no change in the TABS between baseline and three months; 10 (5.8%) remained adherent and 17 (9.8%) remained nonadherent. Eighty-five (49.1%) showed a trend towards adherence and 61 (61/173, 35.3%) towards nonadherence. There was no statistically significant difference between the baseline and three-month figures (p=0.148).
There was a statistically significant reduction in patients’ recorded BP measurements from baseline to three-months; 8 mmHg for systolic (p<0.001) and 4 mmHg for diastolic (p<0.001).
Changes to key parameters at six months
At the six-month visit, data were collected for 354 consumers, 176 in the UCG and 178 in the PCG.
Changes in adherence
Differences in the proportion of participants in each group who were judged to be adherent according to various measures were explored. Of the 173 UCG and 170 PCG participants for whom Morisky scores were calculated at baseline and six months, the proportion judged to be adherent by this measure increased from 57.2% to 63.5% (+6.3%) in the UCG and 60.0% to 73.5% (+13.5%) in the PCG. Thus, a crude difference of 15% between the groups, which the trial was powered to detect, was not demonstrated. The proportions judged to be adherent using TABS and MedsIndex remained consistent from baseline to six months (<5% change).
In addition, it was observed that not all participants improved their adherence over the time period (Figure 3). No significant difference was observed between the groups (p>0.1).
Figure 3: Difference in adherence rate as judged by the Morisky scale
There were improvements in adherence scores on varno statistically significant differences between the groups. The Morisky score increased significantly in bothbut more so in the PCG. The TABS nonadherenceMedsIndex score for BP medicines increasein the medication possession ratio in both groups. UCG and PCG are illustrated in Table 1
11.2 10.4
0
10
20
30
40
50
60
70
80
Became nonadherent
Pe
rce
nta
ge
of
pa
rtic
pa
nts
(%
)
Adherence rates changes
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as judged by the Morisky scale from baseline to six months
erence scores on various measures of adherence at sixsignificant differences between the groups. The Morisky score increased significantly in both
The TABS nonadherence score decreased significantly in the UCGMedsIndex score for BP medicines increased significantly in the PCG alone. There were significant improvements in the medication possession ratio in both groups. The changes in patient adherence over
14.
64.1
24.7
72.8
16.8
Did not change Became adherent
Adherence rates changes
PCG (n=170)
UCG (n=173)
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from baseline to six months
ious measures of adherence at six- months, but there were significant differences between the groups. The Morisky score increased significantly in both groups,
score decreased significantly in the UCG, however the There were significant improvements
over the six-month period in
PCG (n=170)
UCG (n=173)
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Table 14: Changes in adherence between baseline and six months
Measure of adherence Baseline Six months p
Morisky total score median (IQR); mean ± SD
UCG (n = 173) 0 (0 – 1)
0.59 ± 0.82 0 (0 – 1)
0.44 ± 0.64 0.030 (Sign Rank)
PCG (n = 170) 0 (0 – 1)
0.56 ± 0.75 0 (0 – 1)
0.36 ± 0.67 0.019 (Sign Rank)
Difference between UCG and PCG 0.31 (Wilcoxon Rank)
TABS adherence score median (IQR); mean ± SD
UCG (n = 170) 20.0 (19.0 – 20.0)
19.12 ± 1.93 20.0 (19.0 – 20.0)
19.07 ± 1.65 0.852 (Paired t-test)
PCG (n = 170) 19.0 (18.0 – 20.0)
18.35 ± 2.73 20.0 (18.0 – 20.0)
18.83 ± 2.15 0.179 (Paired t-test)
Difference between UCG and PCG 0.234 (t-test)
TABS nonadherence score median (IQR); mean ±SD
UCG (n = 170) 8.0 (6.0 – 10.0)
8.20 ± 2.89 8.0 (5.0 - 9.0) 7.52 ± 2.60
0.021 (Paired t-test)
PCG (n = 168) 8 .0(6.0 – 10.0)
8.10 ± 2.71 7.0 (5.0 – 10.0)
7.74 ± 2.98 0.154 (Paired t-test)
Difference between UCG and PCG 0.580 (t-test)
TABS differential median (IQR); mean ± SD
UCG (n = 165) 11.0 (8.8 – 14.0)
10.92 ± 3.67 12 (10.0 – 16.0)
11.59 ± 3.33 0.063 (Paired t-test)
PCG (n = 164) 11.0 (8.0 – 13.0 )
10.25 ± 3.77 12.0 (9.0 – 14.0)
11.10 ± 3.83 0.111 (Paired t-test)
Difference between UCG and PCG 0.856 (t-test)
MedsIndex score for BP medicines median (IQR); mean ± SD
UCG (n = 142) 87.0 (68.0 -97.0)
80.42 ± 20.23 90.0 (71.5 – 99.0)
82.86 ± 19.42 0.229 (Paired t-test)
PCG (n = 133) 85.0 (70.0 – 96.0)
80.15 ± 18.36 91.5 (73.8 – 99.0)
84.75 ± 17.13 0.002 (Paired t-test)
Difference between UCG and PCG 0.228 (t-test)
Medication Possession Ratio median (range); mean ± SD
UCG (n = 151) 0.76 (0.22 – 1.88)
0.81 ± 0.25 0.93 (0.19 – 1.50)
0.89 ± 0.21 < 0.001 (Sign Rank)
PCG (n = 174) 0.77 (0.27 – 2.00)
0.81 ± 0.24 0.95 (0.26 – 4.29)
0.94 ± 0.35 < 0.001 (Sign Rank)
Difference between UCG and PCG 0.496 (Wilcoxon Rank)
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Changes in BP
Both systolic and diastolic BP decreased significantly over the study period in both groups. The change in mean systolic blood pressure was significantly greater in the PCG than the UCG. The decrease in systolic BP was 5.37 mmHg ± 2.33 greater in the PCG. The difference between the PCG and UCG for diastolic BP failed to reach statistical significance. The changes in blood pressure over the six-month period are illustrated in Table 15.
Table 15: Changes in blood pressure between baseline and six months
BP readings Baseline Six months Reduction P
Systolic BP median (IQR); mean ± SD
UCG (n = 176) 138.3 (126.5 – 151.9)
140.07 ± 20.19 133.0 (92.0 – 245.0)
135.27 ± 20.66 4.61 ± 23.05
0.009 (Paired t-test)
PCG (n = 176) 141.0 (128.1 – 153.9)
141.87 ± 19.96 129.50 (120.8 - 144)
131.77 ± 16.75 9.97 ± 20.61
<0.001 (Paired t-test)
Difference between UCG and PCG
5.37 ± 2.33 0.022 (t-test)
Diastolic BP median (IQR); mean ± SD
UCG (n = 176) 83.5 (76.0 – 91.0)
83.22 ± 11.60 77.0 (71.0 – 86.0)
78.84 ± 11.24 4.22 ± 12.83
<0.001 (Paired t-test)
PCG (n = 176) 84.0 (76.3 – 91.0)
84.31 ± 11.04 81.0 (73.8 – 86.0)
80.21 ± 10.81 4.48 ± 12.38
<0.001 (Paired t-test
Difference between UCG and PCG
0.27 ± 1.34 0.843 (t-test)
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Changes in Health Beliefs and Attitudes
There were no significant changes in the health beliefs and attitudes of participants, except in the ‘confidence’ domain of BBQ. Although the ‘confidence’ of PCG participants increased more than that of UCG participants; the difference between groups was just short of reaching significance. The changes in scores on the various health belief and attitude domains of the BBQ over the six-month period are illustrated in Table 16.
Table 16: Changes to health beliefs and attitudes between baseline and six months
BBQ domain Baseline Six months P
Confidence median (IQR); mean ± SD
UCG (n = 161) 38.5 (34.0 – 42.0)
38.0 ± 4.91 39.5 (35.25 – 43.0)
38.79 ± 4.80 0.045 (Signed Rank)
PCG (n = 143) 37.0 (34.25 - 41)
37.14 ± 5.10 40 (36.0 – 42.0)
38.87 ± 4.41 <0.001 (Paired t-test)
Difference between UCG and PCG 0.053 (Wilcoxon Rank)
Concerns median (IQR); mean ± SD
UCG (n = 157) 14.0 (12.0 – 17.0)
14.50 ± 3.39 14.0 (12.0 – 16.0)
14.17 ± 3.23 0.449 (Paired t-test)
PCG (n = 142) 15.0 (13.0 – 16.0)
14.53 ± 3.17 14.0 (13.0 – 16.0)
14.42 ± 2.80 0.918 (Paired t-test)
Difference between UCG and PCG 0.660 (t-test)
BBQ domain Baseline Six months P
Satisfaction median (IQR); mean ± SD
UCG (n = 168) 14.0 (12.0 – 15.0) 12.98 ± 2.68
14.0 (12.0 – 15.0) 12.98 ± 2.40
0.811 (Paired t-test)
PCG (n = 171) 14.0 (12.0 – 15.0) 12.73 ± 2.84
14.0 (12.0 – 15.0) 12.92 ± 2.49
0.318 (Paired t-test)
Difference between UCG and PCG 0.538 (t-test)
Disappointment median (IQR); mean ± SD
UCG (n = 167) 7.0 (5.0 – 9.0) 7.45 ± 2.88
7.0 (5.0 – 8.0) 7.23 ± 2.61
0.480 (Paired t-test)
PCG (n = 166) 7.0 (5.0 – 9.0) 7.69 ± 2.72
7.0 (5.0 – 9.0) 7.57 ± 2.74
0.566 (Paired t-test)
Difference between UCG and PCG 0.981 (t-test)
Subgroup Analyses
A number of subgroup analyses were performed on patients:
I. who self-reported nonadherence on the Morisky scale (total score>0) at baseline;
II. whose BP (systolic and/or diastolic) was above the GP target at baseline
III. who self-reported nonadherence on the Moriskydiastolic) was above GP target at baseline.
Subgroup Analysis I: Patients Nonadherent at
Subgroup analyses were performed on patients who selfscore>0) at baseline.
Changes in adherence
Within the 74 UCG and 68 PCG participants also had Morisky scores recorded at six months, period (Figure 4).. A significant difference was detected between the groups (
Figure 4: Subgroup I: Changes in adherence rate according to Morisky
There was an improvement in the TABS adherence score UCG. The PCG demonstrated significant improvementmonths, but the differences in comparison to theadherence in this subgroup over the six
61.8
39.2
0
10
20
30
40
50
60
70
Became adherent
Pe
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subgroup analyses were performed on patients:
reported nonadherence on the Morisky scale (total score>0) at baseline;
whose BP (systolic and/or diastolic) was above the GP target at baseline; and
reported nonadherence on the Morisky scale (total score >0) and whose BP (systolic and/or diastolic) was above GP target at baseline.
onadherent at Baseline
Subgroup analyses were performed on patients who self-reported nonadherence on the Morisky
participants reporting nonadherence on the Morisky score at baseline and who also had Morisky scores recorded at six months, nearly 62% of PCG patients became adherent o
A significant difference was detected between the groups (χ² = 7.22, p=0.007).
in adherence rate according to Morisky scale from base
in the TABS adherence score in the PCG which was significantly greater than inUCG. The PCG demonstrated significant improvements in the Morisky total score and MedsIndex score at
in comparison to the UCG did not reach statistical significance.six-month period are illustrated in Table 17.
38.2
60.8
No change
Sub-group I(nonadherent by Morisky)
50
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reported nonadherence on the Morisky scale (total score>0) at baseline;
scale (total score >0) and whose BP (systolic and/or
reported nonadherence on the Morisky scale (total
reporting nonadherence on the Morisky score at baseline and who of PCG patients became adherent over the time
p=0.007).
from baseline to six months
which was significantly greater than in the Morisky total score and MedsIndex score at six
tatistical significance. The changes in
PCG
UCG
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Table 17: Changes in adherence between baseline and six months for patients nonadherent at baseline
Measure of adherence Baseline Six months P
Morisky total score median (IQR); mean ± SD
UCG (n = 74) 1 (1 - 2)
1.38 ± 0.69 1 (0 – 1)
0.76 ± 0.72 <0.001 (Sign Rank)
PCG (n = 68) 0 (0 - 1)
1.28 ±0.63 0 (0 – 1)
0.49 ± 0.74 <0.001 (Sign Rank)
Difference between UCG and PCG 0.082 (Wilcoxon Rank)
Measure of adherence Baseline Six months P
TABS adherence score median (IQR); mean ± SD
UCG (n = 73) 20.0 (19.0 – 20.0)
18.68 ± 2.58 19.0 (18.0 – 20.0)
18.68 ± 2.00 0.887 (Sign Rank)
PCG (n = 65) 19.0 (17.0 – 20.0)
17.73 ± 2.81 20.0 (18.0 – 20.0)
18.61 ± 2.13 0.027 (Sign Rank)
Difference between UCG and PCG 0.046 (Wilcoxon Rank)
TABS nonadherence score median (IQR); mean ± SD
UCG (n = 70) 9.0 (7.0 – 11.0)
8.95 ± 2.74 8.0 (6.0 - 9.8) 7.93 ± 2.47
0.109 (Sign Rank)
PCG (n = 61) 8.0 (6.0 – 11.0)
8.55 ± 2.95 8.0 (6.0 - 10.0)
8.05 ± 3.05 1.00 (Sign rank)
Difference between UCG and PCG 0.291 (Wilcoxon Rank)
TABS differential median (IQR); mean ±SD
UCG (n = 70) 10.0 (8.0 – 12.0)
9.73 ± 3.90 11.0 (9.0 – 13.0)
10.77 ± 3.62 0.072 (Paired t-test)
PCG (n = 61) 10.0 (6.0 – 12.0)
9.22 ± 4.01 12.0 (8.0 – 14.0 )
10.52 ± 3.91 0.117 (Paired t-test)
Difference between UCG and PCG 0.922 (t-test)
MedsIndex score for BP medicines median (IQR); mean ± SD
UCG (n = 57) 88.5 (64.8 – 96.0)
78.44 ± 22.52 83.0 (69.0 - 97.5)
79.55 ± 21.04 0.949 (Paired t-test)
PCG (n = 48) 81.0 (64.0 - 95.3)
77.12 ± 19.83 92.0 (70.0 – 99.0)
84.76 ± 16.86 0.032 (Paired t-test)
Difference between UCG and PCG 0.118 (t-test)
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Changes in BP
Both systolic and diastolic BP decreased significantly over the study period in the PCG. The differences between the PCG and UCG reached statistical significance for systolic BP. The decrease in systolic BP was 9.37 mmHg ± 3.57 greater for the PCG group. The changes in blood pressure over the six-month period are illustrated in Table 18.
Table 18: Changes to BP between baseline and six months for patients nonadherent at baseline
BP readings Baseline Six months Reduction P
Systolic BP median (IQR); mean ± SD
UCG (n = 75) 136.0 (126.0-148.5)
138.17 ± 20.21 133.0 (123.0 – 144.0)
134.21 ± 17.94 3.6 ± 21.22
0.146 (Paired t-test)
PCG (n = 68) 139.5 (129.0 -156.5)
141.75 ± 20.38 127.0 (116.5 – 140.0)
128.68 ± 15.26 12.97 ± 21.47
<0.001 (Paired t-test)
Difference between UCG and PCG
9.37 ± 3.57 0.010 (t-test)
BP readings Baseline Six months Reduction P
Diastolic BP median (IQR); mean ± SD
UCG (n = 75) 84.0 (78.0 – 90.0)
83.92 ± 11.75 79.0 (73.0 – 88.0)
80.55 ± 10.20 2.84 ± 10.85
0.026 (Paired t-test)
PCG (n = 68) 84.0 (74.0 - 94.5)
84.94 ± 12.38 80.0 (73.5 – 86.0)
79.54 ± 9.54 6.03 ± 12.33
< 0.000 (Paired t-test)
Difference between UCG and PCG
3.19 ± 1.94 0.102 (t-test)
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Subgroup Analysis II: Patients not achieving BP targets at baseline
Changes in adherence
The PCG demonstrated significant improvement in the Morisky total score and the MedsIndex score at six months, but the differences between the PCG and the UCG did not reach statistical significance. The changes in adherence in this subgroup over the six-month period are illustrated in Table 19.
Table 19: Changes in adherence between baseline and six months for patients not achieving target BP at baseline
Measure of adherence Baseline Six months p
Morisky total score median (IQR); mean ± SD
UCG (n = 120) 0 (0 – 1.0) 0.61 ± 0.86
0 (0 – 1.0) 0.43 ± 0.63
0.030 (Sign rank)
PCG (n = 109) 0 (0 – 1.0) 0.50 ± 0.69
0 (0 – 1.0) 0.33 ± 0.57
0.026 (Sign rank)
Difference between UCG and PCG 0.548 (Wilcoxon Rank)
TABS adherence score median (IQR); mean ± SD
UCG (n = 118) 20.0 (19.0 – 20.0)
19.02 ± 2.16 20.0 (19.0 – 20.0)
19.08 ± 1.74 0.650 (Paired t-test)
PCG (n = 106) 19.0 (18.0 – 20.0)
18.25 ± 2.92 20.0 (18.0 – 20.0)
18.90 ± 1.91 0.106 (Paired t-test)
Difference between UCG and PCG 0.389 (t-test)
TABS nonadherence score median (IQR); mean ±SD
UCG (n = 118) 8.0 (6.0 – 10.0)
8.29 ± 2.87 8.0 (6.0 – 9.0 )
7.61 ± 2.47 0.228 (Sign Rank)
PCG (n = 102) 8.0 (6.0 – 10.0)
7.98 ± 2.67 7.0 (5.0 – 10.0)
7.78 ± 3.11 0.444 (Sign Rank)
Difference between UCG and PCG 0.874 (Wilcoxon Rank)
Measure of adherence Baseline Six months P
TABS differential median (IQR); mean ± SD
UCG (n = 118) 11.0 (8.0 – 13.0)
10.72 ± 3.83 12.0 (10.0 – 14.0)
11.47 ± 3.32 0.070 (Paired t-test)
PCG (n = 102) 11.0 (8.0 – 13.0)
10.28 ± 3.88 12.0 (9.0 – 14.0)
11.15 ± 3.72 0.254 (Paired t-test)
Difference between UCG and PCG 0.668 (t-test)
MedsIndex score for BP medicines median (range); mean ± SD
UCG (n = 100) 90.5 (69.3 – 98.0)
81.78 ± 19.59 91.0 (72.0 – 99.0)
82.76 ± 20.10 0.477 (Paired t-test)
PCG (n = 91) 81.5 (67.8 – 94.3)
78.68 ± 18.48 91.5 (74.0 – 99.0)
84.94 ± 16.54 0.002 (Paired t-test)
Difference between UCG and PCG 0.116 (t-test)
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Changes in BP
Both systolic and diastolic BP decreased significantly over the study period in both groups. The difference of 7.14 mmHg ± 2.77 in systolic BP between the PCG and UCG was statistically significant. The changes in blood pressure over the six-month period are illustrated in Table 20.
Table 20: Changes in blood pressure between baseline and six months for patients not achieving target BP at baseline
BP readings Baseline Six months Reduction P
Systolic BP median (IQR); mean ± SD
UCG (n = 122) 144.0 (136.0 – 156.5)
147.62 ± 17.65 135.0 (123.8 – 150.3)
138.06 ± 20.47 9.18 ± 21.97 <0.001
(Paired t-Test)
PCG (n = 113) 148.0 (138.3 – 161.0)
149.99 ± 17.73 131.0 (121.5 – 144.0)
133.41 ± 16.13 16.32 ± 20.31 <0.001
(Paired t-Test)
Difference between UCG and PCG
7.14 ± 2.77 0.01
(t-Test)
Diastolic BP median (IQR); mean ± SD
UCG (n = 122) 87.0 (72.0 – 86.3)
86.89 ± 10.52 79.0 (69.3 – 98.0)
79.98 ± 11.22 6.61 ± 11.72 <0.001
(Paired t-Test)
PCG (n = 113) 88.0 (75.5 – 87.5)
88.32 ± 10.33 81.0 (67.8 – 94.3)
81.25 ± 10.02 7.17 ± 12.32 <0.001
(Paired t-Test)
Difference between UCG and PCG
0.55 ± 1.57 0.725
(t-Test)
Subgroup Analysis III: Patients nonadherent and not achieving BP targets at baseline
Subgroup analyses were also performed on patients who were nonadherentwhose BP (systolic and/or diastolic) was above target at baseline.
Changes in adherence
Within the 53 UCG and 44 PCG reporting nonadherence on the Morisky score and above GP target systolic and/or diastolic BP at baseline, 56.8% of PCG patients became adherent over the time period (Figure difference was detected between the groups (
Figure 5: Subgroup III: Changes in adherence rate according to Morisky
56.8
35.9
0
10
20
30
40
50
60
70
Became adherent
Pe
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Subgroup Analysis III: Patients nonadherent and not achieving BP targets at baseline
Subgroup analyses were also performed on patients who were nonadherent according to the Morisky scale and whose BP (systolic and/or diastolic) was above target at baseline.
