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Planning, Organising,Implementing andSustaining Patient Safety

International Forum on Quality and Safety in Healthcare

Gothemburg – Half-day course M4 / M8

April 12, 2016

Carol Haraden,Frank Federico,Anthony Staines

Carol Haraden, PhD,Vice President, Institute

for HealthcareImprovement (IHI)

Anthony Staines, Ph.D.Patient Safety ProgramDirector, Fédération des

hôpitaux vaudois,Switzerland

Professeur associé, IFROSS,University of Lyon 3, France

International Forum on Quality and Safety in Healthcare

Gothenburg

April 12, 2016

The presenters have nothing to disclose.

Frank Federico, RPh,

Executive Director,Strategic Partners,

Institute for HealthcareImprovement, USA

Harm in Healthcare :fighting Patient SafetystagnationAnthony Staines, Ph.D.Patient Safety Program Director, Fédération deshôpitaux vaudois, SwitzerlandProfesseur associé, IFROSS, University of Lyon 3,France

Gothemburg,April 12, 2016

Adverse Event - definition

“An unintended injurycaused by medical managementrather than by the disease process.The injury is sufficiently serious tolead to prolongation ofhospitalisation or temporary orpermanent impairment or disability inthe patient.”

Harvard Medical Practice Study(1990)10

An incident which resulted in harm toa patient

WHO – International Classificationfor Patient Safety

NCC MERP Index Value

F-I =>

E-I =>

Studies of Harm in Hospitals

Study Year ofreview

Number ofreviewed stays

% of staysincluding AE

Deaths (%of AE)

Harvard Med PracticeStudy (US)

1984 30121 3.7 13.6

Utah-Colorado 1992 14700 2.9 6.6

Australia 1992 14179 16.6 4.8

UK 1999 1014 10.8 8.2

Denmark 1998 1097 9.0 4.9

New Zealand 1998 6579 11.2 4.5

Canada 2000 3745 7.5 15.9

Sweden 2004 1967 12.3 4.1

Netherlands 2004 7926 5.7 7.6

Spain 2005 5908 9.3 4.4

Nonetheless, despite more than a decade of focus onimproving patient safety in the United States, the current ratesof adverse events among inpatients at three leading hospitalsare still quite high for 33.2 percent of hospital admissions foradults.

6Classen, D. C., Resar, R., Griffin et al. (2011). 'Global trigger tool' shows that adverse events in hospitals may be tentimes greater than previously measured. Health Aff (Millwood), 30(4), 581-589.Office of the Inspector General(2010). Adverse Events in Hospitals: National Incidence Among Medicare Beneficiaries:Department of Health and Human Servicesde Vries, E. N., Ramrattan, M. A., Smorenburg, et al. (2008). The incidence and nature of in-hospital adverse events: asystematic review. Qual Saf Health Care, 17(3), 216-223.

Adverse Event - definition

“An unintended injurycaused by medical managementrather than by the disease process.The injury is sufficiently serious tolead to prolongation ofhospitalisation or temporary orpermanent impairment or disability inthe patient.”

Harvard Medical Practice Study(1990)10

An incident which resulted in harm toa patient

WHO – International Classificationfor Patient Safety

NCC MERP Index Value

F-I =>

E-I =>

1 patient in 10

1 patient in 3

Results:

•A total of 630 individuals (50.2% physicians, 49.8% nurses)participated. Among them, 30% of physicians (95% confidenceinterval [CI] 25%-35%) and 16.6% of nurses (95% CI 12%-21%)reported that at least 1 of the incidents occurred daily or weeklyin their offices (c2 16.1, P <.001).

•On average, each responder reported a total of 92 incidentsduring the preceding 12 months.

9

The most robust studies suggest that1–2% of consultations are associatedwith an adverse event in primary care.In out-of-hours care, the rate is about2%.

19.04.2016

• The AE rate was 13.2 per 100 home care cases [95% confidence interval (CI):

10.4–16.6%, standard error 1.6%].