Within the 53 UCG and 44 PCG reporting nonadherence on the Morisky score and above GP target systolic and/or e, 56.8% of PCG patients became adherent over the time period (Figure
difference was detected between the groups (χ² = 4.265, p=0.039).
in adherence rate according to Morisky scale from baseline to six months
43.2
35.9
64.2
Became adherent No change
Subgroup III (nonadherent by Morisky & BP above target)
55
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Subgroup Analysis III: Patients nonadherent and not achieving BP targets at baseline
according to the Morisky scale and
Within the 53 UCG and 44 PCG reporting nonadherence on the Morisky score and above GP target systolic and/or e, 56.8% of PCG patients became adherent over the time period (Figure 5). A significant
from baseline to six months
PCG
UCG
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The PCG demonstrated significant improvement in the Morisky total score, TABS adherence score and the MedsIndex score at six months, but the differences between the PCG and the UCG did not reach statistical significance. The changes in adherence in this subgroup over the six-month period are illustrated in Table 21.
Table 21: Changes in adherence between baseline and six months for patients not achieving target BP at baseline
Measure of adherence Baseline Six months P
Morisky total score median (IQR); mean ± SD
UCG (n = 53) 1.0 (1.0 -2.0) 1.41 ± 0.76
1.0 (0.0 -1.0) 0.77 ± 0.70
< 0.001 (Sign rank)
PCG (n = 44) 1 (1 – 1)
1.21 ± 0.53 0.0 (0.0 – 1.0)
0.48 ± 0.59 < 0.001 (Sign rank)
Difference between UCG and PCG 0.224 (Wilcoxon Rank)
TABS adherence score median (IQR); mean ± SD
UCG (n = 51) 19.0 (18.0 – 20.0)
19.0 ± 2.95 19.0 (18.0 – 20.0)
18.57 ± 2.18 0.506 (Sign rank)
PCG (n = 43) 18.0 (16.0 – 20.0)
17.37 ± 3.19 19.0 (18.0 – 20.0)
18.51 ± 2.21 0.043 (Sign rank)
Difference between UCG and PCG 0.063 (Wilcoxon Rank)
TABS nonadherence score median (IQR); mean ±SD
UCG (n = 53) 8.5 (7.0 – 11.0)
8.96 ± 2.74 8.0 (7.0 – 10.0 )
8.25 ± 2.45 0.093 (Sign Rank)
PCG (n = 40) 8.0 (5.25 – 10.0)
7.96 ± 2.81 7.5 (5.25 – 10.0)
8.20 ± 3.29 0.803 (Sign Rank)
Difference between UCG and PCG 0.262 (Wilcoxon Rank)
Measure of adherence Baseline Six months p
TABS differential median (IQR); mean ± SD
UCG (n = 51) 10.0 (7.0 – 12.0)
9.39 ± 4.24 11.0 (8.0 – 13.0)
10.35 ± 3.65 0.163 (Sign rank)
PCG (n = 40) 10.0 (6.0 – 13.0)
9.49 ± 4.26 10.5 (8.0 – 13.75)
10.30 ± 3.89 0.643 (Sign Rank)
Difference between UCG and PCG 0.612 (Wilcoxon Rank)
MedsIndex score for BP medicines median (range); mean ± SD
UCG (n = 42) 88.0 (63.5 – 96.0)
78.73 ± 21.88 83.0 (70.0 – 97.75)
78.88 ± 22.56 0.904 (Sign Rank)
PCG (n = 36) 80.0 (63.25 – 90.75)
75.19 ± 20.09 92 (75.0 – 99.75)
85.75 ± 16.81 0.013 (Sign Rank)
Difference between UCG and PCG 0.109 (Wilcoxon Rank)
Changes in BP
Both systolic and diastolic BP decreased significantly over the study period in both groups. The difference of mmHg ± 4.29 in systolic BP between the PCG and UCG was statistically significant. over the six-month period are illustrated in Table 22.
Table 22: Changes in blood pressure between baseline and six months for patients not achieving target BP at baseline
BP readings Baseline
Systolic BP mean ± SD
UCG (n = 53) 144.76
PCG (n = 44) 150.18
Difference between UCG and PCG
Diastolic BP mean ± SD
UCG (n = 53) 86.77
PCG (n = 4) 90.30
Difference between UCG and PCG
The changes in systolic BP across the whole and three sub
Figure 6: Reduction in systolic BP from baseline to six months
9.97
12.97
4.61
0
5
10
15
20
25
Whole group
Re
du
ctio
n in
me
an
sy
sto
lic
BP
(m
mH
g)
(PCG: n= 176; UCG: n=176) (PCG: n=68; UCG: n=75)
*
a siginficant reduction at p<0.001; b siginificant reduction at p<0.017;
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Both systolic and diastolic BP decreased significantly over the study period in both groups. The difference of in systolic BP between the PCG and UCG was statistically significant. The changes in
month period are illustrated in Table 22.
blood pressure between baseline and six months for patients not achieving target BP
Baseline Six months Reduction
144.76 ± 17.32 137.42 ± 17.80 7.35 ±
150.18 ± 18.40 129.89 ± 15.56 20.30
12.95
77 ± 9.68 81.53 ± 10.11 5.25
90.30 ± 12.11 81.14 ± 9.41 9.16 ± 12.
3.91
The changes in systolic BP across the whole and three subgroups are presented in Figure 6
from baseline to six months
12.97
16.32
20.3
3.6
9.18
Subgroup I Subgroup II Subgroup IIInonadherent
(PCG: n=68; UCG: n=75)
above target BP
(PCG: n=113; UCG: n=122)
nonadherent & above target BP
(PCG: n=44; UCG: n=53)
b
siginificant reduction at p<0.017; * nonsignificant
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Both systolic and diastolic BP decreased significantly over the study period in both groups. The difference of 12.95 The changes in blood pressure
blood pressure between baseline and six months for patients not achieving target BP
Reduction P
± 21.39 0.016 (Paired t-Test)
20.30 ± 20.61 <0.001 (Paired t-Test)
12.95 ± 4.29 0.003 (t-Test)
5.25 ± 9.57 <0.001 (Paired t-Test)
± 12.36 <0.001 (Paired t-Test)
± 2.23 0.082 (t-Test)
igure 6.
20.3
7.35
Subgroup III
PCG
UCG
nonadherent & above target BP
(PCG: n=44; UCG: n=53)
b
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Hidden Control Group
HCG patients were matched to UCG patients by their identification (nonadherent, nonpersistent or both) by MedeMineCVD. At baseline, no statistically significant differences in the MPRs (lowest, highest or average) were found between the UCG and HCG group (Table 23).
At the six-month follow-up, there was no statistically significant difference in the lowest MedsIndex scores (as calculated for all antihypertensive medicines the patients were taking) between the UCG and HCG patients as shown in Table 24.
Table 24: Difference between mean MedsIndex scores calculated for UCG and HCG patients
Mean MedsIndex - UCG Mean MedsIndex - HCG P
Lowest MedsIndex at six months 82.32 ± 19.59 80.97 ± 19.45 0.545
Further, no statistically significant differences in the mean change of any of the MPRs used to calculate adherence between the UCG and the HCG were found as shown in Table 25.
Table 25: Differences between MPRs from baseline to six-months calculated for UCG and HCG patients
MPR value used UCG (mean) HCG (mean) P
Lowest MPR at six months 0.89 ± 0.21 0.85 ± 0.26 0.208
Highest MPR at six months 1.01 ± 0.31 0.99 ± 0.39 0.699
Average MPR at six months 0.95 ± 0.23 0.92 ± 0.28 0.391
Difference between:
Lowest MPR at six months and baseline 0.105 0.112 0.841
Highest MPR six months and baseline 0.030 0.090 0.444
Average MPR six months and baseline 0.071 0.100 0.269
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Discussion
The aim of the study was to test an intervention to assist community pharmacists to improve patient adherence and/or persistence with antihypertensive medications (primary outcome measure). The expectation was that improving adherence would lead to improved blood pressure control (secondary outcome).
Haynes et al. (2008) highlighted the need for examining the effectiveness of adherence interventions involving allied health professionals in regard not only to adherence, but also to their clinical benefit, as improving medication adherence will not necessarily translate into clinical benefits for the patient. Hence, interventions should also be assessed in terms of their effects on clinically important outcomes and feasibility in usual practice settings.
Effects on adherence
The proportion of participants in each group who were identified to be adherent by the Morisky score increased in both groups from baseline to six months; however, while some individuals achieved improved adherence, others became nonadherent and this observation did not differ significantly between the groups. It is unclear why adherence scores became worse for some people, particularly in the PCG. Although the proportion of patients who became adherent over the course of the study was not significantly different between groups overall, significant differences in favour of the PCG were detected for both the subgroups in which all participants were nonadherent according to the Morisky score at baseline.
Significant improvements in adherence were seen in the PCG over the six months of the trial in several measures of adherence – the Morisky score, MedsIndex, and the MPR. Improvements in the Morisky score and the MPR were also seen in the UCG, but to a lesser extent. The UCG demonstrated a significant reduction in the TABS nonadherence score, which was not shown by the PCG. Being part of the trial may, in itself, have influenced the adherent behaviour of the UCG patients, either through the Hawthorne effect or simply by raising their awareness of the importance of blood pressure control. It is likely that participants may have answered questions in the Morisky scale and TABS in a socially acceptable manner, especially at the six-month visit. Comparisons were made with the HCG to check for any Hawthorne effect using MedsIndex scores and MPRs, both of which have inherent limitations as adherence measures. These were, however, the only measures for which data were available given the nature of the HCG. While no differences were found between the between the HCG and UCG on MedsIndex or MPR, indicating that there was minimal ‘Hawthorne effect’ on persistence/adherence per se, pharmacist contact might have had influences on other factors (e.g. medication knowledge, knowledge about BP) in the UCG.
No significant differences between the groups were demonstrated for any of the adherence measures. This is consistent with the results of a review and meta-analysis looking at the sensitivity of patient outcomes to pharmacist interventions in hypertension, which concluded that adherence was a nonsensitive measure
31. This
may reflect inadequacy of the adherence measures for the purpose.
Another possibility for seeing improvement in both groups is that an external influence may have impacted upon adherence during the course of the trial (e.g. the Mirixa program or adult education on hypertension conducted by consumer groups). This cannot be confirmed, as no data about other potential confounders were collected. The possibility is supported, however, by the fact that no statistically significant differences in the MedsIndex scores or MPRs were detected between the UCG and HCG patients, even though the MPR increased in both groups over the trial period.
Given that a high proportion of participants were adherent at baseline (according to the various adherence measures and anecdotal feedback from pharmacists) a subgroup analysis was performed on those patients who were nonadherent according to the Morisky score, in order to explore whether this was a likely explanation. The Morisky score was chosen over the other measures as it is the most widely recognised self-reported adherence measure and may be suitable to use as an additional screen for eligible participants to receive the service if it were to be implemented in the future. This analysis showed a significant improvement in the PCG over the UCG in the TABS adherence score. The PCG demonstrated significant improvements in the Morisky score and MedsIndex score at six months and the UCG demonstrated significant improvement on the Morisky score only. Differences between the groups were not significant for MedsIndex or Morisky score at the predetermined p <0.05 level, although the difference in Morisky score was significant at the p < 0.1 level, suggesting that a larger sample size may demonstrate significance, given that the subgroup contained around 70 per group rather than the calculated 182.
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A second subgroup analysis was undertaken on patients who were above their target blood pressure at baseline to determine if this could potentially be a useful eligibility criterion for receiving the service. Again, the PCG group demonstrated significant improvement in Morisky score and the MedsIndex score at six months, but the differences were not significant when compared to the UCG. (Sample size for this subgroup was 90-120.)
Analysis of the group who were both nonadherent according to the Morisky score and above target BP at baseline (sample size around 50 per group) showed a significant difference between groups in regard to the proportion of participants who became adherent over the course of the trial, with a higher proportion of the PCG group becoming adherent. In addition, the PCG demonstrated significant improvements in Morisky score, TABS adherence and MedsIndex score at six months, the difference in MedsIndex score being significant (p = 0.046) when compared to the UCG. (Sample size for this subgroup was 36-53).
Effects on blood pressure
Both systolic and diastolic BP decreased significantly over the study period in both groups. The change in mean systolic blood pressure was significantly greater in PCG than UCG patients. Difference in diastolic blood pressure between PCG and UCG patients was not statistically significant. This is consistent with other studies; a review and meta-analysis of patient outcomes resulting from pharmacist interventions in hypertension concluded that systolic blood pressure was sensitive to intervention, but that diastolic blood pressure was not
31.
The fact that systolic blood pressure was significantly reduced suggests that the intervention is valuable in terms of health outcomes, as a decrease in systolic blood pressure of 10 mmHg was achieved in the PCG.
Subgroup analysis of the group who were nonadherent at baseline also showed a decrease in systolic blood pressure in the PCG group of the order of 13 mmHg, which was significantly greater than the drop in the UCG. A reduction of 12 to 13 mmHg over four years of follow-up has been shown to reduce the incidence of heart attacks, strokes and deaths from cardiovascular disease
7.
Subgroup analysis of participants who were above target blood pressure at baseline showed a decrease in systolic blood pressure in the PCG group of the order of 16 mmHg, and 20mmHg for the group who were also nonadherent according to Morisky scale. These reductions were significantly greater than the drop in the UCG and suggest that patients with blood pressure above target may achieve even greater long-term health benefits from the intervention.
Even though improvement in adherence was not demonstrated, the intervention has shown potential to reduce cardiovascular risk. As mentioned before, it may be that the adherence measures are not sensitive enough to detect change. Regardless of that, the intervention has resulted in behaviour change that has improved blood pressure control. Feedback from consumers and pharmacists during Phase 4 focus groups and interviews was that the two most important components of the intervention were monitoring their own BP regularly and the education from the pharmacists, which empowered them to have greater understanding of and input into their BP control.
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Results – Economic evaluation
Analysis of cost
Pharmacy based costs
Cost analysis of the Pharmacy Care Group (PCG) vs the Usual Care Group (UCG) over six months is illustrated in Table 26.
1. Set-up cost – fixed cost
Set-up costs include installation of related new computer software and interface, screen (or similar) to ensure private space, and other administrative materials and support. The cost is drawn from similar previous program set-up costs paid by the Pharmacy Guild
125.
2. Training cost – fixed cost
A one-day training course was delivered to 18 pharmacists face-to-face, and the same training manual was put online to train another 39 pharmacists. Total training cost would include training manual development, communication with participants, lecture delivery, venue hire, teaching equipment, lunch, morning and afternoon tea, administrative support and other miscellaneous expenses
129-142. Due to the fact that the training course was
developed and delivered by the research team at an unusually low cost in this trial, the actual cost of this training cannot represent that of a course that would be normally developed and delivered. Since economic evaluation needs to use the opportunity cost to reflect real resource required, the total cost was estimated based on similar courses developed and delivered in previous studies through the Pharmacy Guild, which is estimated to be $17,000, i.e., $82.13 per patient in the PCG
129,132,137.
3. Pharmacist service time – variable cost
The amount of time pharmacists need to deliver the service during the intervention can be captured via the three-month follow-up visit. This is because the three-month appointments were only conducted by the PCG pharmacists and little research data were collected at this appointment compared to at baseline and completion, i.e. most of the interview time was spent conducting the intervention. The average pharmacist service time (excluding time for collecting research data) for each patient was 22.9±12.4 minutes for providing the service specified in the intervention package.
The wage rate for pharmacists was drawn from the 2009 Community and Hospital Pharmacists’ Remuneration Survey Report
143. The highest rate was chosen from various hourly rates across states and localities, with 40% on-
cost. AU$52.53 per hour was used as the cost of pharmacists’ time in the economic model.
4. Omitted costs
Due to insignificance in the total cost, the shared operating cost of using computer systems, software already in use and the maintenance of the pharmacy for delivering the service were omitted in calculating pharmacist costs.
Patient costs
1. Blood Pressure (BP) monitors
The purchase cost of the Omron HEM-790IT BP monitor was $115 per unit excluding GST. As this model was not yet available in Australia, we had no retail value. The monitor was assumed to have a life span of 3.3 years and the cost of the monitor would be spread evenly across three years (i.e., AU$38.30 per year) when calculating the cost of the monitor on the 10-year base in the economic model.
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2. Medication
Patients’ medication histories were captured by MedeMineCVD. All medicines dispensed to the patient in the six-month period of treating hypertension were identified by four pharmacists in the research team. The price of each medicine was taken from the Schedule of Pharmaceutical Benefits via the PBS website (www.pbs.gov.au). The MedsIndex was used to adjust the amount of medicine dispensed to each patient in the two groups during the six-month follow-up period. The average medication dispensing cost, including both patient co-payment and PBS subsidy, in six months was AU$202.76 to the PCG patient and AU$210.57 to the UCG patient. PCG patients had slightly lower medication cost than UCG patients, but the difference was not statistically significant (p=0.516 - 2-tailed).
3. General Practitioner (GP) visits
Information regarding hypertension-related GP visits during past six months was collected in the six-month follow-up survey. The average number of visits was 2.42 for PCG patients and 2.28 for UCG patients. The cost of each visit included the out-of-pocket cost to the patient and the standard physician consultation fee to Medicare. Out-of-pocket cost to the patient included co-payment, travel expenses and other related costs. The physician consultation fee paid by Medicare was AU$34.30 per visit
144. The average cost of GP visits in six months was AU$121.60 for
PCG patients and AU$113.42 for UCG patients. Because PCG patients had a slightly higher number of GP visits than UCG patients, the average cost was also greater.
4. Emergency department visits
The information regarding hypertension-related Emergency Department (ED) visits during past six months was also collected in the six-month follow-up survey. Similarly to the cost of a GP visit, the cost of an ED visit included the out-of-pocket cost to the patient and the emergency service cost to the hospital. The out-of-pocket cost included co-payment, travel expenses and other related costs. The cost of the ED visit was derived from the average of hypertension-related ED visits (Heart failure & Shock, Coronary Atherosclerosis, Hypertension, Unstable Angina, Syncope & Collapse, Stroke) which was AU$407 per visit
145. The number of ED visits in the six months was 0.06
for PCG patients and 0.07 for UCG patients. The average cost of ED visits in the six-month period was AU$28.17 for PCG patients and AU$31.90 for UCG patients. PCG patients had slightly fewer ED visits and, therefore, lower cost than UCG patients.
5. Hospital stay
Hypertension-related inpatient hospital stays during the past six months were asked in the six-month follow-up survey. The cost of inpatient stay included the out-of-pocket cost to the patient and the inpatient cost to the hospital. The out-of-pocket cost included co-payment, travel expenses and other related costs. The cost of inpatient stay was calculated from the average cost of hypertension-related inpatient hospital stay (Heart failure & Shock, Coronary Atherosclerosis, Hypertension, Unstable Angina, Syncope & Collapse, Stroke) which was AU$5,356 per stay
145. The number of inpatient stays was 0.05 for PCG patients and 0.06 for UCG patients. The average cost of
hospital stay in the six-month period was AU$260.4 for PCG patients and AU$349.5 for UCG patients. PCG patients had slightly fewer hospital stays and, therefore, lower costs than UCG patients.
6. Omitted costs
Insignificant indirect costs to the patient were omitted. For example, the productivity loss due to emergency visits and inpatient hospital stays were omitted because most of participants in this trial were retired and had no work-related income loss.
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Table 26: Cost analysis of PCG and UCG for six months (Australian dollars, 2009)
Notes: 1. Set-up cost is estimated as $1400 for one pharmacy, divided by 6 patients (i.e., average number of patients
per PCG pharmacy), and amortised to 3 years. Setup cost is the initial investment to provide a specific service, based on assumption of well-equipped pharmacies.
Components of the setup cost include:
i. ‘FRED Dispense®’, pharmacy dispensing program (a pre-requisite for MedeMineCVD; assume shared cost of
$100).
ii. MedeMineCVD, software to identify patients who are using or have used antihypertensive medicines in the past
(provided for free in the research, assume licence fee $100 per site).
iii. Cost for setting up or modifying a private counselling area within the pharmacy. (This was included in the $500
paid to each pharmacy in the project, but may vary from $0 to $500 e.g., a table/desk, two chairs, one screen,
signage, a power point –assume $100) NOTE: Most community pharmacies have QCPP accreditation, which
requires a private counselling area, which would be used for multiple services.
iv. Pharmacists training time either face-to-face or online. Assume 1 (or 2) pharmacist(s) for one half-day training.
Time cost to the participating pharmacist is estimated to be $250 (or $500), including salary and travel expense.
v. Administrative overheads associated with participating in the project and preparing for and organising related
activities. Assume pharmacy manager/pharmacist spent 14 hours (two working days) in total. Cost is estimated
to be $700 (i.e., $50*14)
vi. BP monitor for pharmacy. Cost is $115
vii. Other small items and fees: IT related costs, communications, meetings…etc, assume $100 in total.
With reference to other Pharmacy Guild projects like PMP, the set-up cost is estimated as around $1, 400 per pharmacy. 2. Training program setup and delivery cost was estimated to be AU$17,000
60-62, divided by total 207 patients in
PCG and amortised to 3 years. 3. Pharmacist service time cost for the intervention was based on time spent for the intervention (mean 22.9
±12.4 minutes, i.e., time for collecting research data has been excluded); salary information used was that published by APESMA
63 together with 40% on-cost. Average hourly rate was $52.53 (including on-cost). It was
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assumed that pharmacists provided service every three months. For the first appointment, pharmacists spent more time on educating patients, which would cost $60.10 on average in the first six-month period, and $40.10 for any other period of six months.
4. BP monitor cost was not retail cost and was GST exempt. Model number is Omron HEM-790IT. Price was $115, amortised to 3 years with annual cost of $38.30. For six months, the cost was $19.17.
5. Unit costs of medicines were from PBS website: www.pbs.gov.au. MedsIndex was used to adjust the amount of medicine dispensed to each patient.
6. GP cost was the sum of the patient’s out-of-pocket expenses and provider cost. The average provider cost was $34.30, according to the Medicare Benefits Schedule
64.
7. ED visit cost was the sum of the patient’s out-of-pocket expenses and provider cost. The average provider cost was $407, according to National Hospital Cost Data Collection round 12
65.
8. Inpatient stay cost was the sum of patient’s out-of-pocket expenses and provider cost. The average provider cost was $5,356 according to National Hospital Cost Data Collection round 12
65.
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Analysis of effectiveness
The changes in utility scores for patient quality of life, as measured by AQoL8 over the six-month period, are illustrated in Table 27.
Table 27: AQoL8 utility scores generated from Pharmacy Care Group (PCG) and Usual Care Group (UCG)
The quality of life utility scores were identical in the PCG and the UCG at baseline. At the six-month follow-up, the utility score of the PCG had decreased by 0.1 and the utility score of the UCG had increased by 0.1. The differences were not statistically significant either within or between groups. Therefore, the average score (0.71) of the four scores was used for adjusting the life-years (LYs) gained in the economic model.
There have been many attempts to model the life-years gained from improved blood pressure control121-123,146
Sesso et al. (2003) modelled life-years gained from lowering blood pressure and extending life expectancy based on a Markov Model of cardiovascular events. Based on their findings, a reduction of systolic blood pressure from 160 to 140 mmHg for men with hypertension alone can result in 1.37 life-year gain (1.42 if having both hypertension and diabetes). For women, the gain is 2.17 (2.26 if having both hypertension and diabetes). A reduction of systolic blood pressure from 150 mmHg to 130 mmHg for men with hypertension alone can result in 1.45 life-year gain (1.53 if having both hypertension and diabetes) and for women the gain is 2.19 (2.38 if having both hypertension and diabetes). Moreover, they found that the relationship between reduction in blood pressure and life-years gained is likely to be linear and the magnitude of the reduction has more impact on life-year gain than the starting point of lowering the blood pressure. The economic model in this study is built on these findings. The estimations of life-year gain and related cost in the 10-year period between the PCG and the UCG are illustrated in Table 28.
Table 28: Results of cost-effectiveness analysis for PCG and UCG (Australian dollars, 2009)
PCG UCG Incremental
1 Year scenario
Discounted total cost $1469.54 $1410.74 $58.80
Discounted QALYs 0.0549 0.0456 0.0093
Incremental cost per QALY - - $6,322.58
10 years scenario
Discounted total cost $13,333-99 $12,957.61 $376.38
Discounted QALYs 0.5491 0.4556 0.0935
Incremental cost per QALY - - $4,025.45
Note: 1. Discount rate is 5% 2. Inflation rate is 3%
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Analysis of cost-effectiveness
The expected life-year gain for each patient in the PCG and the UCG was calculated based on age of the patient, gender, baseline systolic blood pressure, six-month systolic blood pressure and whether the patient had diabetes. The life-year gain was then adjusted by the utility score of 0.71 to become QALYs gained. The QALYs gained each year is assumed to be equal in each year during the 10-year period. It is further discounted by 5% to the baseline year and added to become total life-years gained over the 10-year period. The results of QALYs gained for one year and 10 years are reported in Table 27. The costs for the PCG and the UCG were calculated and compared using a similar process, but with 3% inflation each year forward. As shown in Table 27, the incremental cost per QALY gained is AU$6,322.58 for one year and AU$4,025.45 for the 10-year period.
The findings from this section have provided an answer for our research question: Can the proposed intervention package service, compared to usual care, generate more benefit at a cost (i.e., the Incremental Cost-Effectiveness Ratio, ICER) that is acceptable to the Australian society? The answer is ‘Yes’. The PCG intervention can be considered as highly cost-effective when comparing the cost of producing additional gain (i.e., QALY) of AU$6,322.58 for for one year and AU$4,025.45 for 10 years to the implicit gold standard used in Australia of AU$70,000 per QALY gained. Further, the sensitivity analysis (Table 28) performed for each of the key parameters has shown the robustness of the cost-effectiveness of this intervention. The range of cost per QALY gained is from AU$4,524.80 to AU$7,527.29.
Table 28: Sensitivity analysis of cost-effectiveness between PCG and UCG (Australian dollars, 2009)
Cost per QALY gained
Base Case
10 years $4,025.45
Medication cost
-20% $4,332.98 +20% $3,719.11
GP visit cost
-20% $3,703.78 +20% $4,348.31
ED visit cost
-20% $4,172.63 +20% $3,879.46
Inpatient cost
-20% $7,527.29 +20% $524.80
AQoL8 utility
-20% $5,032.56 +20% $3,355.04
Discount rate
0% $4,971.88
10% $3,356.65
The threshold analysis (Table 29) provides information on the maximum setup cost that the intervention can still be considered as cost-effective based on threshold A ($50,000) and threshold B ($70,000). For threshold of $50,000, the setup cost must not exceed $9,823 and for threshold of $70,000 the setup cost cannot exceed $13,487 if the intervention is considered to be cost-effective.
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Table 29: Threshold Analysis
Set up cost Cost per QALY in first year Cost per QALY in 10 years
$500 $2,010.91 $96.05
$1,400 $6,332.58 $4,025.45
$9,822.60 - $50,000
Threshold $13,486.80 - $70,000
Summary
The economic evaluation in this trial has estimated and compared both cost and QALYs gained due to the intervention between the PCG and the comparator (UCG). The ICER has demonstrated that the intervention is highly cost-effective compared to usual care. In this trial, the cost is AU$6,322.58 per QALY for the one-year scenario and AU$4,025.45 per QALY for the ten-year scenario, which is considered highly cost-effective when compared to the gold standard of AUS$70,000 per QALY gained. Due to the fact that setup cost can impact on the cost-effectiveness of this intervention if it is to be rolled out nationally, a further threshold analysis shows the maximum setup cost should be kept under $$9,823 (at threshold of $50,000) or $13,487 (at threshold $70,000).
Results – Business Case evaluation
Part I: Evaluation based on quantitative data
1. Are the trial intervention services performed by community pharmacists cost-effective in hypertension/CVD prevention and management?
It has been shown in the Economic Evaluation section that the intervention service investigated in this trial is cost-effective, relative to usual care. This provides a sound foundation that community pharmacists’ aid can be an important intervention for at-risk patients to obtain a better understanding of the meaning and importance of blood pressure, to educate patients how to monitor blood pressure at home, and to help patients lowering blood pressure via adhering to taking medicine.
2. What is the cost to the pharmacy for setting up this service?
Set-up cost is the initial investment to provide a specific service; the setup cost includes: (1) shared cost for ‘FRED Dispense
®’; (2) MedeMineCVD, software to identify patients who are using or have used antihypertensive
medicines in the past; (3) Cost for setting up a private counselling area within the pharmacy; (4) Pharmacists’ training time cost either face-to-face or online; (5) Administrative overheads associated with participating in the project and preparing for and organising related activities; (6) BP monitor for pharmacy; (7) other small items and fees; IT related costs, communications, meetings…etc. The set-up cost is estimated as around $1,400 per pharmacy. (See Notes to Table 26 for details)
3. What is the cost to the pharmacy for providing this service?
The cost of providing the service is mainly the time spent by the pharmacist to deliver the service to the patient. The service during the trial on average took 45 minutes for the initial visit and 23 minutes for the follow-up visits. Thus, the cost per visit is around $25 to the pharmacy.
The participants in the intervention group (PCG) were asked about their willingness to pay for a blood pressure control enhancement service. At the baseline visit, 145 out of 207 (70%) participants answered this question. After eliminating three outliers (their answers were larger than three standard deviations from the mean), the willingness to pay for this enhancement service was AU$17.40 (mean), AU$10 (median), and the most frequently reported value was AU$0 (mode). At the six-month follow-up visit, the same group of participants were asked about their
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willingness to pay for this new service they had experienced. 115 out of 178 (64.6%) participants answered this question. After eliminating five outliers, willingness to pay had increased to AU$18.89 (mean), AU$20 (median), and the most frequently reported value was AU$20. There was no statistically significant difference between the mean values at the two time points. However, the median and mode values changed dramatically: the median increased from AU$10 to AU$20 and the mode increased from AU$0 to AU$20). Although, after experiencing the service, the consumers’ most often reported willingness to pay was AU$20, the total cost of providing this service is higher than that figure. Consumers’ willingness to pay for this service can recover the variable cost. That is, the willingness to pay is equivalent to the pharmacists’ time cost (i.e., AU$52.5 * 23 minutes/60 minutes=AU$20.12). The fixed cost of providing this service remains to be covered via other sources of funding, presumably by the individual pharmacy. The changes in willingness to pay and other business case statistics are presented in Table 30.
Regarding consumer satisfaction, the satisfaction of PCG patients at the six-month follow-up visit increased slightly from 6.7 to 6.8. The median and mode are all 7 (perfectly satisfied) at baseline and at the six-month follow-up. Since satisfaction at baseline is already high, the room for increase in satisfaction is very limited. Although the improvement is not statistically significant, the new service tends to have some positive impact on customers’ satisfaction with the pharmacy. Regarding whether the new service would increase business for the pharmacy, the new intervention service has not resulted in significantly more business to the pharmacy in the six-month period. The frequencies of shopping and spending at the pharmacy each time are very similar between the baseline and the six-month follow-up. Patients in the PCG shopped at the pharmacy around every two weeks. The mean spending per visit seems somewhat inflated when compared to usual spending habits of consumers. A likely explanation may be misinterpretation of the question by the consumers. However, as the two figures at baseline and six-month follow-up are very similar, it can be assumed that the misinterpretation occurred at both stages and, therefore, the difference between the two points in time, which is not statistically significant, is still valid.
It may be that the questions about spending were viewed as sensitive by participants, as they may indicate the patient’s financial status. As the results show, 90% of participants answered the question of frequency of shopping at baseline and 77.3% at the 6-month follow-up; however, only 83.1% answered the question of spending at baseline and 66.7% at the six-month follow-up.
4. Who should pay for the service and how should it be financed?
Willingness to pay normally reflects the benefits the consumer believes they could receive. In addition to the benefit to the patient, this new pharmacist service could be expected to produce extra benefits to the wider community. This extra benefit is the so-called “positive externality” to the market of this new pharmacist service
147. The
consumer may not be aware of the extra benefit to the wider community, such as savings to the health system. As a result, the market price of the new pharmacist service, based on consumer’s willingness to pay, would have resulted in consumers to underutilising this new service. In other words, there would be less consumer demand for this service than society would ideally desire. Estimation of these extra benefits to the wider community is difficult but can be obtained from practitioners who are aware of such benefits, such as pharmacists and GPs. This information was collected through focus groups and interviews with pharmacists and GPs after completion of the trial.
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Part 2: Evaluation based on qualitative data
Although the new intervention service has not increased business to the pharmacy according to the quantitative data, some positive views were revealed in the qualitative data collected via focus group discussions and interviews with pharmacists and GPs. The following examples highlight how some of these practitioners perceive the potential benefits of this new service to themselves and to the Australian health care system. A few quotes also indicate issues regarding financing and the difficulty in promoting the new service to the “under-users” who are at risk but lack of the awareness of their own health risk.
Perceived benefits to the pharmacy
1. This intervention was perceived as being able to increase a pharmacy’s competitive advantage by attracting patients who value this new service.
We’ve got a lot of competition, cheaper pharmacies, and I think they’ll always come back to me in these particular cases.” (P5)
“Definitely, I guess the bleeding obvious one is if you improve someone’s compliance, they're going to fill more scripts (at your pharmacy). That's the bleeding bottom-line, dollar-grabbing pharmacy one.” (P2)
2. This new service was perceived as being able to increase pharmacists’ dignity and satisfaction with their work.
“I think that they developed a new respect for the pharmacist in terms of understanding that we’re not just a supply tool and that we do have knowledge and that we can be part of their team in helping them attain their goals”. (P10)
“If you're looking at the professional side of it, it’s a hell of a lot more satisfying to do than sticking a label on a box.” (P2)
Perceived benefits to the GP
Some GPs perceived that this new service would assist GPs to routinely monitor patients at risk, as these patients will seek the GP’s help when their blood pressure is too high. There was also recognition and appreciation for this level of division of labour and inter-disciplinary team work between pharmacist and GP.
“…if we’re helping more people get their blood pressure under control then that’s less time they’re going to be sent back to their doctor because their blood pressures are quite high and things like that.” (P3)
“Look, I think if it was an established service and you were happy that your patient went off in one month and had their blood pressure checked with the chemist and talked to them about their medication, and on the understanding they get back to you with any problems, then yeah, I’d be probably happier. I would always now, when I start a patient on a blood pressure medication, I always get them back in a month. If the pharmacy was taking over that role I certainly wouldn’t have a problem with it. I guess the only thing is then you’d certainly want some sort of faxed report that that had been done so that you know it’s been done.” (GP1)
Other perceived benefits to the wider society
1. Increased work force productivity
“There certainly are benefits in the wider community for that, if their blood pressure is controlled who’s to say they can't work for a further two to three years and therefore Mr Rudd would be much happier with us all retiring at 70 rather than 65 in the near future. … So there will be certainly those benefits, but putting a figure on it? I'm glad it’s someone else's responsibility.” (P2)
2. Reduced cost to the Australian health care system:
“Well potentially it would reduce health care costs, hospital-related visits and stuff like that if more people can keep their blood pressure under control. (P3)
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Perceived issues:
1. Who should finance the service?
Some pharmacists perceived that the funding of this service should not rely only on the patient’s willingness pay, but that the government also has a role in this respect.
“I think the community pharmacy would require funding from the government to roll out this type of service on a greater scale. But there’s certainly a lot of benefit to be gained from this.” (P7)
2. How to target the under-users who are at health risk but not aware of their risk? While this invention will help patients at risk who have health awareness, some practitioners expressed their concern for those people who are not aware of their health issues and felt that this new service would likely “miss the target”.
“Can I see any benefits? The real people that we need to be attacking are these people who don’t see themselves as having a health problem. Most of the people that do these trials are, if I may say, a little bit medically neurotic and love this attention and the people who don’t like doctors and don’t really think much of their health, who we really should be attacking, get missed.” (GP2)
Summary
In summary, the business case has investigated the set-up cost of well-equipped pharmacies and willingness to pay of the aged patients. The set-up cost should be considered carefully if the new service is to be rolled out for less-equipped pharmacies in the future. Patients are willing to pay around AU$20 for the new service and the remaining uncovered cost is appropriate to be subsidised by the government on the grounds of positive externality exist to the wider society in Australia.
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Phase 4 Stakeholders Post-trial Focus Groups and Interviews
Aim
The aims of this qualitative study were:
• to assess stakeholders’ (consumers, pharmacists and GPs) experiences and satisfaction with the pharmacy services provided during the HAPPY Trial; and
• to assess if and how the service helped consumers optimise their BP medication use and meet BP targets.
Methods
Pharmacists involved in the PCG were approached by a researcher to participate in a focus group or interview, and to provide Expression of Interest (EOI) letters to their patients enrolled in the trial (Appendix 25). Patients who completed and returned an EOI were then contacted by the researcher. Patients, if willing, also supplied details of their GPs, who were also contacted by a researcher regarding potential participation in the project evaluation. All potential participants received an explanatory statement (Appendices 26-28).
Separate focus groups were held for consumers and pharmacists. Telephone interviews were conducted with members of all three groups of stakeholders. Individuals were given the option of a telephone interview or attending a focus group.
Inclusion criteria
Any consumer, pharmacist or GP associated with the PCG of the trial was eligible.
Procedure
Focus groups and telephone interviews were conducted by a researcher with experience in conducting qualitative research.
Focus groups and telephone interviews were audio-recorded and transcribed verbatim. Supplementary notes were taken by an observer present at the focus groups.
For each group, a separate topic guide was used for focus groups and interviews (Appendices 29-31). The guides covered areas of the participants’ experiences during the HAPPY trial, especially with regard to recruitment, implementation, most and least useful aspects of the service, GP interaction and any recommendations for the future roll-out of the service.
Ethics
This study was approved by the Monash University Human Research Ethics Committee (MUHREC). Signed informed consent was obtained from each participant prior to interview or focus group participation (Appendices 32-34).
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Results
Twelve pharmacists, 13 consumers and three general practitioners participated in focus groups or telephone interviews. The distribution of participants across states and PhARIAs is detailed in Table 31.
Table 31: Distribution of focus group and telephone interview participants
Pharmacists Consumers GPs
Focus group 8 4 -
Telephone interview 4 9 3
Total 12 13 3
Tasmania 2 2 -
Victoria 8 8 3
Western Australia 2 3 -
PhARIA 1 6 10 1
PhARIA 2 3 1 2
PhARIA 3 1 1 -
PhARIA 4 1 - -
PhARIA 5 - -
PhARIA 6 1 1
The consumers represented nine pharmacies and the pharmacists 11 pharmacies.
The main themes identified from the focus groups and interviews are listed below. Supporting quotes from participants or observer notes are given as evidence for the emergent themes. Pharmacists’ quotes can be identified by the prefix letter ‘P’, consumers’ by ‘C’ and general practitioners’ by ‘GP’.
Pharmacist Training
Training provided to pharmacists was well received overall. Most of those who completed the training online or via CD-ROM thought that such training delivery formats were suitable and equipped them well to deliver the service. However, some would have preferred to attend a face-to-face session, if circumstances had allowed. Motivational interviewing was recognised as an area which required more attention.
“But generally speaking, the online training was fine; I found it helped me a lot.” P11
“I used the CD as well, which was pretty damn good actually.” P9
“We did it mostly by CD, which was fine. It was a good base and I guess this was generally more a refresher for us in a lot of ways. It’s more the practical side of the actual training of the relationship with the patient and what applies to them [that was missing], so that’s a lot of the hands-on or the one-to-one.” P3
“I think the motivational interviewing part was the part that freaks most people out, and it certainly did me, and is the part that we wouldn’t have explored a lot. I would say 90% of the people who were doing the trial, that would have been the part that was the newest and most unfamiliar and the part, I guess, that out of all of it needed more addressing. But certainly the other parts were fine.” P2
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Recruitment of patients
Most pharmacists commented that some of the participating patients appeared to have good adherence to their antihypertensive medications even at baseline. It was also thought that the mass mail-out of recruitment letters to patients using MedeMineCVD might have mainly attracted consumers who had a greater interest in their medicines and therefore potentially greater adherence; or who were motivated by the offer of a free blood pressure monitor.
“I sent out 40 letters to people and I got back seven responses and finished with five. And I found that the people actually involved in it were already pretty compliant. They were the ones that took their blood pressure tablets very seriously and were just looking for that extra edge, so compliance wasn’t really an issue.” P6
The recruitment process was also thought to be hindered by GPs’ low response to documenting confirmation of BP diagnosis and target BP.
“I probably had about 18 or 20 responses from the 36 that I sent out, but the recruits I got were all from one or two GPs. I had trouble [getting GPs’ confirmation of BP] and I think [I sent] numerous requests to their doctors and just had no response.” P10
Most patients did not believe they had problems with their blood pressure control or medicines. This is consistent with the pharmacists’ views that a proportion of patients had good adherence. Some participated to help research activities, but were pleasantly surprised that they learned a lot about their BP and its management over the course of the six-month intervention. Some patients participated because they knew they had a BP control problem or simply wanted to learn more about their BP.
Implementation of service
Pharmacists believed that the MedeMineCVD software was a useful organisational tool during the trial, assisting them to follow the trial protocol and helping with the printing of data collection forms.
“Much easier. [using MedeMineCVD] And with the letter the way it was worded and everything else going out to them, yeah, it was great. It was lovely we didn’t have to chase people up at all.” P1
“I think that generally the whole program on the computer makes it easier to see where you’re up to and what you’ve done and who you’ve got to go and things like that. That made it quite clear.” P3
While most pharmacists did not need to make changes to their day-to-day operation of the pharmacy, many were mindful of the time consumption for each appointment and the strain it posed on other pharmacy staff. Some pharmacists had to organise patient appointments after hours or when they had assistance.
“You couldn’t do it without two pharmacists, it was just impossible, so I had to do it in the afternoon when I had a second pharmacist. Often it would put the second pharmacist under a little bit of stress because I would be away from them.” P5
Pharmacist perspectives of the HAPPY Trial
Most pharmacists enjoyed their experiences in the HAPPY Trial, especially spending one-on-one time with patients and having a greater educational influence on patients’ health. All had built good relationships with their customers and felt that this rapport would extend beyond the completion of the trial.
“Probably very satisfying, I would say, in building relationships with people and being able to spend more time on a one-to-one basis going through again, not just the whole blood pressure side of things and managing that, but the whole lifestyle changes and things [you] can do with that to help reduce risk, strokes and things like that.” P1
Pharmacists mentioned that the questionnaires were time consuming for both pharmacists and patients and caused frustration at times; however, one pharmacist mentioned that it was the time spent with patients completing the questionnaire that helped to build the relationship and to know the patient better.
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Patient perspectives of the HAPPY Trial
Most patients were very pleased with the service that they were provided over the six months, and also with the personal results they achieved. Most patients reported that the HAPPY Trial facilitated better understanding and control of their blood pressure.