• 32.7% (20 of 61 AEs) of the AEs were rated as having >50% probabilityof preventability;

• 6 deaths (10.9% of patientswith an AE; 1.4% of allpatients)

Improvement, worsening orstagnation in Patient Safety ?

Preliminary estimates for 2013 show a further 9percent decline in the rate of hospital-acquiredconditions (HACs) from 2012 to 2013, and a 17percent decline, from 145 to 121 HACs per1,000 discharges, from 2010 to 2013.

A cumulative total of 1.3 million fewer HACswere experienced by hospital patients over the3 years (2011, 2012, 2013) relative to thenumber of HACs that would have occurred ifrates had remained steady at the 2010 level.

We estimate that approximately 50,000 fewerpatients died in the hospital as a result of thereduction in HACs, and approximately $12billion in health care costs were saved from2010 to 2013.

December 2, 2014

From 2010 through 2014, the overall rate of hospital-acquired conditions declined 17%,from 145 to 121 per 1,000 hospital discharges.

Among the most frequent HACs, between 2010 and 2014, the rate of pressure ulcersdecreased the most, from 40.3 per 1,000 discharges to 30.9 per 1,000 discharges

Agency for Healthcare Research and Quality (AHRQ), Medicare Patient Safety Monitoring System, 2010-2014;Healthcare Cost and Utilization Project, Nationwide Inpatient Sample, 2010-2013; Centers for DiseaseControl and Prevention, National Healthcare Safety Network, 2010-2013.

14Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates ofpatient harm resulting from medical care. N Engl J Med. Nov 25;363(22):2124-2134.

15Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates ofpatient harm resulting from medical care. N Engl J Med. Nov 25;363(22):2124-2134.

16Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates ofpatient harm resulting from medical care. N Engl J Med. Nov 25;363(22):2124-2134.

France : Study of Patient Harm2004 vs 2009

Adverse Events (2004) Adverse Events (2009)

OR a

CI at95 %

Patientdays(PD)

AE AE/1000 PD

(‰)

CI at95 %

Patientdays

AE AE/1000 PD

(‰)

CI at95 %

35234 255 7.2 [5,7-8,6] 31663 214 6.2 [5,1-7,3] 0,93 c [0,68-1,27]

Vincent, Ch., Amalberti, R., Safer Healthcare, Strategies for the Real World, Springer, 2016

Still a challenge

Major progress has been made in assessing the nature andscale of harm to patients in many countries

A considerable number of interventions of different kinds haveshown that errors can be reduced and processes made morereliable.

The most safety improvements so far demonstrated havebeen those with a strong focus on a core clinical issue and arelatively narrow timescale. It has proved very much moredifficult to improve safety across whole organisations

Improving safety at a population level has been even morechallenging and findings have generally been disappointing.

Vincent, Ch., Amalberti, R., Safer Healthcare, Strategies for the Real World, Springer, 2016

Questions for discussion

Why, despite increased awareness, numerous nationaland regional programs, new research, is Patient Safetystagnating ?

What could be actions to improve or accelerate PatientSafety improvement in your organization ?

Discussion

The improvement threshold phenomenon

23

The fantasy The literature

3 case studies ofleading organizations

The investment threshold

March 8, 200724

FindingsFactors used byleading QIprograms to cometo improved patientresults

Financial resources

PLANdesign

Inspiring vision. Focusedand meaningful strategy

Strategy spread

Prioritizing without exclusion

Dedicated organizationalstructure

Room for bottom-upwithin strategic frame

Credible leader

Adjusted informationsystemsAmbitions education

Quality as a globalbusiness strategy

Identify, analyze,improve processes.

Motivating leaders, no dependency

Inspiring leadership style

Centralize process andoutcome evaluation data

Constant feedbackto professionals

Assess patientsatisfaction

ACTImprove

Program managementmeets clinicians.

Goals, action plan

Culture of evidence-baseddecision making

BuildInfrastructure

& Capacity

Programlogistics

Measurementsystems

Informationsystems

Physical symbolof QI program(e.g.. institute)

Size (volume)Integration

Culture:- goodwill

- measurement- evidence-based- learningorganization

Outstanding ambition

Stable political and economic context

National context stimulatingclinical quality improvementand measurement

Move your dot

Rapid intervention teams

Quality management systems

Joiningcollaboratives

Environment characteristics

System characteristics

Resources

Quality program organizationEducation

Leadership development

Strategy spread

DOimplement

Identify, analyze,improve processes.