“A pleasant one, a good experience and probably an overall improvement of my blood pressure awareness.” C8
“Personally it came in a bit handy for me, because at the time I was having rather a big problem with my blood pressure. … Because being just a normal everyday person, and having a blood pressure problem for so many years, it was good for me to get a bit more information and learn a bit more about it rather than just think ‘I take these pills and what the heck are they for?’. Yes, it educated me in that way.” C6
Increased awareness of the potential role a pharmacist can play in consumers’ health management was commonly mentioned. Most were impressed with the pharmacists’ depth of knowledge and understanding of BP issues. Most patients also stated that they had a much better relationship with their pharmacist after participating in the trial and now see pharmacists as an additional source of health information.
“I’ve been very impressed with the - and I use this word carefully - the knowledge of the pharmacist and his knowledge of what does what and how it does it and why it does it etc. I was just in the habit of going along and saying I’ll be back in 10 minutes and that was it. … No doubt pharmacists have always had this vast knowledge but I’ve only just in recent times learned to tap it.” C11
“I think, with some people, we developed a new respect for the pharmacist in terms of understanding that we’re not just a supply tool and that we do have knowledge and that we can be part of their team in helping them attain their goals. A particular patient of mine, I made a suggestion to her GP to reduce her blood pressure and the GP unfortunately didn’t take any notice of it, but sometime later she went to her specialist in Melbourne and he changed her medication to my recommendation and I just feel that she has a new respect for me as being one of the professionals in her health care. So, with her in particular, I definitely feel that I have a different relationship with her and her husband. They really listened to everything that I said and I could see that they wanted to take control of their own health and they wanted to improve their health, and I think this was a way of doing that.” P10
However, a few consumers said that they had learned very little, and believed that the sole purpose of the trial was to record BP readings rather than being an educational intervention.
GPs perspectives of the service
One GP, who was aware of the HAPPY Trial, had found it very beneficial towards the diagnosis of a previously unknown illness for their patient. Another GP, while claiming to have no knowledge of the HAPPY Trial, recognised in the course of the interview that a scrappy note from the pharmacist in the patient’s history had resulted in changes to his patient’s medication. One other GP had no awareness of the trial, although he found the original GP faxback letter in the patient’s history.
All were in favour of pharmacists providing this service.
“I think when you’ve got a disease with no symptoms, it’s probably very helpful for a patient to have more than one person putting information that helps them realise why they have to take their tablet. So I think it’s helpful in that way, particularly people starting off with blood pressure control.” GP1
However, greater GP involvement was mentioned, especially more formalised reporting of the results to GPs.
“I think it would be nice to perhaps involve the doctors as one of the blood pressure takings that, a format in which the blood pressure is taken by the doctor [is] as well as part of that progress, perhaps the patient brings a form in with them for the doctor to have the information as well as the chemist and they take it with them to the chemist and the doctor.” GP2
No interviewed pharmacists had any direct contact with a GP and neither did the interviewed GPs have contact with a pharmacist during the 6-month trial.
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Most beneficial aspect of the HAPPY Trial to patients
Undoubtedly, all stakeholder groups believed that the most beneficial aspect of the HAPPY Trial to patients was the consumer’s ability to regularly monitor their BP with a home monitor. In conjunction with the education provided by the pharmacists and a discussion of downloaded readings, this process resulted in increased patient understanding of their BP, increased knowledge of what their target should be and when to seek advice if BP is high. Consumers expressed feelings of being ‘in control’ of their BP. For others, it provided them with the motivation to change their lifestyle.
“The most useful part I think was actually downloading their results so that they could see, in a picture form, how their blood pressure had been over the last three months and if they reached one goal and they achieved that goal and changed something in their life, they could actually see on their chart how their blood pressure had dropped”. P3
“A lot of patients lack an understanding of something as common as high blood pressure. A couple of patients I’ve had, they say they’ve got excellent blood pressure but when we look at the graph there’s a significant portion of those patients whose blood pressure is actually outside of their target levels. So I think this type of arrangement provides us with [an opportunity] to play an educational role which is lacking, I think, especially in the older people.” P7
“She was extremely happy with it [the 6-month service], she was happy with the outcome and she was very happy to have the monitor, she really appreciated that and I think she found the interaction with the pharmacist helpful as well.” GP1
“Mine [most useful aspect] was two things: I was able to monitor my heart [blood] pressure more than I would normally. And the second one, I got some information about how medications can affect you, like side effects. …. And I did have some of those side effects which I hadn't put down to medication. So now I'm working on righting that as actual things.” C4
“The knowledge I gained was what I also did on top of taking my medication. So there was obviously a dramatic improvement or a more steady reading when I was doing other activities that impacted on it, for example, exercise. So the discussion was obviously made around that. ... I think for me it was quite obvious that with regular exercise, albeit half an hour, the dramatic improvement or consistency in my blood pressure readings was obvious.” C8
Anecdotal information from all three stakeholder groups suggests that patients’ involvement and empowerment in the HAPPY Trial resulted in a number of positive health outcomes. Many patients initiated discussions with their GP resulting in changes to antihypertensive medication and interventions after noting extremely elevated BP at home and, in one patient, a diagnosis of renal artery stenosis.
“I don’t think any of our people really understood their blood pressure at all. They were shocked, and we had two quite serious interventions that trotted back to the GP and changed their medication completely because of the trial.” P9
“I probably had three or four who changed their medications and one of them had to have a halter monitor on because they were really concerned, and in the end, I think they might have had some sort of problem, a heart problem since, actually.” P5
“Just two weeks into the trial, it was quite clear that the medication was inadequate. And my blood pressure was nowhere near target, which the doctor never picks up, because you go and see the doctor once every six months. So I then had to go straight and have my prescription increased which then fixed it totally. So very, very important [the service].” C10
“I think of one of the results. We did increase her [the patient’s] blood pressure medication over that period of time, which I think is a useful thing.” GP2
“One of our patients, because he monitored his blood pressure during the trial, actually picked up that one time he had a really high reading and he ended up in the hospital and they found that he actually had a heart attack. So in a way for this particular patient, it was life saving for him.” P4
“Well it’s actually been extremely helpful for this patient because it’s turned out that she had very bad blood pressure control at home, and I’ve been trying to get her blood pressure under control for years and have intermittently brought it under control in the rooms, but it was actually very poor control at home and she turned out to have a renal artery stenosis. She’d gone off and had an investigation, so it’s actually been extremely helpful really.” GP1
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For one patient, it was obvious that recording his BP without pharmacist education did not help him manage or have better understanding of his BP.
“I think they [patients] would become interested if they could get a reading that showed them where they were actually going with it, what they were up to or whether they could tell whether they were fine. But there was nothing [on the monitor] to say it was 80 [mmHg] and 120 [mmHg] is normal blood pressure. When it gets to say 160, 170, is that safe? Or it drops down to 80 or 70 or something like that, is it critical?” C7
“If people tried it, found they had very high peaks and high lows and there was something in their lifestyle or through their doctor [to] control it better, I think this would be terrific to have one of those. But just to go higgledy piggledy and just read it and take it in every three months and you don’t get any feedback from it, it would be pretty much mundane after a while.” C7
Least beneficial aspect of the HAPPY Trial to patients
Most pharmacists and consumers could not fault the HAPPY Trial and were unable to make many recommendations to improve the service.
“I don't know that you could improve it because it was very good.” C3
The only negative criticisms were concerns about measuring BP on a day-to-day basis becoming a burden for patients in the final months of the trial and perceived lack of benefit, by some pharmacists and patients, from the prescription reminder service.
Provision of service
All pharmacists and most consumers thought that the provision of this service should come from the pharmacist. It was generally recognised that GPs are too busy to provide such an extensive service as that offered through the HAPPY Trial. It was believed that pharmacists had the knowledge to implement the program. Consumers also thought that the pharmacy provided a more relaxed environment than the doctor’s surgery and that they felt comfortable discussing issues with the pharmacists. Pharmacists’ general availability for quick follow-up questions was also pointed out as being advantageous.
“I suppose it's just a support mechanism for the GPs as well, isn't it? To support what they're probably already doing and saying as well. It's probably just a little bit more convenient to be honest, to be able to access the pharmacist as well. I found it more convenient… .” C8
“I tend to find the pharmacy a little bit more relaxing. So the service being provided through the pharmacy was fantastic. I think most of us get a little bit uptight going to doctors There’s usually something wrong when we’re going to see a doctor and so it makes us a little bit more uptight.” C1
“I know my GP is pretty busy. So yes, if the pharmacy could do it, yes it would make like a lot easier, and I think more people don’t realise that a pharmacist can do what a doctor can do.” C5
“Yes, it was much easier to talk to her. You always feel like you have a time thing when you go to the doctor, and half the time I forget to ask things.” C6
Only two consumers would have preferred this service to be delivered by the GP or nurses within the GP clinic.
The future of the HAPPY Trial
Recruitment
It was believed by pharmacists, GPs and patients that GPs need to play a role in recruiting patients for the service. Pharmacists and GPs further suggested, as an extension to the current recruitment strategies, that newly diagnosed or poorly controlled consumers could be referred by their doctors. One suggestion made was an inbuilt referral prompt in the GP software.
“I think we do need to get GPs onboard with us to identify the patients who would most benefit from the service.” P10
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“We would probably target our doctors a lot more for the identification of newly diagnosed hypertensives or people who had hypertension and use the program, from that point of view, to try and establish a good culture from the outset.” P2
“I guess some sort of pro-forma fax particularly built into our medical software would be handy, where we could initiate when we first write the script a referral that says ‘Please enrol this patient in the community pharmacy new blood pressure patient check’ and tick the box and ‘Please report back to me in one month’ - three months something like that.” GP1
Pharmacists also suggested that, rather than a mass mail out of EOI letters, MedeMineCVD could prompt pharmacists to speak to patients identified as being apparently nonadherent, so that pharmacists could then assess whether the patient might benefit from the service.
“There would be a set up whereby you would enrol them in the trial in your pharmacy there. You certainly could do that [use MedeMineCVD] but then it would just flag you when you entered their [patient’s] profile that this person qualifies for a HAPPY program, so you know that from there.” P2
Length of service
There was no consensus amongst the participants as to the most suitable number of appointments or duration of the service. Every combination including monthly visits to 12 month follow-ups was suggested. There was agreement that the appointments should be spaced no more than three months apart.
BP monitors
BP monitors were considered to be an integral component of the HAPPY Trial by all stakeholder groups. However, most also said that they should not be provided free of charge to the consumers. Some consumers mentioned that they had not used the monitor frequently since the trial ended and therefore considered it a wasted resource in the longer term.
Some suggestions for supplying BP monitors included: only supplying the monitor for the duration of the trial; going to the pharmacy for measurements, with patients having the option to purchase a monitor on completion; private health insurance subsidy; bulk purchasing of monitors by a supporting body and pharmacies selling them at a cheaper price; or a subsidy, especially for low income earners.
“Yes I think it should be [given back to pharmacy after completion of service], then they could pass it on to somebody different. Look if somebody’s that interested they’d go and buy one.” C5
“You would encourage people to start having their blood pressure taken at the pharmacy or encourage them to purchase a machine. Let’s forget about the freebie.” C11
“Given private health insurance, if that could be brought to bear on a program like this, I'm sure that the private health insurance people would fund that, but not everyone has got that.” P2
“I think it’s a matter of paying for it. If there’s a deal to be secured through, that if these monitors that meet a certain standard and could be downloaded in decent supply to pharmacies that join up to this HAPPY program, at the right rate because they're going to sell 50,000 of them. … It would have to be led from the top, I would say … because it can't be on an individual pharmacy basis because the deal is never going to come off … and offer them to the customers at an excellent price.” P2
“Maybe they have it at 50% of the cost or something so then they still have an incentive to do it because they get money back, but they had to put something into it in the first place.” P1
“So I think if the patient was to see the benefit of being part of a service like this, they may even be willing to invest in a blood pressure machine for the purpose. ... The only portion of patients which may be disadvantaged are those with limited income, but those are the patients that may receive extra help from the funding point of view to invest in a machine.” P7
Limitations
While many EOI letters were returned by consumers, most failed to provide their GP’s details. Therefore, the GP contact list was small and only three GPs were willing to participate in telephone interviews. Greater GP participation may have resulted in more in-depth understanding of their views and experiences. Observation bias may also be a limitation of this study, as the researcher who conducted the focus groups and telephone interviews was also part of the research team who carried out the HAPPY Trial.
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Discussion
The pharmacists and consumers who participated in the focus groups or telephone interviews were drawn from across the PhAria distribution. Further, a spread of pharmacies in the HAPPY Trial service was targeted to ensure consumer experiences were from a broader base.
Overall, the HAPPY Trial was positively received by all stakeholder groups. Distance education was a well-accepted tool for training pharmacists. Motivational interviewing was an area which pharmacists believed needed to be covered more extensively. This is backed up by the training assessment where one of the motivational interviewing questions was only answered correctly by 50% of participants. Therefore, future training courses will need to encompass even more time and practical exercises in motivational interviewing.
MedeMineCVD can be a useful tool to identify nonadherent or nonpersistent consumers. However, using dispensing data from one pharmacy only, may lead to inaccurate identification of nonadherence or nonpersistence. Difficulty arises from privacy laws, which preclude sharing of dispensing data among pharmacies. An additional way to assess nonadherence or suitability of patients may need to be used in conjunction with MedeMineCVD to select consumers most at need of this service. This may involve greater input from pharmacists at the selection stage or GPs referring patients to the pharmacy.
The HAPPY Trial was positively received by all stakeholder groups. Pharmacist and consumer satisfaction with the service was high. In fact, most could not think of ways, in which the service could be improved, so highly regarded was every component. The length of the data collection instruments was seen as the only negative impact on the service, as they lengthened the interview time and some questions were considered too personal. In future implementation of this service, many of the questions which have only been included for research purposes and do not impact upon the service, should be omitted from the forms to reduce the consultation time.
Ideally, it was thought that the HAPPY service should be provided by pharmacists. It was commonly recognised that GP resources were stretched and that an extension of their current service may not be possible. Pharmacies were seen as a relaxing environment and the pharmacists as approachable. For the same reason, expecting substantial collaboration between pharmacists and GPs in delivering such an intervention is probably not feasible.
While GPs believed that a pharmacist-led educational program would be beneficial to the patient, the issue of information sharing between the two professionals was once again raised, as was the case in the pre-trial focus groups. While all GPs had received some information either at the beginning of the trial from pharmacies or feedback through the patient, a more formalised and personalised communication is required. In future rollout of the HAPPY service, pharmacists should be supplied with formal referral slips to share relevant information with GPs.
It was evident from the qualitative information that, while pharmacists and consumers believed patients were mostly adherent, the HAPPY Trial has been instrumental in helping patients manage their BP and gain a better understanding of their BP. It has resulted in changes, either to medications or lifestyle, to enable better control. The two most important components of the intervention were identified as being consumers monitoring their own BP regularly and the education received from the pharmacists using the downloaded measures from the BP monitors as a means to engage the consumers. . Most consumers felt they had been given the tools, to have a greater input into their BP management.
Unfortunately, not all consumers had the same beneficial interactions with their pharmacist or received the interventions as intended. This became obvious from some of the comments made. As is the case with any service provided, there will be variability among the providers of the service, and some may be better at it then others. However, for those patients, it shows that the supply of a BP monitor alone may not be sufficient to give them the same understanding and control of their BP as when the supply is coupled with pharmacist education. Therefore, the pharmacist’s interaction with the consumer is an important component of the intervention package. Accreditation of pharmacists to supply the service should address this issue of varying standards in any future rollout of the service.
The future supply of free BP monitors was questioned, and whilst they are an important component to this service, most agreed that they should not be supplied free of charge, as the value of service may be diminished by consumers who are participating solely in order to receive a free monitor.
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Overall Summary
The research objective was to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications. A number of specific research questions were posed.
Can the proposed intervention package service, compared to usual care, improve patient adherence and/or persistence with antihypertensive medications?
The proportion of participants who were judged to be adherent by the Morisky score increased in both groups from baseline to six months, but there was no significant difference in adherence rates between the groups. It was observed in both groups that, while some individuals achieved improved adherence, others became nonadherent, meaning that a connection between the intervention and improved adherence cannot be made.
Similarly, while significant improvements in adherence occurred in the PCG on a number of measures of adherence, no significant differences between the groups were demonstrated. It cannot, therefore, be concluded that the intervention resulted in improved adherence in comparison to usual care.
Subgroup analysis of participants who were identified as nonadherent (by Morisky score) at baseline showed a significant improvement for the PCG over the UCG in the TABS adherence score. In the subgroup of nonadherent consumers (by Morisky score) who also had above target BP, the difference in the TABS adherence scores between PCG and UCG fell just short of significance. While the PCG in both subgroups demonstrated significant improvements in the Morisky score and MedsIndex score from baseline to six months, differences between the groups were only significant for the subgroup of participants who were nonadherent and above target BP.
Subgroup analysis of participants who were above their target blood pressure at baseline showed significant improvements in Morisky score and the MedsIndex score for the PCG group at six months, but the differences compared to the UCG were not significant at the 5% level.
Can the proposed intervention package service, compared to usual care, improve patients’ blood pressure control?
While significant decreases in both diastolic and systolic BP were observed in both groups, the intervention was associated with a significantly greater reduction in mean systolic blood pressure in comparison to usual care. The change in the PCG was -10 mm Hg.
Subgroup analysis of the participants who were nonadherent at baseline showed a decrease in systolic blood pressure in the PCG group of the order of 13 mm Hg, which was significantly greater than the drop in the UCG. The literature indicates that this degree of change in systolic blood pressure could be associated with reduced cardiovascular risk if it were able to be sustained.
Subgroup analysis of participants who were above target blood pressure at baseline showed a decrease in systolic blood pressure in the PCG group of the order of 16 mm Hg and 20mmHg in those who were also nonadherent according to Morisky score at baseline. These reductions were significantly greater than the drop in the UCG and suggest that patients with blood pressure above target may achieve even greater long-term health benefits from the intervention.
Even though improvement in adherence was not demonstrated, the intervention has shown potential to reduce cardiovascular risk. Whether or not the self-reported adherence measures were sensitive enough to measure a change in adherence, the intervention has resulted in behaviour change that has improved blood pressure control.
Can the proposed intervention package service, compared to usual care, change patients’ health beliefs and attitudes?
There were no significant changes in the health beliefs and attitudes of participants between groups at baseline or six months, as measured by the subsections of the BBQ, although there was a tendency towards greater increase in ‘confidence’ following the intervention than after usual care.
This is supported by comments from focus group discussions and interviews with consumers following the trial, most of whom were very pleased with the service and also with the personal results they achieved. They reported that the service had facilitated better understanding and helped them achieve better control of their blood pressure.
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Can the proposed intervention package service, compared to usual care, improve patients’ quality of life?
The changes in utility scores for patient quality of life, as measured by AQoL8, were not significantly different within or between groups over the period of the trial. The AQoL8 is a measure of general quality of life. While it is preferable to use disease-state specific QoL measures, it is not surprising that none exists for hypertension, as it is a largely symptomless condition with minimal expected impact on QoL.
Can the proposed intervention package service, compared to usual care, generate more benefit at a cost (i.e., the Incremental Cost-Effectiveness Ratio, ICER) that is reasonable and acceptable to the Australian society?
According to the results shown by the ICER, the intervention is highly cost-effective, because the cost per Quality-Adjsuted Life-Year (QALY) gain of AU$6,322.58 is far less than the benchmark AU$70,000 accepted by the Australian government.
Are consumers and other stakeholders (Pharmacists and GPs) satisfied with the service?
Since consumer satisfaction with the pharmacies was already high at baseline, there was little room to demonstrate improvement quantitatively. This is often the case in research of this nature, as consumers may be satisfied with what they are receiving without realising what they could potentially receive.
The qualitative focus groups and interviews revealed that the HAPPY Trial was positively received by all stakeholder groups. Pharmacist and consumer satisfaction with the service was high. Every component was so highly regarded that most could not think of any ways to improve the service. Some criticism was made of the time taken for data collection, but this could be reduced when implementing a program, as some data were collected for research purposes only. Consumers thought it appropriate and convenient that the service be offered through community pharmacies.
The HAPPY Trial was seen to have been instrumental in helping patients to gain better understanding of their BP and to manage it better through medication and/or lifestyle changes. Most consumers felt they had been given the tools to have a greater input into their BP management.
Can the service be readily implemented within the current community pharmacy structure?
The focus group discussions and interviews with consumers, pharmacists and GPs prior to the trial indicated that consumers viewed community pharmacies as a comfortable and convenient place for the service to occur. Pharmacists felt that, with appropriate training, they were capable of delivering the service. GPs emphasised the need for a teamwork approach to ensure patients were referred back to them for more complex issues.
Lack of adequate space within some pharmacies to conduct private consultations was mentioned by stakeholders as a barrier to offering any pharmacy service focusing on chronic disease management because of risks to patient confidentiality. Pharmacies accredited under the Quality Care Pharmacy Program (QCPP) – a high proportion of community pharmacies – are required to have such an area; however, in some cases this may not have been considered adequate by consumers. An initial investment may need to be made to set the pharmacy up appropriately. This was addressed in the trial by giving pharmacies a small allowance for the purpose.
The main facilitator for successful implementation of a community pharmacy adherence program was seen to be remuneration for pharmacists at a level at least equivalent to what could be earned by the pharmacy for dispensing prescriptions in the same time period. In the trial, pharmacists were remunerated per patient according to the expected time involved.
Pharmacists believed that the MedeMineCVD software was a useful organisational tool during the trial, assisting them to follow the trial protocol and helping with the printing of recruitment letters and data collection forms. If the service were to be implemented, MedeMineCVD will be a useful tool to identify potential participants and preferably should be embedded into dispensing software programs to allow seamless integration of the intervention package into the community pharmacy workflow. MedeMineCVD would also need to be adapted to suit the delivery of the service rather than the requirements of the research, which is its current purpose, i.e. not all the forms that are currently generated would be required.
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Some difficulties with recruitment were described, however, in that a higher proportion of patients were reported being adherent at baseline than expected. Considering the highly effective reduction in systolic BP in subgroup analyses,screening for eligibility using Morisky score and/or control of blood pressure relative to target, after identification by MedeMineCVD (or an adaptation) may be useful strategies with which to better target potential recipients of the service.
The time taken for appointments was seen as a barrier, particularly in relation to the length and nature of some of the questionnaires. While most pharmacists did not need to make changes to day-to-day operation of the pharmacy in order to participate in the trial, they aware that the time involved posed a strain on other pharmacy staff. Some pharmacists had to organise patient appointments only when extra assistance was available, or after hours. The duration of appointments should readily be able to be reduced for service implementation by omitting questions required for research purposes only e.g. some of the demographic information, quality of life and business case questions should be removed. For implementation of the service, pharmacists should also record a patient’s BP, adherence issues, risk factors and pharmacist plan of management.
What is the consumer’s willingness to pay for the service?
Consumers indicated that, on average, they would be willing to pay $20 per month (one or two visits) for the service.
Is there an economically viable business case for the service?
The service did not demonstrate any tangible financial benefit to the pharmacy. Pharmacists, however, commented on the value such services have in building customer loyalty.
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Strengths
In designing the HAPPY trial, several innovative strategies were included:
• use of MedeMineCVD to identify potential participants; • use of MedeMineCVD to simplify the administrative load of the pharmacists; • provision of pharmacist education in face-to-face, print and online modes; • provision of home BP monitor to usual care patients at the conclusion of the trial; and • an offer for usual care patients to receive the intervention service from the pharmacist at the conclusion of
the trial.
The intent of these strategies was to optimise recruitment and retention of both pharmacists and patients in the trial. Sixty pharmacies were recruited, but five withdrew prior to commencement. Another pharmacy withdrew after baseline data collection due to change of ownership. Retention rate was 98.2% (54/55). Retention of patients was 86.0% in the PCG and 93.6% in the UCG at six months.
In addition, a hidden control group was identified in the UCG pharmacies to allow comparison of measures of adherence (MedsIndex and MPR) available from dispensing histories within the pharmacy where the patient was recruited. This feature of the methodology is not usually feasible and represents an innovate approach. While insignificant differences between the groups do not guarantee that a Hawthorne effect has not occurred, it provides at least some measure of comparison between usual care and a true control.
Limitations
Although MedeMineCVD identified patients apparently experiencing problems with adherence or persistence to their medications, high proportions reported adherence at baseline. This may be due, in part, to the incomplete data available from one pharmacy. Given the large number of potential participants who were sent invitations to participate and the small numbers responding, the sample may be biased towards those who were already interested in managing their medicines to best advantage.
The calculated sample size of 182 participants in each group was not quite achieved. Assumptions made in the sample size calculation were not observed in the study i.e. the adherence at baseline was greater than 50%, adherence in the intervention group did not increase by 15% and adherence also increased in the usual care group. Experience from this trial will inform calculation of sample size for future studies.
As with all studies of adherence, there is no gold standard for measurement. Self-reported measures are subject to the Hawthorne affect and to recall bias. Calculations from refill data are limited by incomplete information, given that records are not linked between pharmacies, and by the assumption that if the patient has collected the medicine thy have actually taken it as prescribed.
Conclusions As no significant differences between the groups were demonstrated for any of the adherence measures, it cannot be concluded that the intervention was responsible for improved adherence in the PCG in comparison with the UCG. However, the intervention must have resulted in a change of behaviour in consumers, as a change in mean systolic blood pressure that was significantly greater in PCG than UCG patients was achieved. The magnitude of the mean change appears capable, if sustained, of reducing longer-term cardiovascular risk. In a clinical sense, this is a more important outcome than improving adherence alone. The intervention was evaluated as highly cost-effective.
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Future Implications
For potential future implementation of the HAPPY service, the main focus may need to shift from improving medication adherence to reduction of BP. In order to optimise the effect of the intervention, it would be useful to test the effect of a two-stage identification and screening process for assessing eligibility to participate in the program. A software application such as MedeMineCVD, adapted to suit the service rather than the research, could be used to flag patients who are likely to benefit from an intervention. Further screening could be performed using Morisky scale and BP measurement. If nonadherence is evident and/or BP is above target, the patient would be eligible to enrol in the program. However, this may need to be tested in large RCTs before wider implementation through community pharmacies.
Further, for successful implementation of the service: – Pharmacists require appropriate and accredited training to deliver the service; – Pharmacies will be expected to have the space to conduct private consultations; – Pharmacists require appropriate remuneration to provide the service; – MedeMineCVD is a useful tool to identify potential participants and to assist pharmacists with
administrative tasks; however it would need to be amended to be suitable for service provision as opposed to research purposes and preferably should be integrated into the dispensing software.
– Data collection will need to be reduced to focus on service aspects and not research.
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121. Sesso HD, Chen RS, L’Italien GJ, Lapuerta P, Lee WC, Glynn RJ. 2003. Blood pressure lowering and life expectancy based on a Markov model of cardiovascular events. Hypertension 42:885-890. DOi 10.1161/01. HYP.0000097602.67134.4D 122. Johannesson M, Hedbrant J, Jonsson B. 1991. A computer simulation model for cost-effectiveness analysis of cardiovascular disease prevention, Med.Inform.16(4):355-362 123. Salkeld G, Phongsavan P, Oldenburg B, Johannesson M, Convery P, Graham-Clarke P, et al. 1997. The cost- effectiveness of a cardiovascular risk reduction program in general practice. Health Policy 41:105-119 124. The Pharmacy Guild of Australia, April 2008, The Pharmacy Guild of Australia Business Case for Participation in the PMP program – Phase 1, version 1.00. Accessed September 2009 from http://www.guild.org.au/uploadedfiles/Professional_Pharmacy_Services/PPS_Programs/Medication Profiling/_ business_case_030408.pdf 125. The Pharmacy Guild of Australia, April 2008, The Pharmacy Guild of Australia Business Case for Participation in the DAA program – Phase 1, version 2.00. Accessed September 2009 from http://www.guild.org.au/uploadedfiles/Professional_Pharmacy_Services/PPS_Programs/Dose Administration _ Aids/6_business_case.pdf 126. Olsen JA, Smith RD. 2001. Theory versus practice: a review of ‘willingness-to-pay’ in health and health care. Health Econ 10:39-52 127. Blumenschein K, Johannesson M, Yokoyama KK, Freeman PR. 2001. Hypothetical versus real willingness to pay in the health care sector: results from a field experiment. J Health Econ 20:441-457 128. Ryan M, Watson V. 2008. Comparing welfare estimates from payment card contingent valuation and discrete choice experiments. Health Econ. Doi: 10.1002/hec.1364 129. Peterson G, Fitzmaurice K, Kruup H, Jackson S, Ball M, Rasiah R. 2005. Pharmacy-based program to tackle coronary heart disease in the Australian community. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=252 130. Chen T, Brien J, Ng K, Whitehead P, Ellitt G, Anderson E. 2005. From hospital to community: a multidisciplinary ‘continuity of care’ model for cardiovascular patients, involving community pharmacists. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=256 131. Gilbert A, Beilby J. 2000. Quality use of medicines in the community implementation trial. Accessed September 2009 from http://www.guild.org.au/uploadedfiles/Medication_Management_Reviews/Overview/Andy Gilbert 2000_ HMR_project_report.doc 132. Anticevich S, Armour C, Krass I, Saini B. 2003. Pharmacy Asthma Action Plan Project. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=243 133. Krass I, Taylor SJ, McInman AD, Armour CL. 2005. Community pharmacists’ role in the continuity of care in type 2 diabetes: an evaluation of a model. Accessed September 2009 from http://www.guild.org.au/uploadedfiles/Research_and_Development_Grants_Program/Projects/2001-075_fr.pdf 134. Roberts M. 2004. Effectiveness and cost effectiveness of dose administration aids (DAAs). Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=261 135. Dunphy D, Palmer I, Benrimoj C, Robers A. 2005. Change management and community pharmacy project. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=273 136. Rieck A, Clifford R, Everett A. 2005. Community pharmacy weight management project stages one and two. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=283 137. Krass I, Armour C, Taylor S, Mitchell B, Stewart K, Peterson G, Hughes J. 2005. Pharmacy diabetes care
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program. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=260 138. Urbis Keys Young. 2005. Evaluation of the home medicines review program – pharmacy component. Accessed September 2009 from http://www.guild.org.au/mmr/content.asp?id=406 139. Nissen L, Tett S. 2005. Rural community pharmacists integrating care for people with complex health needs. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=249 140. Roberts M. 2006. Effectiveness and cost effectiveness of dose administration aids (DAAs) phase 3, final report. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=280 141. Calder R, Wheeler L, Bentley K, Moore K, Minford M. 2006. Pharmacy continence care program stage 2. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=275 142. Nova Public Policy. 2006. Evaluation of the third community pharmacy agreement research and development grants program. Accessed September 2009 from http://www.guild.org.au/research/project_display.asp?id=286 143. The Association of Professional Engineers, Scientists & Managers, Australia. The community and hospital pharmacists’ remuneration survey report, 2009 Edition. Accessed February 2010 from http://www.apesma.asn.au/surveys/pharmacists/index.asp 144. Attendances by general practitioners, level B. Accessed February 2010 from http://www9.health.gov.au//mbs/fullDisplay.cfm?type=note&q=A5&qt=noteID&criteria=a5 145. National Hospital Cost Data Collection round 12. Accessed February 2010 from http://www.health.gov.au/internet/main/publishing.nsf/Content/Round_12-cost-reports 146. Van Gool K, Haas M, Sainsbury P, Gilbert R, 2007. When is an ounce of prevention worth a pound of cure: the case of cardiovascular disease? Centre for Health Economics Research and Evaluation, University of Technology Sydney, working pager 2007/1. Accessed February 2010 from http://www.chere.uts.edu.au/pdf/wp2007_1.pdf 147. Folland S, Goodman AC, Stano M. 2007. The economics of health and health care. Fifth edition. USA: Prentice Hall
A systematic review of published studies describing cardiovascular disease programs, with a focus on those studies that are relevant to the following, has been undertaken:
• community pharmacy • management of hypertension • adherence / persistence
All studies identified as relevant have been entered into an Access database and these have then been reviewed independently by two researchers, with the evidence graded according to standard NHMRC criteria.
Meta-analysis of the studies was not considered appropriate due to the diversity of methods and outcomes used.
Following the review and grading of evidence, any discrepancies were resolved through consensus and where necessary with the involvement of a third researcher. The final product is an electronic, searchable database of relevant articles, including an assessment of the quality of studies.
The literature search was partly developed from previous work done by the UMORE team as part of the Pharmacy Cardiovascular Health Care Model 2005. The broad terms of this previous work meant that any literature published prior to 2005 and relevant to the current study would already be available to the research team.
Consequently, the new searches were carried out with the publication date range limited to 2005 to 2008. In addition, a robust review of the reference lists of all papers identified through the database searches, was conducted to provide further re-assurance that all relevant material was identified.
It had been planned to include the Community Pharmacy Research Database in this literature review, however this database has consistently been out of service during the time this review has been undertaken.
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Medline
via PubMed
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
15425
2 hypertension or blood pressure or cardiovascular or cardiac
137089
3 persistence or adherence or concordance or adherence
38949
4 1 and 2 and 3 100
International Pharmaceutical Abstracts (IPA)
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
4518
2 hypertension or blood pressure or cardiovascular or cardiac
5010
3 persistence or adherence or concordance or adherence
2254
4 1 and 2 and 3 85
Cochrane library
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
425
2 hypertension or blood pressure or cardiovascular or cardiac
8743
3 persistence or adherence or concordance or adherence
3905
4 1 and 2 and 3 20
EMBASE
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
13577
2 hypertension or blood pressure or cardiovascular or cardiac
240735
3 persistence or adherence or concordance or adherence
33346
4 1 and 2 and 3 71
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INFORMIT
Using all Health databases contained in Informit
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
2111
2 hypertension or blood pressure or cardiovascular or cardiac
1008
3 persistence or adherence or concordance or adherence
315
4 1 and 2 and 3 3
CINAHL
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
1200
2 hypertension or blood pressure or cardiovascular or cardiac
19835
3 persistence or adherence or concordance or adherence
7031
4 1 and 2 and 3 31
Kinetica
Incorporated in National Library of Australia
Search Terms Results
1 pharmacy or pharmacies or pharmacist or pharmaceutical services
2850
2 hypertension or blood pressure or cardiovascular or cardiac
2991
3 persistence or adherence or concordance or adherence
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin McNamara and Jennifer McDowell from the same department.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because we are interested in the opinions and experiences of consumers with high blood pressure in community-based disease management. You have either been contacted because you have supplied us with your contact details via an expression of interest form, which you most likely obtained through your community pharmacy.
The aim/purpose of the research
The aim of this preliminary study is to identify and explore the barriers and facilitators to implementation of a blood pressure medication compliance service. We are conducting interviews and focus groups to understand the perspectives of stakeholders – consumers, general practitioners and community pharmacists – on the development and implementation of such a service through community pharmacies. This study is being carried out as part of a Research Tender from The Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement Research and Development Program.
Possible benefits
The link between blood pressure control and health outcomes is clearly established. The role of pharmacists in monitoring and assisting consumers with medication compliance to achieve desired therapeutic outcomes is also well established. It is anticipated that the proposed blood pressure medication compliance service will assist consumers with hypertension to achieve target blood pressure; however, there will be no direct benefit for you from participation in this preliminary stage of the project.
What does the research involve?
The study involves being interviewed individually or participating in a focus group meeting with 6-8 other stakeholders. Interviews will be conducted at a mutually convenient time and place. The focus group will be organised at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville (or by teleconference) at a time convenient for all the participants. The focus group will be moderated by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. The focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants, and later transcribed verbatim. The transcript will be analysed for major themes and concepts.
How much time will the research take?
Interviews and focus group meetings will each take approximately one hour.
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Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
Payment
To compensate for your time, we will be offering you an honorarium of $100.00.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time up until you have approved the transcript of your interview or focus group.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for 5 years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research <project number:2008001571> is being conducted, please contact:
Assoc Prof Kay Stewart
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin McNamara and Jennifer McDowell from the same department.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because we are interested in the opinions and experiences of community pharmacists in community-based disease management. You have either been contacted through your community pharmacy or have supplied us with your contact details via an expression of interest in the project.
The aim/purpose of the research
The aim of this preliminary study is to identify and explore the barriers and facilitators to implementation of a blood pressure medication compliance service. We are conducting interviews and focus groups to understand the perspectives of stakeholders – consumers, general practitioners and community pharmacists – on the development and implementation of such a service through community pharmacies. This study is being carried out as part of a Research Tender from The Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement Research and Development Program.
Possible benefits
The link between blood pressure control and health outcomes is clearly established. The role of pharmacists in monitoring and assisting consumers with medication compliance to achieve desired therapeutic outcomes is also well established. It is anticipated that the proposed blood pressure medication compliance service will assist consumers with hypertension to achieve target blood pressure; however, there will be no direct benefit for you or your patients from participation in this preliminary stage of the project.
What does the research involve?
The study involves being interviewed individually or participating in a focus group meeting with 6-8 other community pharmacists. Interviews will be conducted at a mutually convenient time and place. The focus group will be organised at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville (or by teleconference) at a time convenient for all the participants. The focus group will be moderated by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. The focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants, and later transcribed verbatim. The transcript will be analysed for major themes and concepts.
How much time will the research take?
Interviews and focus group meetings will each take approximately one hour.
Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
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Payment
To compensate for your time, we will be offering you an honorarium of $100.00.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time up until you have approved the transcript of your interview or focus group.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for five years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research < project number: 2008001571> is being conducted, please contact:
Assoc Prof Kay Stewart
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin McNamara and Jennifer McDowell from the same department.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because we are interested in the opinions and experiences of general practitioners in community-based disease management. You have either been contacted through your general practice or have supplied us with your contact details via an expression of interest in the project.
The aim/purpose of the research
The aim of this preliminary study is to identify and explore the barriers and facilitators to implementation of a blood pressure medication compliance service. We are conducting interviews and focus groups to understand the perspectives of stakeholders – consumers, general practitioners and community pharmacists – on the development and implementation of such a service through community pharmacies. This study is being carried out as part of a Research Tender from The Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement Research and Development Program.
Possible benefits
The link between blood pressure control and health outcomes is clearly established. The role of pharmacists in monitoring and assisting consumers with medication compliance to achieve desired therapeutic outcomes is also well established. It is anticipated that the proposed blood pressure medication compliance service will assist consumers with hypertension to achieve target blood pressure; however, there will be no direct benefit for you or your patients from participation in this preliminary stage of the project.
What does the research involve?
The study involves being interviewed individually or participating in a focus group meeting with 6-8 other stakeholders. Interviews will be conducted at a mutually convenient time and place. The focus group will be organised at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville (or by teleconference) at a time convenient for all the participants. The focus group will be moderated by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. The focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants, and later transcribed verbatim. The transcript will be analysed for major themes and concepts.
How much time will the research take?
Interviews and focus group meetings will each take approximately one hour.
Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
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Payment
To compensate for your time, we will be offering you an honorarium of $100.00.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time up until you have approved the transcript of your interview or focus group.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for 5 years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research <project number:2008001571> is being conducted, please contact:
Assoc Prof Kay Stewart
Department of Pharmacy Practice
Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade
Cardiovascular disease (CVD) is a major cause of illness, disability and death in the Australian community.
High blood pressure (BP) is known to be an important risk factor for development of CVD.
High blood pressure can be controlled by attention to diet and exercise and by taking medicine.
One of the biggest hurdles is that most people do not take their medicines in the best way all the time. Who might be able to help them? e.g. with practical hints, education, motivation
Leads into community pharmacists having the drug knowledge
Other advantages of running a service through community pharmacies e.g. readily accessible, seen frequently, previous successful examples of disease state management models run by community pharmacists.
What could community pharmacists provide? e.g. (prompt if not forthcoming)
• Education on importance of controlling BP
• Working with the patient to understand reasons behind nonadherence and developing strategies to improve adherence
• Monitoring adherence
• Education and support for patients to monitor their blood pressure at home
What would make it easy for a service to be provided from this source? (Facilitators)
• Pharmacists remuneration, sufficient trained staff, collaboration with doctor and patient as a team
• Doctors remuneration
• Patients convenient location, low cost, privacy
What would make it difficult? (Barriers) e.g. (from previous experience)
• Pharmacists lack of time, money, expertise
• Doctors my job, not pharmacists, patient could get mixed messages
• Patients may not recognise the need, time, cost, lack of privacy
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio-taped Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio-taped Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, up until approval of the transcript, without being penalised or disadvantaged in any way.
I understand that I will be given a transcript of data concerning me for my approval before it is included in the write up of the research. I understand that any data that the researcher extracts from the focus group or interview audio-tapes or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-tapes or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio-taped Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio-taped Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, up until approval of the transcript, without being penalised or disadvantaged in any way.
I understand that I will be given a transcript of data concerning me for my approval before it is included in the write up of the research. I understand that any data that the researcher extracts from the focus group or interview audio-tapes or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-tapes or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
Signature ______________________________________
Date ___/___/_____
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Appendix 8: Phase 2 - General Practitioner Consent Form
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio-taped Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio-taped Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, up until approval of the transcript, without being penalised or disadvantaged in any way.
I understand that I will be given a transcript of data concerning me for my approval before it is included in the write up of the research. I understand that any data that the researcher extracts from the focus group or interview audio-tapes or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-tapes or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with:
• Dr Johnson George, and Jennifer McDowell from the same department • Kevin McNamara, from the same department and also the Greater Green Triangle University Department of
Rural Health (Flinders and Deakin Universities) • Dr Shane Jackson, Professor Gregory Peterson, Dr Luke Bereznicki, Peter Gee and Angus Thompson, Unit
for Medication Outcomes Research and Education (University of Tasmania) • Associate Professor Jeffery Hughes, School of Pharmacy, Curtin University, WA
• Dr Michael Bailey, Department of Epidemiology and Preventive Medicine, Monash University • Dr Arthur Hsueh, Centre for Health Policy, Programs and Economics, The University of Melbourne
Why did we choose this particular person/group as participants?
Cardiovascular Disease accounts for 39% of deaths of Australian adults. Despite this, patients with common risk factors often receive treatment that is suboptimal. High blood pressure (BP), for example, is an extremely common risk factor, affecting about one third of adults, and is the most common reason for visiting a GP in Australia. Despite the availability of effective treatments, only a quarter of all those diagnosed and half of those taking medication achieve target BP levels.
Lack of adherence to medicines and failure to persist with the taking of medicines are acknowledged as major reasons for uncontrolled blood pressure. Research conducted in Australia and overseas clearly supports an active role of the community pharmacist in management of chronic disease, in collaboration with other health care professionals. Such studies have highlighted opportunities for community pharmacists to provide a range of services to support patients in self-managing their conditions.