Prioritiesmaintained during crises

Stability of gen. managementand program management

Choosing tools compatible withstrategy and culture

CHECKmeasureevaluate

Consistent steering

Crescendo over 15/20 years1.- design, raise awareness

2.- building infrastructure3.- implementing

Motivating leaders, no dependency

Inspiring leadership style

Staines, A. (2007). The relationbetween quality improvementprogams and results for patients).Doctoral dissertation, Universityof Lyon 3, Lyon.

March 8, 200725

FindingsFactors used byleading QIprograms to cometo improved patientresults Build

Infrastructure& Capacity

Programlogistics

Measurementsystems

Informationsystems

Physical symbolof QI program(e.g.. institute)

Culture:- goodwill

- measurement- evidence-based- learningorganization

Quality program organizationEducation

Leadership development

Prioritiesmaintained during crises

Stability of generalmanagement and program

managementChoosing tools compatiblewith strategy and culture

Staines, A. (2007). The relationbetween quality improvementprogams and results for patients).Doctoral dissertation, Universityof Lyon 3, Lyon.

Amalberti, R. Translating concepts into field reality, BMJ-IHI International Forum, April 2014

CMS recently launched Partnership for Patients, an ambitiousnational effort designed to substantially reduce 9 types ofpreventable harm and hospital readmissions.

These harms include adverse drug events, catheter-associated urinary tract infections, central line– associatedbloodstream infections, fall injuries, pressure ulcers, surgicalsite infections, venous thromboembolisms, ventilator-associated pneumonia, and obstetrical adverse events.

Thousands of hospitals have agreed to participate and choseto focus on several harms because it was beyond theircapacity to simultaneously address all 9 types of harm.

The dilemma is that most patients are at risk of most of the 9harms and other harms, including loss of dignity and a senseof respect for their values. Yet patients can expect physiciansto focus harm-reduction efforts on just a few of these harms.Health care is addressing these harms as if each type occursin isolation.

This reaction has occurred because it is too burdensome toattempt to reduce multiple harms at the same time. The“siloing” of preventing patient harm is inefficient. Health careneeds a different approach to reducing patient harm.

For instance, patients receiving mechanical ventilation in theICU are at risk of 8 of the 9 harms on the CMS list, such ascentral line–associated bloodstream infections, ventilator-associated pneumonia, and venous thromboembolism.Mechanically ventilated patients are also susceptible to harmsnot included on the CMS list, such as delirium, diagnosticerrors, and air embolism.It is time for the science of health care delivery to mature andembrace systems engineering. It is time for health care toembrace the compelling goal of reducing preventable patientharm. By systematically addressing all the known harmspatients may experience, clinicians may realize this goal (…).

Resilience engineering

Resilience is the intrinsic ability of a system to adjust itsfunctioning prior to, during, or following changes anddisturbances, so that it can sustain required operationsunder both expected and unexpected conditions.

A practice of Resilience Engineering / Proactive Safety

Management requires that all levels of the organizationare able to:

Learn from past events, understand correctly what happened and why

Respond to regular and irregular conditions in an effective, flexiblemanner,

Monitor short-term developments and threats; revise risk models

Anticipate long-term threats and opportunities

Erik Hollnagel, Safety Culture, Safety Management, and Resilience Engineering2009

Two views of safety managementMoving to Patient Safety 2

Erik Hollnagel, Safety Culture, Safety Management, and Resilience Engineering2009

Classical safety management uses trivial(structural) models. The aim is to reduce thenumber of adverse events (the visible).Efforts focus on avoiding that somethinghappens again (“fixing weaknesses,”prevention, protection).

Resilience management uses non-trivial(functional) models. The aim is to improve theability to succeed under varying conditions.Efforts focus on enhancing the organisation’sability to respond, monitor, anticipate, and learn(the visible and invisible).