You have been approached to participate in this study because we are seeking community pharmacists who are interested in providing such a service to people with hypertension, to assist them to use their medications optimally with a view to improving their blood pressure control.
The aim/purpose of the research
The aim of this project is to develop and test specific intervention strategies that could be integrated seamlessly into current pharmacy practice to enable pharmacists to improve consumer adherence and/or persistence with antihypertensive medications and thus improve their blood pressure control. This study is being carried out as part of a Research Tender from The Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement Research and Development Program.
Possible benefits
The link between blood pressure control and health outcomes is clearly established. The role of pharmacists in monitoring and assisting consumers with medication adherence to achieve desired therapeutic outcomes is also well established. It is anticipated that the proposed blood pressure medication adherence service will assist consumers with hypertension to achieve target blood pressure, which would benefit your patients. The likely benefit to you would be recognition by consumers of the role of pharmacists in the area of disease state management.
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What does the research involve?
You will need to have or to set up an area in the pharmacy where patient consultation can occur privately, participate in an education program in hypertension management (pharmacist and other staff) by self study either alone or in conjunction with a training workshop.
A software application will be integrated into your FRED Dispense program to identify patients who are using or have used antihypertensive medicines in the previous six months. The software will select 20 patients who are using antihypertensive medicines, prioritising patients who started or discontinued an antihypertensive medicine in the previous six months. From these selected patients, it is anticipated that you will be able to recruit 7-10 participants.
Your pharmacy will be randomly allocated to one of two groups. One group will be required to undertake consultations with participants at baseline and three months and six months after the initial consultation. The second group will be required to undertake consultations at baseline and again six months later. In these pharmacies, the software program will also randomly select 7-10 control patients at baseline, whose identity will be concealed from participating pharmacists and the researchers. Data from these patients will be analysed at six months.
At each visit, you will document your assessment and interventions, download information from blood pressure monitors for discussion and collect data on adverse events, use of health services, self care etc. After your patients have all completed their visits, you may be asked to participate in a follow-up survey/interview or focus group to provide feedback on your experience of involvement in the program.
You may be approached to participate in a follow-up interview after completion of the project.
How much time will the research take?
Consultations are estimated to be likely to take an average of one hour each. In addition, you will need to spend time to prepare prior to the consultations and some time after completing data recording. It is estimated that this would take an average of half an hour per consultation.
Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project, apart from the time taken to conduct the consultations.
Payment
To compensate for your time and costs you may incur (e.g. in setting up a suitable environment for consultation), we will be offering $500 per pharmacy for participation.
The group undertaking three consultations will be offered $100 per participant completing all visits. The group undertaking two consultations will be offered $50 per participant completing both visits and $25 per subject in the control group.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time, provided that data already collected is submitted to the researchers.
Confidentiality
All the information provided by you and all the information from your records will be confidential. Neither your nor your patients’ names will appear in any of the results
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants (pharmacist or patients) will not be identifiable in such a report.
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Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. .
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research (CF08/3281 – 2008001602) is being conducted, please contact:
Assoc Prof Kay Stewart Department of Pharmacy Practice Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade Parkville, VIC 3052 Telephone: +61 3 9903 9618 Fax: +61 3 9903 9629; E-Mail: [email protected]
Executive Officer Standing Committee on Ethics in Research Involving Humans (SCERH) Building 3e Room 111 Research Office Monash University VIC 3800 Tel: +61 3 9905 2052 Fax: +61 3 9905 1420 Email: [email protected]
1. Do you use ‘FRED Dispense’ OR ‘Fred Health’ in your pharmacy?
Yes No (ineligible to participate in the study)
2. Are you happy to install a software application (MedeMine) on your dispensing computer to identify patients who are using or have used antihypertensive medicines in the previous six months? (NOTE: This software is used in different states without any problems in speed or compatibility)
Yes No (ineligible to participate in the study)
3. Do you have AT LEAST 40 patients who are currently using or have used ANY ONE OR MORE of the following antihypertensive medicines in the last 6 months?
• Angiotensin Converting Enzyme Inhibitors
• Angiotensin-II Receptor Antagonists
• Calcium Channel Blockers
• Beta Blockers
• Thiazide Diuretics
Yes No (ineligible to participate in the study)
4. Do you have private counselling area within your pharmacy where one-on-one consultation with a patient will be shielded from public eye and ear?
Yes No (There is $500 allocated to each pharmacy to help in securing a private area)
5. As the initial consultation with each patient may take up to one hour, do you have time within your working week to allocate this amount of uninterrupted time to the patients?
Yes No (ineligible to participate in the study)
6. The end of this project will approximately be in February 2010. Are you aware of any possible changes in the pharmacy which may affect your ability to participate in this study for this duration?
Yes (not ineligible, however cautious to include) No
8. Do you have access to MedsIndex? (This can either be already installed on the computer or in disk format. Eligibility of participation is not depended on pharmacies having their own copy of MedsIndex.)
Yes No
9. Will your pharmacy likely participate in the MIRIXA project which will be rolled out by the Pharmacy Guild?
Yes No
10. Does your pharmacy use a SMS reminder for prescriptions service?
Yes No
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Appendix 11: Phase 3 - Assessment of Knowledge form (PCG)
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INCREASING COMMUNITY PHARMACY INVOLVEMENT IN THE PREVENTION OF CARDIOVASCULAR DISEASE
1. Hypertension is defined as blood pressure measurements which are consistently:
a. 120mmHg or greater systolic or 80 mmHg or greater diastolic
b. 120mmHg or greater systolic and 80 mmHg or greater diastolic
c. 140mmHg or greater systolic or 90 mmHg or greater diastolic
d. 140mmHg or greater systolic and 90 mmHg or greater diastolic
2. Which of the following is NOT recommended when measuring a patient’s blood pressure:
a. Making sure the patient is sitting quietly for a few minutes
b. Advising the patient to skip their blood pressure medications on the day of assessment
c. Advising the patient to wait until 2-4 hours after taking antihypertensive medicines before
taking BP at home
d. Raising the patient’s arm so the cuff is at the same height as the heart'
3. Patients are considered at high risk of cardiovascular disease if their five year risk of fatal
or nonfatal cardiovascular risk exceeds:
a. 5%
b. 10%
c. 15%
d. 20%
4. Which of the following drug classes is not considered a preferred antihypertensive agent
for patients over 65 years and with no co-morbidities:
a. Thiazide diuretics
b. Beta blockers
c. ACE inhibitors
d. Calcium channel blockers
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5. If a patient is unresponsive to monotherapy initiated with a single antihypertensive agent,
what course of action should be taken:
a. Add a second agent
b. Increase the dose
c. Increase the dose and add a second agent
d. Withdraw the first drug and initiate an alternative antihypertensive drug
6. Which of the following combinations of drugs is considered safest and most effective in
the absence of complicating factors:
a. ACE inhibitor plus calcium channel blocker
b. ACE inhibitor plus Angiotensin II receptor antagonist
c. ACEI/AIIRA plus K-sparing diuretic
d. Verapamil plus beta-blocker
Mr Smith is a 67 year old retiree who lives alone. He takes some over the counter (OTC) medications for his arthritis. He has a history of depression, but is currently not on any medications for this. He takes Cozaar (losartan) 50 mg in the morning for his high blood pressure (BP). Mr Smith usually takes Cozaar after breakfast, but he has no set routine. He occasionally misses the dose, but he thinks it is not a ‘big deal’. He does not have a home blood pressure monitor.
Mr Smith’s GP is always busy and he sees Mr Smith for barely 10 min every 3 months. The GP is not aware of Mr Smith’s noncompliance and his use of OTC medicines. Mr Smith’s BP has lately been uncontrolled and his GP is considering an increase in the dose of Cozaar. Mr Smith usually gets his prescriptions dispensed at the Getwell pharmacy where you are the pharmacist in-charge.
(Question 7 & 8 refer to this case study)
7. Which of the following is NOT a risk factor by itself for noncompliance in Mr Smith?
a. He is 67 years old
b. He has no set routine for taking his medication
c. His GP is very busy and has little time for discussing compliance issues
d. He has a history of depression, but is currently not on any medications for this
e. He gets no regular feedback about his BP control
8. Which of the following compliance interventions is NOT ideal in Mr Smith?
a. Reminders (SMS or telephone) when refills are due
b. Home blood pressure monitoring
c. Dose administration aid
d. Medication use review
e. Routinisation
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9. Please tell us whether each of the following statements are TRUE OR FALSE
a. Non-persistence refers to the discontinuation of treatment by a patient earlier than intended
by their health professional
b. Adherence (compliance) improves consistently with the severity of the disease
c. Electronic monitoring is the ‘gold standard’ for measuring adherence
10. Motivational Interviewing is
a. Changes imposed on a passive client by an expert
b. Manipulative didactic arguments that maintain control
c. The use of behavioural penalties to elicit changes
d. Achieving change by encouraging intrinsic cognitive-emotional problem-solving
e. None of the above
11. The OARS Model utilises
a. Reflective listening
b. Reflective listening and summarising
c. Open-ended questionning and affirming support
d. Addresses resistance and ambivalence
e. All of the above
12. In the recruitment of patients, after patients have been identified by MedeMine what is the next step?
a. Look at identified patients and exclude those that you know would not be eligble
b. Print individual Expression of Interest (EOI) forms
c. Mark patient as “EOI” returned
d. Print a batch of EOI forms
13. Before you can begin collecting data at baseline, what things must be completed?
a. Indicate in MedeMine that Consent form has been signed
b. Patient Consent form singed by patient
c. Data collection forms printed
d. GP Faxback form returned from GP
e. All of the above
14. Regarding patient prescription reminders, please tell us if each of the statements are TRUE or FALSE
a. Patient can have any combination of reminders (SMS, letter or phone)
b. SMS reminders will be automatically sent by MedeMine
c. MedeMine will automatically ring patients who have chosen phone reminders
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Appendix 12: Phase 3 - Assessment of Knowledge form (UCG)
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INCREASING COMMUNITY PHARMACY INVOLVEMENT IN THE PREVENTION OF CARDIOVASCULAR DISEASE
1. In the recruitment of patients, after patients have been identified by MedeMine what is the next step?
a. Look at identified patients and exclude those that you know would not be eligible
b. Print individual Expression of Interest (EOI) forms
c. Mark patient as “EOI” returned
d. Print a batch of EOI forms
2. Before you can begin collecting data at baseline, what things must be completed?
a. Indicate in MedeMine that Consent form has been signed
b. Patient Consent form singed by patient
c. Data collection forms printed
d. GP Faxback form returned from GP
e. All of the above
3. Please indicate whether each of the following statements is TRUE or FALSE
a. After the baseline appointment if you have identified adherence issues you should not take any action to improve adherence.
b. Despite being in a control group, if the patient has uncontrolled high blood pressure you should refer them to the GP.
c. All recruited patients in the Usual Care Group will receive the project interventions after the 6-month trial
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Appendix 13: Phase 3 – Evaluation of training form (PCG)
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EVALUATION FORM - CVD Training Seminar (Pharmacist Care Group)
Your feedback would be greatly appreciated to help us evaluate the training program. We therefore ask you to fill in this form – your answers will remain anonymous. Please tick the box or circle the number which best describes your opinion and comment as requested. 1. What were the TWO main reasons for your participation in this project?
□ Interest in pharmacy research in general
□ Interest in hypertension
□ Interest in compliance
□ Receiving CPD points
□ Receiving blood pressure monitors for patients
□ Receiving blood pressure monitors for pharmacy
□ Pharmacy payment
□ Helping your customers
□ Other ____________________________________________
2. To what extent did the training day meet your expectations?
Very poorly 1 2 3 4 5 Very well
3. Overall how would you rate the training on the following criteria
a. Relevance of content to your practice Irrelevant 1 2 3 4 5 Relevant
4. How would you rate the relevance to the project of the clinical and practical information provided in the training manual and training sessions? Relevant 1 2 3 4 5 6 7 Irrelevant
5. Overall how confident do you feel in applying the training into practice?
Extremely Confident 1 2 3 4 5 6 7 Not at all confident
6. What other comments and suggestions do you have to improve the training?
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Appendix 14: Phase 3 – Evaluation of training form (UCG)
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EVALUATION FORM - CVD Training Seminar (Usual Care Group)
Your feedback would be greatly appreciated to help us evaluate the training program. We therefore ask you to fill in this form – your answers will remain anonymous. Please tick the box or circle the number which best describes your opinion and comment as requested.
1. What were the TWO main reasons for your participation in this project?
□ Interest in research in general
□ Interest in hypertension
□ Interest in compliance
□ Receiving CPD points
□ Receiving blood pressure monitors for patients
□ Receiving blood pressure monitors for pharmacy
□ Pharmacy payment
□ Helping your customers
□ Other ____________________________________________
2. To what extent did the training day meet your expectations?
Very poorly 1 2 3 4 5 Very well
3. Overall how would you rate the training on the following criteria
4. How would you rate the relevance to the project of the practical information provided in the training manual and training sessions? Irrelevant 1 2 3 4 5 Relevant
5. Overall how confident do you feel in applying the training to practice?
Not at all confident 1 2 3 4 5 Extremely Confident
6. What other comments and suggestions do you have to improve the training?
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Appendix 15: Phase 3 - General Practitioner Letter and Faxback Form
<Pharmacy Name> is participating in a research project with the Faculty of Pharmacy and Pharmaceutical Sciences, Monash University. The aim of this project is to develop and test specific intervention strategies to enable pharmacists to support consumers to improve their adherence and/or persistence with antihypertensive medications and thus improve their blood pressure control.
Pharmacies have been randomly allocated to one of two groups. One group will undertake consultations with participants at baseline, three months and six months after the initial consultation. The second group will undertake consultations at baseline and again six months later. Participants will be provided with a blood pressure monitor either at the start of the project or towards the end of the project (depending on which group they are allocated to) and asked to check their blood pressure at home between visits. The project is supported by the Victorian Divisions of General Practice and has received ethical approval from Monash University’s Standing Committee on Ethics in Research Involving Humans.
To be eligible to participate in the research project, consumers must have a diagnosis of primary hypertension and be on prescribed medication for its treatment. Pharmacists will refer patients to you if problems are detected, such as poorly controlled blood pressure despite good adherence with medications.
One of your patients <Patient Name>, <Patient address> is interested in participating in the research project. Please see attached a copy of the signed consent form from <Patient Name> expressing their interest in participating in the study and giving their permission for you to provide this information to the pharmacist (i.e. confirmation of a diagnosis of primary hypertension; target blood pressure).
I kindly ask that you provide us the requested details (see next page) about <Patient Name>.
If you would like further information about any aspect of the project, please contact me at the pharmacy or Assoc Prof Kay Stewart at the Faculty of Pharmacy and Pharmaceutical Sciences, Monash University on telephone 9903 9618 or email [email protected].
Our pharmacy is carrying out a research project in collaboration with University of Tasmania and Curtin University. This project aims to develop and test pharmacy services to assist and support consumers to achieve the best results from their blood pressure medicines.
We would like to invite you to participate in this project.
This project will require you to meet with your pharmacist two or three times within a 6 month period. As part of the project you will also be provided with a blood pressure monitor for self-monitoring of blood pressure at home. The monitor will be yours to keep after the study provided you meet the project requirements. You will receive it either at the beginning or at the end of the 6 months project, depending on the project group to which you will be allocated.
To help us assess your eligibility to participate in the project, please answer the following:
Have you ever been diagnosed with high blood pressure? Yes No Don’t know
I consent to the pharmacist contacting my General Practitioner to Yes No confirm my diagnosis of high blood pressure and to find and to find out my target blood pressure.
Name: ______________________________________________ Signature:____________________________________________ Date : ________________________________ If you want any further information about this project, please provide your contact details: Name ________________________________________ Address ________________________________________________________________ ________________________________________________________________ Tel: _____________________ Mobile (optional): _____________________ Best time(s) to contact you: ______________________________
NOTE: We will contact you to provide more project details. . Please be assured that requesting more information does not commit you to taking part in theproject.
Please return this form within the week to the pharmacy in the stamped envelope provided, regardless of whether you are interested in participating or not.
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with:
• Dr Johnson George, and Jennifer McDowell from the same department • Kevin McNamara, from the same department and also the Greater Green Triangle University Department of
Rural Health (Flinders and Deakin Universities) • Dr Shane Jackson, Professor Gregory Peterson, Dr Luke Bereznicki, Peter Gee and Angus Thompson, Unit
for Medication Outcomes Research and Education (University of Tasmania) • Associate Professor Jeffery Hughes, School of Pharmacy, Curtin University, WA
• Dr Michael Bailey, Department of Epidemiology and Preventive Medicine, Monash University • Dr Arthur Hsueh, Centre for Health Policy, Programs and Economics, The University of Melbourne
Why did we choose this particular person/group as participants?
Cardiovascular Disease accounts for 39% of deaths of Australian adults. Despite this, patients with common risk factors often receive treatment that is suboptimal. High blood pressure (BP), for example, is an extremely common risk factor, affecting about one third of adults, and is the most common reason for visiting a GP in Australia. Despite the availability of effective treatments, only a quarter of all those diagnosed and half of those taking medication achieve target BP levels.
Lack of adherence to medicines and failure to persist with the taking of medicines are acknowledged as major reasons for uncontrolled blood pressure. Research conducted in Australia and overseas clearly supports an active role of the community pharmacist in management of chronic disease, in collaboration with other health care professionals. Such studies have highlighted opportunities for community pharmacists to provide a range of services to support patients in self-managing their conditions.
You have been approached to participate in this study because dispensing records at your community pharmacy show that you are currently taking medication usually prescribed for the treatment of high blood pressure and you have expressed interest in finding out more about the project after receiving a recent letter from the pharmacy. The researchers do not have access to your contact details, so this Explanatory Statement about the research has been sent to you on our behalf by your pharmacist, who holds your contact details on their dispensing database.
Being in this study is voluntary and you are under no obligation to consent to participation. The service you currently receive from your pharmacy will not be affected by your decision to participate or not.
The aim/purpose of the research
The aim of this project is to develop and test specific services that could be provided through community pharmacies to enable pharmacists to assist and support consumers to get the best results from their blood pressure medicines. This study is being carried out as part of a Research Tender from The Pharmacy Guild of Australia under the Fourth Community Pharmacy Agreement Research and Development Program.
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Possible benefits
The link between blood pressure control and health outcomes is clearly established. It is anticipated that this service will assist you to achieve and maintain target blood pressure, which would benefit your long term health outlook.
What does the research involve?
Your pharmacist will firstly check whether you are eligible to participate in this study. As part of this assessment, your pharmacist will need your permission to ask your general practitioner for some medical information about you. Your pharmacy will be randomly allocated to one of two groups. In one group, consumers will be required to attend appointments with their pharmacists initially and then three months and six months later. In the other group, consumers will attend appointments with their pharmacists initially and then six months later. As part of the study, you will be provided with a blood pressure monitor and asked to check your blood pressure at home.
Should your pharmacist detect any problems related to your health, they will refer you to your general practitioner for further assessment.
You may be approached to participate in a follow-up interview after completion of the project.
How much time will the research take?
Consultations are estimated to be likely to take an average of one hour each. In addition, you will be asked to monitor your blood pressure at home a few times per week.
Inconvenience/discomfort We do not foresee any inconvenience or discomfort from your participation in this project, apart from the time needed for appointments and blood pressure monitoring.
Payment
The blood pressure monitor will be yours to keep. There is no other payment for participating in the study.
Can I withdraw from the research? Participation in this study is voluntary and you may withdraw at any time; however, data already collected at the time of withdrawal will be available to the researchers.
Confidentiality All the information provided by you and all the information from your records will be confidential. Neither your name nor your pharmacist’s or doctor’s name will appear in any of the results.
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Storage of data Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants (pharmacist or patients) will not be identifiable in such a report.
Results If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected].
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research <insert your project number here, i.e. 2006/011> is being conducted, please contact:
Assoc Prof Kay Stewart Department of Pharmacy Practice Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade Parkville, VIC 3052 Telephone: +61 3 9903 9618 Fax: +61 3 9903 9629; E-Mail: [email protected]
Executive Officer Standing Committee on Ethics in Research Involving Humans (SCERH) Building 3e Room 111 Research Office Monash University VIC 3800 Tel: +61 3 9905 2052 Fax: +61 3 9905 1420 Email: [email protected]
Thank you.
Kay Stewart
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Appendix 19: Phase 3 - Baseline Collection Data Form
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Baseline Visit Time start:_______
Section A: General demographics
1. What is your age? _______ years
2. Are you male or female? Male Female
3. Where were you born? Country _______________________
4. What language do you speak mostly to your family? _______________________
5. Was your father born in Australia? Yes No, specify country ______________
6. Was your mother born in Australia? Yes No, specify country ______________
7. Are you of Aboriginal or Torres Strait Islander origin?
Yes, Aboriginal Yes, Torres Strait Islander No
8. What is your highest level of education?
No formal schooling
Primary school
High school
Secondary school
Technical or further educational institution (including TAFE Colleges)
University education
9. What is your marital status?
Married Widowed Cohabiting/Partnered/Defacto
Single Separated Divorced
10. What is your average annual household gross income before tax in Australian dollars?
less than $50,000 $50,000 – $75,000 $75,001 – $100,000
$100,001 – $125,000 $125,001 – $150,000 more than $150,000
11. Do you have an Australian healthcare concession card?
No concession card
Healthcare card
Pensioner concession card
Commonwealth Seniors Health card
Repatriation Health Card specify colour: Gold White Yellow
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Section B: Health
12. Have you ever been told by a doctor that you have the following health conditions? (Tick one or more boxes)
Arthritis Liver disease Eye disease such as glaucoma
Cancer Heart condition such as heart attack, angina or blocked arteries
Dementia Kidney problem Lung condition or asthma
Diabetes Stomach ulcer Depression or mental health condition
Stroke Osteoporosis, or weak or brittle bones HIV or AIDS
Section C: Clinical Measurements
13. How has your blood pressure been recently?
Too low Normal/target Too High Not sure/don’t know
14. Self-reported BP______ / ______ mmHg Not known
15. Do you know what your target blood pressure is?
Yes, specify ______ / ______mmHg No
16. Measured blood pressure:
Date:_____________(dd/mm/yy)
Time:_____________(am/pm)
Arm Circumference: _ _ . _cm
Pulse: Regular Irregular
BP 1: ___ ___/___ ___mmHg Pulse 1: ___ ___ / min
BP 2: ___ ___/___ ___ mmHg Pulse 2: ___ ___ / min
Note: A third BP measure is necessary if the first two readings differ by 10mmHg (systolic) or ≥ 5mmHg (diastolic). Maximum three measurements
BP 3: (if necessary) ___ ___/___ ___ mmHg Pulse 3: ___ ___ / min
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Section D: Your use of medicines
Please list ALL of the medicines you use – including prescription, over the counter, herbal or other supplements.
Medicine name, strength and dose Why are you using this medicine?
How long have you been using this medicine?
Meds
Index score
Do you think this medicine is working?
Do you experience any problems or side effects with using this medicine?
WELL OKAY NOT WELL DON’T
KNOW
YES
(SPECIFY)
NO
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Section D: Your use of medicines
Please list ALL of the medicines you use – including prescription, over the counter, herbal or other supplements.
Medicine name, strength and dose Why are you using this medicine?
How long have you been using this medicine?
Meds
Index score
Do you think this medicine is working?
Do you experience any problems or side effects with using this medicine?
WELL OKAY NOT WELL DON’T
KNOW
YES
(SPECIFY)
NO
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Section D: Your use of medicines (continued)
17. Have you ever had any problems (such as side effects) with any of your medicines?
Yes, specify ________________________________ No
18. How would you rate the complexity/difficulty in using/taking ALL your medicines as prescribed on a scale of 1 (very simple) to 5 (very complex)?
19. Which of the following would you be willing to try if further reduction in your BP becomes necessary? (Tick one or more boxes)
Additional medicine Change of medicine
Higher dose of current medicine(s) Change in lifestyle (e.g. salt or fluid restriction)
20. Do you have any of the following difficulties or problems with your medicines? I have difficulty: (Tick one or more boxes)
Opening containers Swallowing my medicines
Getting to the doctor or pharmacy when my medicines run out
Understanding different brands of the same medicines such as using generics
Reading and understanding labels
Other (please specify _______________________________________________
21. Do you use any of the following to help you remember to use/take your medicines? (Tick one or more boxes)
Alarm beeper Calendar Diary Medicine box (Dosette, Webster)
Medicine list Relative/carer Other _________________________
22. Have you had a Medication Profiling service from a pharmacy in the last 12 months?
Yes, specify when ________________ No
Section E: About your high blood pressure and its management
23. Do you ever forget to take your medicines? Yes No
24. Are you always careful in taking your medicines? Yes No
25. When you feel better do you sometimes stop taking your medicines? Yes No
26. Sometimes, if you feel worse when you take your medicines do you stop taking it? Yes No
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27. For each of the following statements, please tick (����) the box that best corresponds to your beliefs and experiences.
Management means all the things that your doctor has recommended that you do to control your high blood pressure, like taking medicines, losing weight, exercising etc.
Statements
Definitely True
Mostly True
Don’t Know
Mostly False
Definitely False
I have sufficient understanding about high BP
I know what to expect from my BP management
My current management will keep my high BP at bay
I am receiving the best possible management
The management of my high BP is a mystery to me
It is helpful to know the experiences of others with high BP
Natural remedies are safer than medicines
My doctors have limited management options to offer me
My medicines are working
Using any medicine involves some risk
I am on too many medicines
I have a say in the way my high BP is managed
I have sufficient understanding about the options for managing my high BP
My doctors are very knowledgeable
Statements Extremely Quite a bit Moderately Slightly Not at all
I am concerned about the side effects from my medicines
It is unpleasant (e.g. taste, smell) to use some of my medicines
It is physically difficult to handle some of my medicines
I am satisfied with the information my doctors share with me
My doctors are compassionate
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Statements Extremely Quite a bit Moderately Slightly Not at all
Financial difficulties limit my access to the best healthcare
My doctors spend adequate time with me
The management of my high BP disrupts my life
Statements Always Often Sometimes Rarely Never
I get confused about my medicines
I have strict routines for using my regular medicines
I keep my medicines close to where I need to use them
I ensure I have enough medicines so that I don’t run out
I strive to follow the instructions of my doctors
I make changes in the recommended management to suit my lifestyle
I vary my recommended management based on how I am feeling
I put up with my medical problems before taking any action
Section F: About your general wellbeing
For each of the following statements, please tick (�) the alternative that best describes you during the last week.
28. When doing household tasks: (For example, preparing food, gardening, using the video recorder, radio, telephone or washing the car)
I need no help at all.
Occasionally I need some help with household tasks.
I need help with the more difficult household tasks.
I need daily help with most or all household tasks.
29. Thinking about how easily I can get around my home and community:
I get around my home and community by myself without any difficulty.
I find it difficult to get around my home and community by myself.
I cannot get around the community by myself, but I can get around my home with some difficulty.
I cannot get around either the community or my home by myself.
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SOCIAL RELATIONSHIPS
30. Thinking about my relationship with other people:
I have plenty of friends, and am never lonely.
Although I have friends, I am occasionally lonely.
I have some friends, but am often lonely for company.
I am socially isolated and feel lonely.
31. Thinking about my health and my relationship with my family:
My role in the family is unaffected by my health.
There are some parts of my family role I cannot carry out.
There are many parts of my family role I cannot carry out.
I cannot carry out any part of my family role.
PHYSICAL SENSES
32. Thinking about my hearing, including using my hearing aid if needed:
I hear normally.
I have some difficulty hearing or I do not hear clearly. (For example: I ask people to speak up, or turn up the TV or radio volume.)
I have difficulty hearing things clearly. (For example: Often I do not understand what is said. I usually do not take part in conversations because I cannot hear what is said.)
I hear very little indeed. (For example: I cannot fully understand loud voices speaking directly to me.)
33. When I communicate with others: (For example: by talking, listening, writing or signing)
I have no trouble speaking to them or understanding what they are saying.
I have some difficulty being understood by people who do not know me. I have no trouble understanding what others are saying to me.
I am only understood by people who know me well. I have great trouble understanding what others are saying to me.
I cannot adequately communicate with others.
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PSYCHOLOGICAL WELL-BEING
34. Thinking about how I generally feel:
I do not feel anxious, worried or depressed.
I am slightly anxious, worried or depressed.
I feel moderately anxious, worried or depressed.
I am extremely anxious, worried or depressed.
35. How much pain or discomfort do I experience?
None at all.
I have moderate pain.
I suffer from severe pain.
I suffer unbearable pain.
Section G: OVERALL QUALITY OF LIFE with hypertension/heart disease
36. We would like to know the extent to which hypertension/heart disease has affected your quality of your daily life. Using the score of 0 (death) to 100 (perfect health), what is your current quality of life?
Score:_________________
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Section I: Pharmacist Notes page (PCG only)
Issues Identified (e.g. poor adherence, side effects from medicines, concerns about medicines, poor BP
measurement technique, lack of routine):
Recommendations (e.g. Medication Profiling, Home Medicines Review, Referral to GP, Dose Administration Aids,
etc):
Goals set after discussion with the participant (e.g. develop a routine for medicine use, monitor BP daily):
Review date and time:
Checklist
BP measurement technique taught
Discussed adherence issues (if any)
Discussed target blood pressure (if relevant)
Referred patient to GP (if needed)
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Appendix 20: Phase 3 - Three-month Collection Data Form (PCG)
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Follow-up Visit (3 months)
Section A: Clinical Measurements
How has your blood pressure been recently?
Too low Normal/target Too High Not sure/don’t know
Do you know what your target blood pressure is?
Yes, specify ______ / ______mmHg No
Measured blood pressure:
Arm Circumference: _ _ . _cm
Pulse: Regular Irregular
BP 1: ___ ___/___ ___mmHg Pulse 1: ___ ___ / min
BP 2: ___ ___/___ ___ mmHg Pulse 2: ___ ___ / min
Note: A third BP measure is necessary if the first two readings differ by 10mmHg (systolic) or ≥ 5mmHg (diastolic). Maximum three measurements
BP 3: (if necessary) ___ ___/___ ___ mmHg Pulse 3: ___ ___ / min
Download home BP recordings from patient’s home BP monitor and discuss
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Section B: About your high blood pressure and its management.
Do you ever forget to take your medicines? Yes No
Are you always careful in taking your medicines? Yes No
When you feel better do you sometimes stop taking your medicines? Yes No
Sometimes, if you feel worse when you take your medicines, do you stop taking it? Yes No
8. For each of the following statements, please tick (����) the box that best corresponds to your beliefs and experiences.
Statements
Always Often Sometimes Rarely Never
I get confused about my medicines
I have strict routines for using my regular medicines
I keep my medicines close to where I need to use them
I ensure I have enough medicines so that I don’t run out
I strive to follow the instructions of my doctors
I make changes in the recommended management to suit my lifestyle
I vary my recommended management based on how I am feeling
I put up with my medical problems before taking any action
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Section C: Pharmacist Notes page
Issues Identified (e.g. poor adherence, side effects from medicines, concerns about medicines, poor BP
measurement technique, lack of routine):
Recommendations (e.g. Medication Profiling, Home Medicines Review, Referral to GP, Dosette):
Goals set after discussion with the participant (e.g. develop a routine for medicine use, monitor BP daily):
Review date and time:
Checklist
Downloaded home BP recordings
Discussed home BP recordings
Discussed target blood pressure (if relevant)
Reviewed BP measurement techniques
Discussed adherence issues (if any)
Referred patient to GP (if needed)
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Appendix 21: Phase 3 - Six-month Collection Data Form
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Final Visit (6 months)
Time start:________
Section A: Clinical Measurements
1. How has your blood pressure been recently?
Too low Normal/target Too High Not sure/don’t know
2. Do you know what your target blood pressure is?
Yes, specify ______ / ______mmHg No
3. Measured blood pressure:
Arm Circumference: _ _ . _cm
Date:_____________(dd/mm/yy)
Time:_____________(am/pm)
Pulse: Regular Irregular
BP 1: ___ ___/___ ___mmHg Pulse 1: ___ ___ / min
BP 2: ___ ___/___ ___ mmHg Pulse 2: ___ ___ / min
Note: A third BP measure is necessary if the first two readings differ by 10mmHg (systolic) or ≥ 5mmHg (diastolic). Maximum three measurements
BP 3: (if necessary) ___ ___/___ ___ mmHg Pulse 3: ___ ___ / min
Download home BP recordings from patient’s home BP monitor and discuss
(Pharmacist Care group ONLY)
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Section B: Your use of medicines
Please list ALL of the medicines you use – including prescription, over the counter, herbal or other supplements.
Medicine name, strength and dose Why are you using this medicine?
How long have you been using this medicine?
MedsIndex score
Do you think this medicine is working?
Do you experience any problems or side effects with using this medicine?
well Okay Not well
Don’t know yes (specify)
no
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Section B: Your use of medicines
4. Please list ALL of the medicines you use – including prescription, over the counter, herbal or other supplements.
Medicine name, strength and dose Why are you using this medicine?
How long have you been using this medicine?
MedsIndex score
Do you think this medicine is working?
Do you experience any problems or side effects with using this medicine?
well Okay Not well
Don’t know yes (specify)
no
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Section C: About your high blood pressure and its management.
4. Do you ever forget to take your medicines? Yes No
5 .Are you always careful in taking your medicines? Yes No
6. When you feel better do you sometimes stop taking your medicines? Yes No
7. Sometimes, if you feel worse when you take your medicines, do you stop taking it? Yes No
8. For each of the following statements, please tick (����) the box that best corresponds to your beliefs and experiences.
Management means all the things that your doctor has recommended that you do to control your high blood pressure, like taking medicines, losing weight, exercising etc.
Statements
Definitely True
Mostly True
Don’t Know
Mostly False
Definitely False
I have sufficient understanding about high BP
I know what to expect from my BP management
My current management will keep my high BP at bay
I am receiving the best possible management
The management of my high BP is a mystery to me
It is helpful to know the experiences of others with high BP
Natural remedies are safer than medicines
My doctors have limited management options to offer me
My medicines are working
Using any medicine involves some risk
I am on too many medicines
I have a say in the way my high BP is managed
I have sufficient understanding about the options for managing my high BP
My doctors are very knowledgeable
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Statements
Always Often Sometimes Rarely Never
I get confused about my medicines
I have strict routines for using my regular medicines
I keep my medicines close to where I need to use them
I ensure I have enough medicines so that I don’t run out
I strive to follow the instructions of my doctors
I make changes in the recommended management to suit my lifestyle
I vary my recommended management based on how I am feeling
I put up with my medical problems before taking any action
Statements Extremely Quite a bit Moderately Slightly Not at all
I am concerned about the side effects from my medicines
It is unpleasant (e.g. taste, smell) to use some of my medicines
It is physically difficult to handle some of my medicines
I am satisfied with the information my doctors share with me
My doctors are compassionate
Financial difficulties limit my access to the best healthcare
My doctors spend adequate time with me
The management of my high BP disrupts my life
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Section D: About your general wellbeing
For each of the following statements, please tick (�) the alternative that best describes you during the last week.
INDEPENDENT LIVING
9. When doing household tasks: (For example, preparing food, gardening, using the video recorder, radio,
telephone or washing the car)
I need no help at all.
Occasionally I need some help with household tasks.
I need help with the more difficult household tasks.
I need daily help with most or all household tasks.
10. Thinking about how easily I can get around my home and community:
I get around my home and community by myself without any difficulty.
I find it difficult to get around my home and community by myself.
I cannot get around the community by myself, but I can get around my home with some difficulty.
I cannot get around either the community or my home by myself.
SOCIAL RELATIONSHIPS
11. Thinking about my relationship with other people:
I have plenty of friends, and am never lonely.
Although I have friends, I am occasionally lonely.
I have some friends, but am often lonely for company.
I am socially isolated and feel lonely.
12. Thinking about my health and my relationship with my family:
My role in the family is unaffected by my health.
There are some parts of my family role I cannot carry out.
There are many parts of my family role I cannot carry out.
I cannot carry out any part of my family role.
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PHYSICAL SENSES
13. Thinking about my hearing, including using my hearing aid if needed:
I hear normally.
I have some difficulty hearing or I do not hear clearly.
(For example: I ask people to speak up, or turn up the TV or radio volume.)
I have difficulty hearing things clearly. (For example: Often I do not understand what is said. I usually do not
take part in conversations because I cannot hear what is said.)
I hear very little indeed.
(For example: I cannot fully understand loud voices speaking directly to me.)
14. When I communicate with others: (For example: by talking, listening, writing or signing)
I have no trouble speaking to them or understanding what they are saying.
I have some difficulty being understood by people who do not know me. I have no trouble understanding
what others are saying to me.
I am only understood by people who know me well. I have great trouble understanding what others are
saying to me.
I cannot adequately communicate with others.
PSYCHOLOGICAL WELL-BEING
15. Thinking about how I generally feel:
I do not feel anxious, worried or depressed.
I am slightly anxious, worried or depressed.
I feel moderately anxious, worried or depressed.
I am extremely anxious, worried or depressed.
16. How much pain or discomfort do I experience?
None at all.
I have moderate pain.
I suffer from severe pain.
I suffer unbearable pain.
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Section E: OVERALL QUALITY OF LIFE with hypertension/heart disease
We would like to know the extent to which hypertension/heart disease has affected your quality
of your daily life. Using the score of 0 (death) to 100 (perfect health), what is your current quality
of life?
Score:_________________
Section F: Medicine use and expenses in the past 6 months
17. How many times did you visit your family doctor for hypertension/heart condition in the past 6 months?
1. None
2. Yes
If Yes, how many times:_____________
18. Following question 17, on average, how much did you pay out of pocket each time for visiting your family
doctor (including baby sitting, travel, medical and other related cost for the visit)?
AU$ _____________ (Average)
19. Have you made any emergency visit to the hospital for hypertension/heart condition during the past 6
month?
1. None
2. Yes
If Yes, how many times? _________
20. Following question 19, on average how much did you pay out of pocket for the emergency visit each time
(including baby sitting, travel, medical and other related cost for the visit)?
AU$ _________________ (Average)
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21. Have you had any inpatient stay due to hypertension/heart condition during the past 6 months?
1. None
2. Yes
If Yes, how many times? _________
22. Following question 21, on average how much did you pay out of pocket for the inpatient stay each time
(including baby sitting, travel, medical and other related cost for the visit)?
AU$ _________________ (Average)
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Section G: Pharmacist Notes page (PCG only)
Issues Identified (e.g. poor adherence, side effects from medicines, concerns about medicines, poor BP
measurement technique, lack of routine):
Recommendations (e.g. Medication Profiling, Home Medicines Review, Referral to GP, Dose Administration
Aids, etc):
Goals set after discussion with the participant (e.g. develop a routine for medicine use, monitor BP daily):
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records.
I understand that my participation is voluntary and I have been informed of my right to withdraw at any time, provided any data already collected is transferred to the researchers.
I understand that I may be approached to participate in a follow-up interview on completion of the project.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports or publications from the project, or to any other party.
I understand that data will be kept in a secure storage and accessible only to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research.
Participant’s name __________________________________
Signature __________________________________ Date ___/___/_____
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records.
I understand that my participation is voluntary and I have been informed of my right to withdraw at any stage of the project without being penalised or disadvantaged in any way.
I understand that I may be approached to participate in a follow-up interview on completion of the project.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports or publications from the project, or to any other party.
I understand that data will be kept in a secure storage and accessible only to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. I consent to my pharmacist contacting my General Practitioner to confirm my diagnosis of high blood pressure and to find out my target blood pressure.
Participant’s name __________________________________
Signature __________________________________ Date ___/___/_____
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Appendix 24: Phase 3 - Business Case Evaluation Form (PCG)
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Final Visit (6 months) ID________
Business Case Questionnaire
1. If there is a new service package available, say, the pharmacist can help you to better manage
hypertension/heart disease by monitoring blood pressure and providing consultation regularly, how much are
you willing to pay (maximum dollar) for this additional service per month (one to two visits to the pharmacist)?
AU$:____________ per month.
2. How often did you shop at this pharmacy during the past 6 months:
_____: Once a week
_____: Once in every two weeks
_____: Once in every three weeks
_____: Once a month or more
3. During the past 6 months, how much did you spend at this pharmacy during each visit (including medicine and other goods)?
AU$:________________ (average)
4. What is your overall satisfaction with this pharmacy? (1: very unsatisfied to 7: very satisfied)
Level of satisfaction; _____________
5. Please tell us the first thing that comes to your mind about the service of this pharmacy?
Thank you for participating in the Hypertension Adherence Program in PharmacY (HAPPY) Trial. We are keen to hear your feedback about this project. Monash University researchers will be conducting focus groups and interviews with consumers about their experiences. (The focus groups are discussions amongst up to 8 people, led by a member of the research team.) In the focus group or interview we will seek your views about the blood pressure medication adherence program. You may recall that we asked for your permission to contact you in this regard via the consent form that you signed at the beginning of the service.
As you know, all of the information that your pharmacist has been collecting during the service has been de-identified. This means that the University does not have access to your name or contact details. If you are happy to give us feedback, on the service, please complete the details below and give this form to your pharmacist. By signing this form, you are giving your pharmacist permission to provide us with your name and contact telephone number so that we can talk to you further about being involved and make arrangements for participation in an interview or focus group.
If you decide not to participate in the interview or focus group, or if you withdraw, it will not affect the service that you receive from your pharmacist in any way. Your involvement in the interview or focus group is entirely voluntary. Your pharmacist will not receive any information or feedback regarding your participation in the focus group or interview.
The interview is expected to take approximately 20 minutes. The focus group is expected to take approximately 45-60 minutes.
If you require further information or have any other questions please contact Dr Diana Bortoletto at the Faculty of Pharmacy and Pharmaceutical Sciences, Monash University on 1800 798322 (Toll free). If you are happy for your pharmacist to pass your contact details on to the research team at the University please sign below.
Name _________________________________________
Contact number _________________________________
Signature ______________________________________
Date __________________________________________
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Further, we will also be holding separate focus groups and telephone interviews with pharmacists and general practitioners who have been involved in this project. The aim of these focus groups and interviews is to get their direct feedback on the blood pressure service so that we can understand how satisfied they were with the service and if and how it can be improved. Individual patients and their management of blood pressure will not be discussed with the health professionals.
We were wondering whether you would be kind enough to give us details of the doctor with whom you have dealt with the most over the last 6 months, so that we could invite them to speak to us.