Yu A, Flott K, Chainani N, Fontana G, Darzi A. Patient Safety 2030. London, UK: NIHR Imperial PatientSafety Translational Research Centre, 2016.

Four pillars of a safety strategy:

A systems approach. The approach to reduce harm must beintegrated and implemented at the system level.

Culture counts. Health systems and organisations must trulyprioritise quality and safety through an inspiring vision andpositive reinforcement, not through blame and punishment.

Patients as true partners. Healthcare organisations mustinvolve patients and staff in safety as part of the solution, notsimply as victims or culprits.

Bias towards action. Interventions should be based onrobust evidence. However, when evidence is lacking or stillemerging, providers should proceed with cautious, reasoneddecision-making rather than inaction.

Yu A, Flott K, Chainani N, Fontana G, Darzi A. Patient Safety 2030. London, UK: NIHR Imperial PatientSafety Translational Research Centre, 2016.

Emerging threats to Patient Safety

• Increasingly complex cases

• Increasingly complex care

• Budget constraints

• Antimicrobial resistance.

Yu A, Flott K, Chainani N, Fontana G, Darzi A. Patient Safety 2030. London, UK: NIHR Imperial PatientSafety Translational Research Centre, 2016.

Integrated approach to Patient Safety

• Systems-based

• Focused on culture

• Patient- and staff-centred

• Evidence-based

Yu A, Flott K, Chainani N, Fontana G, Darzi A. Patient Safety 2030. London, UK: NIHR Imperial PatientSafety Translational Research Centre, 2016.

Move from piecemeal to total systems approach

Despite demonstrated improvement in specific problem areas, such as hospital-acquired infections, the scale of improvement in patient safety has been limited.

Though many interventions have proven effective, many more have beenineffective.

The health care system continues to operate with a low degree of reliability.

To Err Is Human : the expectation at the time was substantial, permanentimprovement.

Next 15 years : it has become increasingly clear that safety issues are far morecomplex—and pervasive—than initially appreciated.

Patient safety requires an overarching shift from reactive, piecemealinterventions to a total systems approach to safety.

It means leadership consistently prioritizing safety culture and the wellbeing andsafety of the health care workforce.

National Patient Safety Foundation, Free from Harm, 2015

Recommendations

1. Ensure that leaders establish and sustain a safety culture

2. Create centralized and coordinated oversight of patient safety

3. Create a common set of safety metrics that reflect meaningfuloutcomes

4. Increase funding for research in patient safety andimplementation science

5. Address safety across the entire care continuum

6. Support the health care workforce

7. Partner with patients and families for the safest care

8. Ensure that technology is safe and optimized to improve patientsafety

National Patient Safety Foundation, Free from Harm, 2015

Vincent, Ch., Amalberti, R., Safer Healthcare, Strategies for the Real World, Springer, 2016

New challenges

Safety is, in a number of respects, a constantly movingtarget. The perimeter has expanded over time.

Patient safety has evolved and developed in the contextof hospital care. New approaches will be required inmore distributed forms of healthcare delivery.

People live longer with chronic conditions which wereonce fatal. This bring new challenges to home andprimary care.

Rising healthcare costs, rising standards and increaseddemand will place huge pressures on healthcaresystems which will increase the likelihood of seriousbreakdowns in care.

Vincent, Ch., Amalberti, R., Safer Healthcare, Strategies for the Real World, Springer, 2016

New thinking required

We assume high quality healthcare punctuated by occasionalsafety incidents and adverse events; this as a vision of safetyfrom the perspective of healthcare professionals. We need toalso understand risk and harm through the patient’s eyes

Viewing safety through the patient’s eyes has the immediateconsequence that we need to view safety in the context of thepatient journey.

We have very limited safety strategies for dealing with the day today realities of healthcare. People adapt and cope, but on anindividual basis rather than with a considered team basedstrategy. Team approaches have to be developed for suchsituations.

Vincent, Ch., Amalberti, R., Safer Healthcare, Strategies for the Real World, Springer, 2016