General Practitioner Name ______________________________
Contact number _______________________________________
Thank you for your consideration - we look forward to speaking to you about your experiences.
The HAPPY Trial Team
(Pharmacist – please fax completed forms to Diana Bortoletto at 03 99039629)
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin Mc Namara, Jennifer McDowell, and Dr Diana Bortoletto from the same department and Dr Arthur Hsueh from the Centre for Health Policy, Programs and Economics, The University of Melbourne.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because you have been participating in the Hypertension Adherence Program in PharmacY (HAPPY) Trial. This program is funded by the Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement through the Research & Development Grants Program managed by the Pharmacy Guild of Australia. We are seeking feedback on the views of key stakeholder’s (consumers, pharmacists, general practitioners) about the delivery of this service in the community. As part of the evaluation of the HAPPY Trial, Monash University will be conducting focus groups and interviews with consumers who had participated in the intervention arm of the trial. You may recall that we asked for your permission to approach you to be involved in an interview or focus group in the consent form that you signed at the beginning of the service.
The aim/purpose of the research
Monash University will be conducting focus groups and interviews with keystakeholders about their perspective and experiences with the blood pressure adherence program.
Possible benefits
Your feedback will assist with decision making about the future format of community pharmacy antihypertensive medication adherence services.
What does the research involve?
The study involves being interviewed individually either face-to-face or by telephone or participating in a focus group meeting (face-to-face or by teleconference) with up to 8 other people (consumers) who participated in the project. Interviews will be conducted at a mutually convenient time and place. The face-to-face focus group will be held at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville at a time convenient for all participants. The focus group will be conducted by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. Both the interview and the focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants, and later transcribed verbatim. The transcript will be analysed for major themes and concepts. During the focus group or interview, we will be discussing your experiences with the HAPPY trial. We will be exploring areas including your satisfaction with the service, what you have learned about your blood pressure and the usefulness of the service.
How much time will the interview or focus group take?
The interview is expected to take about 20 minutes. The focus group is expected to take approximately 45-60 minutes. We are only asking you to participate in either an interview or a focus group.
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Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
Payment
To compensate for your time, we will be offering you an honorarium of $75.00 in the form of gift vouchers.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for five years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research (project number: CF09/3381 – 2009001825) is being conducted, please contact:
Assoc Prof Kay Stewart Department of Pharmacy Practice Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade Parkville, VIC 3052 Telephone: +61 3 9903 9618 Fax: +61 3 9903 9629; E-Mail: [email protected]
Executive Officer, Human Research Ethics Monash University Human Research Ethics Committee (MUHREC) Building 3e Room 111 Research Office Monash University VIC 3800 Tel: +61 3 9905 2052 Fax: +61 3 9905 3831 Email: [email protected]
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin Mc Namara, Jennifer McDowell, and Dr Diana Bortoletto from the same department and Dr Arthur Hsueh from the Centre for Health Policy, Programs and Economics, The University of Melbourne.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because you and your pharmacy have been participating in the Hypertension Adherence Program in PharmacY (HAPPY) Trial. This program is funded by the Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement through the Research & Development Grants Program managed by the Pharmacy Guild of Australia. We are seeking feedback on the perceptions and experiences of key stakeholders (pharmacists, general practitioners and consumers) with delivery of this service in community pharmacies. As part of the evaluation of the HAPPY Trial, Monash University will be conducting focus groups and telephone interviews with pharmacists who participated in the intervention arm of the trial.
You may recall that we asked for your permission to approach you to be involved in an interview or focus group in the consent form that you signed at the beginning of the service.
The aim/purpose of the research
Monash University will be conducting focus groups and interviews with key stakeholders about their perspective and experiences with the blood pressure adherence program.
Possible benefits
Your feedback will assist with decision making about the future format of community pharmacy antihypertensive medication adherence services.
What does the research involve?
The study involves being interviewed individually either face-to-face or by telephone, or participating in a focus group meeting (face-to-face or by teleconference) with up to 8 other community pharmacists. Interviews will be conducted at a mutually convenient time and place. The face-to-face focus group will be held at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville, at a time convenient for all participants. The focus group will be moderated by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. Both the interview and the focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants.
During the focus group or interview, we will be discussing your experiences with the HAPPY trial. We will be exploring areas including training for and the implementation of the program, how you feel it has helped your patient(s) and whether the service was professionally satisfying.
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How much time will the interview or focus group take?
The interview is expected to take about 20 minutes. The focus group is expected to take approximately 45-60 minutes. We are only asking you to participate in either an interview or a focus group.
Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
Payment
To compensate for your time, we will be offering you an honorarium of $75.00 in the form of gift vouchers.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for five years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research < project number: > is being conducted, please contact:
Assoc Prof Kay Stewart Department of Pharmacy Practice Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade Parkville, VIC 3052 Telephone: +61 3 9903 9618 Fax: +61 3 9903 9629; E-Mail: [email protected]
Executive Officer, Human Research Ethics Monash University Human Research Ethics Committee (MUHREC) Building 3e Room 111 Research Office Monash University VIC 3800 Tel: +61 3 9905 2052 Fax: +61 3 9905 3831 Email: [email protected]
Thank you
Kay Stewart
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Appendix 28: Phase 4 - General Practitioner Explanatory Statement
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November 2009
Explanatory Statement for General Practitioners CCOOMMMMUUNNIITTYY PPHHAARRMMAACCYY IINNVVOOLLVVEEMMEENNTT IINN PPRREEVVEENNTTIIOONN OOFF CCAARRDDIIOOVVAASSCCUULLAARR DDIISSEEAASSEE
My name is Kay Stewart and I am an Associate Professor in the Department of Pharmacy Practice at Monash University. This research is being conducted in association with Dr Johnson George, Kevin Mc Namara, Jennifer McDowell, and Dr Diana Bortoletto from the same department and Dr Arthur Hsueh from the Centre for Health Policy, Programs and Economics, The University of Melbourne.
Why did you choose this particular person/group as participants?
You have been approached to participate in this study because some of your patients have been involved in a new antihypertensive medication adherence program run through community pharmacy, the Hypertension Adherence Program in PharmacY (HAPPY). Fifty-eight community pharmacies and 397 patients across three Australian states have participated in the six-month randomised controlled trial which will be evaluated to assess the effectiveness of the program. The overall project aims to test a specific pharmacist-led intervention package to improve patient adherence with antihypertensive medications through community pharmacies. This program is funded by the Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement through the Research & Development Grants Program managed by the Pharmacy Guild of Australia. We are seeking feedback on the views of key stakeholder’s (general practitioners, pharmacists, consumers) about the delivery of this service in the community. As part of the evaluation of the HAPPY Trial, Monash University will be conducting focus groups and interviews with general practitioners whose patients participated in the intervention arm of the trial. Your contact details were supplied to us by your patient(s) involved in the project.
The aim/purpose of the research
Monash University will be conducting focus groups and interviews with key stakeholders about their perspective and experiences with the blood pressure adherence program.
Possible benefits
The link between blood pressure control and health outcomes is clearly established. The role of pharmacists in monitoring and assisting consumers with medication adherence to achieve desired therapeutic outcomes is also well established. It is anticipated that the blood pressure medication adherence service will assist consumers with hypertension to achieve target blood pressure. Your feedback will assist with decision making about the future format of community pharmacy blood pressure medication adherence services.
What does the research involve?
The study involves being interviewed individually either face-to-face or by telephone or participating in a focus group meeting (face-to-face or by teleconference) with up to 8 other general practitioners. The face-to-face focus group will be held at the Faculty of Pharmacy and Pharmaceutical Sciences at Monash University, 381 Royal Parade, Parkville at a time convenient for all participants. The focus group will be moderated by an experienced facilitator. A note-taker/observer will also be present, but they will not participate in the discussion. Both the interviews and the focus group will be audio-recorded to ensure that we do not miss any valuable information provided by the participants, and later transcribed verbatim. The transcript will be analysed for major themes and concepts. During the focus group or interview, we will be discussing your experiences with the HAPPY Trial. We will be exploring areas including how you feel it has helped your patient(s), your interaction with your local pharmacist providing the service and any other issues that may have affected you.
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How much time will the research take?
The interview is expected to take about 20 minutes. The focus group is expected to take approximately 45-60 minutes. We are only asking you to participate in either an interview or a focus group.
Inconvenience/discomfort
We do not foresee any inconvenience or discomfort from your participation in this project. You have the right to refuse to answer any questions that you consider to be too personal or intrusive, although this is unlikely to occur.
Payment
To compensate for your time, we will be offering you an honorarium of $75 in the form of gift vouchers.
Can I withdraw from the research?
Participation in this study is voluntary and you may withdraw at any time.
Confidentiality
All the information provided by you during the interview or focus group will be confidential. Focus group attendees and the person transcribing the interview will be asked to sign a confidentiality statement. You will be identified only by a code in the transcript. Any information that could reveal the identity of individual participants will be removed prior to inclusion in any reports, conference presentations or scientific publications.
Storage of data
Storage of the data collected will adhere to the University regulations and will be kept on University premises in locked cupboard/filing cabinet and/or password-protected computers for five years and then destroyed. Only members of the research team will have access to the data. A report of the study may be submitted for publication, but individual participants will not be identifiable in such a report.
Results
If you would like to be informed of the aggregate research finding, please contact Kay Stewart on 03 9903 9618 or fax 03 9903 9629 or by e-mail [email protected]. The findings are accessible for 5 years from the date of your participation in this project.
If you would like to contact the researchers about any aspect of this study, please contact the Chief Investigator:
If you have a complaint concerning the manner in which this research <insert your project number here, i.e. 2006/011> is being conducted, please contact
Assoc Prof Kay Stewart Department of Pharmacy Practice Faculty of Pharmacy and Pharmaceutical Sciences 381 Royal Parade Parkville, VIC 3052 Telephone: +61 3 9903 9618 Fax: +61 3 9903 9629; E-Mail: [email protected]
Executive Officer, Human Research Ethics Monash University Human Research Ethics Committee (MUHREC) Building 3e Room 111 Research Office Monash University VIC 3800 Tel: +61 3 9905 2052 Fax: +61 3 9905 1420 Email: [email protected]
Your participation is entirely voluntary and you will not be able to be identified by your
response, which will remain strictly confidential. As was outlined to you in the information and
consent forms that you signed this conversation will be recorded. Is it OK if I turn the recorder
on now?
The purpose of this focus group/interview is to explore your opinions and experiences with the HAPPY Trial.
Patient experience after they have finished the service:
What was your overall experience with HAPPY? Prompts
• What went well?
• What could be improved?
• Which aspects of the service have been most/least useful? Prompts
• Adherence assessment • BP monitoring service from the pharmacy
• Home BP monitor • Discussion of specific blood pressure issues
• Goal setting
• Prescription reminder service
• What aspects of the service have you most/least appreciated?
How and why did you get involved in the Service? Prompts
• Approached by Pharmacists or Pharmacy Assistant • BP monitors an incentive?
• Believe that they had a problem taking their BP medications?
What have you learnt about your BP since participating in the Service? Prompts • How to take my medications • About my BP control and target BP • Blood pressure – the disease • Lifestyle factors
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FULL FINAL REPORT
In general, how do you feel about receiving this Service from your Pharmacist? Prompts • How were your interactions/communications with your Pharmacists e.g:
o Their understanding of your situation o Availability o Easy to understand o Friendliness o Promptness o Environment
Has your relationship with your GP changed due to the Service and how? Who would you prefer to receive this service from?
• Pharmacist, GP or another Health Care Professional? Over the 6 month service you had 3 visits. Do you feel that this was enough visits with your Pharmacist? Would you have preferred more or less visits over this time period?
Business Case
Community pharmacists’ involvement in enhancing patient compliance may generate other positive effects on the society, meaning extra benefits to the society as a whole in addition to the patient. I would like to discuss that further and perhaps try to estimate or measure it.
Other than the benefits to the patients, what extra benefits do you believe that this service can generate? Prompts: • To the health sector in Australia? e.g. release medical workforce and capital for other medical treatment…etc. • To other sectors in Australia? e.g. reduce the resource burden to non-health part of the society such as transportation, education, legal and housing…etc. • To the primary physicians? e.g. increase income by team care arrangements between GP & pharmacists
• To the pharmacists? e.g. increase in job satisfaction and reduce in job turn over…etc. • To the pharmacy? e.g. increase in other business revenue to the pharmacy, …etc. • To others?
Which of the above benefits is/are likely to be the largest?
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FULL FINAL REPORT The Future In the future, if this Service was offered to many more people with high blood pressure, how do you think they should be recruited? Prompts
• Exclusion or inclusion of BP monitor, possibly buying own monitor How much demand do you think there is for a Service like this in community pharmacy?
How important do you think this Service is for people with high blood pressure in the community?
Should this Service be available to patients on a regular basis?
Would you continue to use this Service if it was available long term? Prompts
• How often do you think you would you need to visit the pharmacy?
• How long should the Service run for? Would it be a short term Service or indefinite? • By appointment or drop in?
How do you think the Service could be improved for patients in the future?
Before we wrap up, is there anything else you would like to add?
The purpose of this focus group/interview is to explore your opinions and experiences with the HAPPY Trial.
Pharmacist experience
What has been your overall experience with the HAPPY trial? Prompts
• What went well?
• What could be improved?
How well did the training equip you to deliver the service? What worked particularly well/helped to prepare you? Were there any gaps in the training? What did not work well? Prompts
What has been your experience in recruiting patients? Prompts
• Easy or difficult (including use of Medemine compared to other modes) • What barriers, if any did you experience?
• Time involved in recruitment & preparation
• Number of patients – right or too many or too few
• BP monitor to patients an incentive?
• Enthusiasm of patients?
How easy or difficult has it been to implement the HAPPY service in your pharmacy? Prompts • What made it easy to implement? (facilitators) • What difficulties did you experience? (barriers) • Have there been any issues with competing priorities within the pharmacy?
• Have you made any changes to your pharmacy operations? � Roster � Staff � Routine � Layout
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FULL FINAL REPORT
What did you think of the service protocol now that you have tried it? Prompts
• What worked well/not so well?
• Time involvement in recruiting, preparation and appts
• Any suggestions for improvement?
What was the average time you spent with a patient during a HAPPY visit? Prompts
• Baseline c.f. 3 and 6 month follow-ups
• Amount of additional time spent c.f. usual hypertensive patients (in quantity)
What did you think of having 3 visits in 6 month? Prompts
• Enough time to get patients to understand?
• Would you have preferred more or less visits?
• Interference with workflow?
Pharmacist’s perspective of patient’s experience
Thinking about the service from your patient’s perspective, how do you think the service has been received by your patients so far? Prompts
• Which aspects of the service have been most/least useful from the patient’s perspective?
• What aspects of the service have been most/least appreciated by patients?
• Have you had any issues with patients being unwilling to return for further visits?
What have been the most and least useful parts of the service for your patients? Prompts
• Adherence assessment • BP monitoring service through pharmacies
• Home BP monitor & technique of taking BP
• Discussion of specific blood pressure and medication issues
• Prescription reminder service
• Interaction with pharmacist
How do you think the Service could be improved for patients in the future?
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FULL FINAL REPORT
GP/Specialist interaction with the Service
Have you had contact with GPs as a direct result of your involvement with HAPPY? If so, in what ways? Prompts
• Initial contact at the beginning o Fax, phonecall o Further correspondence afterwards o Practice Manager o Referral of patients to GP o Written Feedback to GPs
Are you aware if any GPs initiated blood pressure services for your HAPPY patients during the service? Prompts • Change of medication treatment • GP management plan • HMR
What, if any, impact has your involvement with HAPPY had on your professional relationship with local GPs? Overall, what do you think that GPs thought of the HAPPY service?
Business Case
Community pharmacists’ involvement in enhancing patient compliance may generate other positive effects on the society, meaning extra benefits to the society as a whole in addition to the patient. I would like to disucss that further and perhaps try to estimate or measure it
Other than the benefits to the patients, what extra benefits do you believe that this service can generate? Prompts:
• To the health sector in Australia? e.g. release medical workforce and capital for other medical treatment…etc. • To other sectors in Australia? e.g. reduce the resource burden to non-health part of the society such as transportation, education, legal and housing…etc. • To the primary physicians? e.g. increase income by team care arrangements between GP & pharmacists
• To the pharmacists? e.g. increase in job satisfaction and reduce in job turn over…etc. • To the pharmacy? e.g. increase in other business revenue to the pharmacy, …etc. • To others?
Which of the above benefits is/are likely to be the largest?
193
FULL FINAL REPORT Other impacts
What other spinoffs, if any, have you experienced so far as a result of offering the service? Prompts
• Business (covered above too) • Demands for other services • Invitation to participate in other professional activities e.g. seminars, committees etc.
The Future
How much demand do you think there is for a service like this in community pharmacy?
How do you think this service could be improved in the future? Prompts:
• Duration of service (number of services and length of service)
How important do you think this service is for people with high blood pressure in the community?
Would you continue to provide this service if it was ongoing?
Before we wrap up, is there anything else you would like to add?
THANK YOU FOR YOUR PARTICIPATION
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FULL FINAL REPORT
Appendix 31: Phase 4 - General Practitioners Focus Group/Interview Guide
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FULL FINAL REPORT
HAPPY Trial General Practitioner Feedback – Focus Group / Interview Guide (Post RCT)
After the 6 month Service has been completed
Starting the focus group/interview
The purpose of this focus group/interview is to explore your opinions and experiences with the HAPPY Trial.
GP experience
How were you notified about your local community Pharmacist’s participation in the HAPPY trial? Prompts
• Division of General Practice
• Letter/Fax from Pharmacist • Phone call / visit from Pharmacist • Your patient was referred to you as part of HAPPY
What would be your preferred method of notification about such a Service?
What has been your overall experience with the HAPPY trial?
Prompts
• What went well?
• What could be improved?
• Context: Did they know about it?
What follow-up occurred after the initial contact between you and the Pharmacist, if anything? Prompts • Personal communication between yourself and the Pharmacist • Written communication between yourself and the Pharmacist • Referral of patients without contact by pharmacist
Did you initiate any services for hypertension for your HAPPY patients? Prompts • Change in medication • GP management plan • HMR
What, if any, impact has it had on your professional relationship with your local community Pharmacist(s)? Prompts
• Enhanced communication
• More direct contact • Onflowing effect to other patients not involved in this trial • Any negative outcomes?
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FULL FINAL REPORT How do you think HAPPY can assist you or compliment your management of the patient with hypertension? How can it impact on your practice in practical terms? Prompts
• Is adherence a priority issue? • Do they feel GPs can deal with it themselves?
GP’s perspective of patient’s experience
Thinking about the service from your patient’s perspective, how do you think the service has been received by your patients so far? Prompts
• Which aspects of the service have been most/least useful from the patient’s perspective?
• What aspects of the service have been most/least appreciated by patients?
Business Case
Community pharmacists’ involvement in enhancing patient compliance may generate other positive effects on the society, meaning extra benefits to the society as a whole in addition to the patient. I would like to discuss that further and perhaps try to estimate or measure it
Other than the benefits to the patients, what extra benefits do you believe that this service can generate? Prompts: • To the health sector in Australia? e.g. release medical workforce and capital for other medical treatment…etc. • To other sectors in Australia? e.g. reduce the resource burden to non-health part of the society such as transportation, education, legal and housing…etc. • To the primary physicians? e.g. increase income by team care arrangements between GP & pharmacists
• To the pharmacists? e.g. increase in job satisfaction and reduce in job turn over…etc.
• To the pharmacy? e.g. increase in other business revenue to the pharmacy, …etc. • To others?
Which of the above benefits is/are likely to be the largest?
197
FULL FINAL REPORT
The Future How do you think the Service could be improved for patients in the future? How much demand do you think there is for a service like this in community pharmacy?
Before we wrap up, is there anything else you would like to add?
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio- recorded Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio- recorded Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, without being penalised or disadvantaged in any way. I understand that any data that the researcher extracts from the focus group or interview audio-recordings or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-recordings or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio-recorded Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio- recorded Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, without being penalised or disadvantaged in any way.
I understand that any data that the researcher extracts from the focus group or interview audio-recordings or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-recordings or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
Signature ______________________________________
Date ___/___/_____
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FULL FINAL REPORT
Appendix 34: Phase 4 - General Practitioner Consent Form
NOTE: This consent form will remain with the Monash University researcher for their records
I agree to take part in the Monash University research project specified above. I have had the project explained to me, and I have read the Explanatory Statement, which I keep for my records. I understand that agreeing to take part means that:
1. I agree to be involved in a focus group Yes No
2. I agree to allow the focus group to be audio-recorded Yes No
3. I agree to be interviewed by the researcher Yes No
4. I agree to allow the interview to be audio-recorded Yes No
5. I agree to make myself available for a further interview if required Yes No
I understand that my participation is voluntary, that I can choose not to participate in part or all of the project, and that I can withdraw at any stage of the project, without being penalised or disadvantaged in any way.
I understand that any data that the researcher extracts from the focus group or interview audio- recordings or transcripts for use in reports or published findings will not, under any circumstances, contain names or identifying characteristics.
I understand that any information I provide is confidential, and that no information that could lead to the identification of any individual will be disclosed in any reports on the project, or to any other party.
I understand that data from the focus group or interview audio-recordings or transcripts will be kept in a secure storage and accessible to the research team. I also understand that the data will be destroyed after a five year period unless I consent to it being used in future research. Participant’s name _____________________________________
