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ICT CIP – Competitive and Innovation Programme

UNIversal solutions in TElemedicine Deployment for European HEALTH care

(Grant Agreement N 325215)

Deliverable D7.6 Intermediate Trial Report - COPD

Version 1.0 Work Package: WP7

Version & Date: v1.0 / 16th March 2015

Deliverable type: Report

Distribution Status: Public

Author: Dr Keir Lewis and Dr Daniel Warm

Reviewed by: John Oates

Approved by: Janne Rasmussen

Filename: D7.6 v1.0 U4H Intermediate Trial Report - COPD

Abstract

This interim trial report describes the key aspects of the COPD arm of the United4Health Project in each of the six trial sites across Europe, namely Wales and Scotland in the UK; Galicia in Spain Berlin in Germany; and both North and South Norway.

Key Word List

AECOPD, Acute Exacerbation of Chronic Obstructive Pulmonary Disease; COPD, Chronic Obstructive Pulmonary Disease; TMon, Telemonitoring

D7.6 Intermediate Trial Report - COPD

Public Page 2 of 65 v1.0 / 16th March 2015

Executive Summary

This interim trial report describes the key aspects of the Chronic Obstructive Pulmonary Disease (COPD) arm of the United4Health Project in each of the six trial sites across Europe, namely Wales and Scotland in the UK; Galicia in Spain Berlin in Germany; and both North and South Norway.

COPD is a respiratory disease that is a major cause of morbidity and mortality across Europe, and is characterised by frequent (re)-admissions to hospital. Telemonitoring (Tmon) for COPD has been associated with reduced emergency admissions and other healthcare contacts; however, what is less clear is:

What should be the target patient population?

Which measurements are most appropriate and useful, e.g. spirometry, pulse oximetry, temperature, symptom management questions and quality of life questions?

The added value of video consultation.

The optimal duration for comprehensive telemonitoring on an ongoing basis.

How could telemonitoring be better utilised to reflect an individual patient’s health status at any given time

Key points to note within this interim report include:

All trial sites have implemented TMon interventions that aim to address these key questions.

All sites have implemented technical solutions of similar types, but their use within the healthcare setting differs by country.

All sites are either currently recruiting patients or are following up patients using TMon to manage their COPD.

All patients recruited must have been a patient discharged from hospital following an acute exacerbation of their COPD (AECOPD).

It should be noted that a number of key sections cannot be completed as part of this interim report but will be described in the final report.



Change History

Version History:

0.1 28th November 2014 Initial draft 0.2 2nd December 2014 0.3 21st December 2014 0.4 14th January 2015 0.5 3rd February 2015 1.0 16th March 2015 Version Changes 0.1 Initial Table of Contents, derived from MAST domains 0.2 Revised with information supplied from Wales 0.3 Revised with information supplied from South Norway 0.4 Revised with information supplied from Scotland 0.5 Revised with information supplied from Galicia 1.0 Version for issue Outstanding Issues



Table of Contents

EXECUTIVE SUMMARY 2

CHANGE HISTORY 3

TABLE OF CONTENTS 4

1. INTRODUCTION 7

1.1 Purpose of this document 7

1.2 Structure of the document 7

1.3 Glossary 7

2. DOMAIN 1: DESCRIPTION OF THE HEALTH PROBLEM AND CHARACTERISTICS OF THE APPLICATION 8

2.1 The health problem of the patients 8

2.2 Burden of the disease 8

2.3 Current management 8 2.3.1 Scotland 8 2.3.2 Wales 10 2.3.3 Southern Norway 11 2.3.4 Galicia 12 2.3.5 North Norway 13 2.3.6 Berlin 14

2.4 Use of the technical application 15 2.4.1 Scotland 15 2.4.2 Wales 16 2.4.3 Southern Norway 16 2.4.4 Galicia 17 2.4.5 North Norway 18 2.4.6 Berlin 18

2.5 Technical characteristics 23 2.5.1 Scotland 25 2.5.2 Wales 28 2.5.3 Southern Norway 30 2.5.4 Galicia 31 2.5.5 North Norway 34 2.5.6 Berlin 34

2.6 Requirements 34 2.6.1 Scotland 34 2.6.2 Wales 37 2.6.3 Southern Norway 40 2.6.4 Galicia 41 2.6.5 North Norway 42 2.6.6 Berlin 42

3. DOMAIN 2 AND 3: SAFETY AND CLINICAL EFFECTIVENESS 43

3.1 Methods: Trial design 43

3.2 Methods: Participants 44 3.2.1 Scotland 44 3.2.2 Wales 45



3.2.3 Southern Norway 45 3.2.4 Galicia 45 3.2.5 North Norway 45 3.2.6 Berlin 45

3.3 Methods: Interventions 45

3.4 Methods: Outcomes 45

3.5 Methods: Sample size 46

3.6 Methods: Statistical methods 47

3.7 Results: Participant flow 47

3.8 Results: Baseline data 48

3.9 Results: Estimation of outcomes 49

3.10 Results: Ancillary analyses 50

3.11 Results: Adverse events 50

3.12 Discussion of findings 51 3.12.1 Scotland 51

4. DOMAIN 4: PATIENT PERSPECTIVES 52

4.1 Aim of study and the instrument used. 52

4.2 Data collection 53

4.3 Subscales 53

4.4 Results from CFA 53

4.5 Effects of explanatory variables 53

4.6 Discussion of findings 53

5. DOMAIN 5: ECONOMIC ASPECTS 54

5.1 Viewpoint 54

5.2 Selection of economic analysis 54

5.3 Patient population 54

5.4 Comparators 54

5.5 Range of costs and measurement, 54

5.6 Prices 55

5.7 Average use of resources 55

5.8 Measured effects and benefits 56

5.9 Average costs 56

5.10 Incremental cost-effectiveness 57

5.11 Sensitivity analysis 58

5.12 Results from the business case 58


6. DOMAIN 6: ORGANISATIONAL ASPECTS 59

6.1 Method 59

6.2 Process: Work flow 59

6.3 Process: Staff 60



6.4 Process: Communication 60

6.5 Structure 60

6.6 Culture 60


7. DOMAIN 7: SOCIO-CULTURAL, ETHICAL AND LEGAL ASPECTS 61

7.1 Methods 61

7.2 Ethical issues 61

7.3 Legal issues 61

7.4 Socio-cultural issues 62

8. TRANSFERABILITY ASSESSMENT 63

8.1 Assess transferability of clinical effects 63

8.2 Assess transferability of economic effects 63

8.3 Assess transferability of organisational effects 63

APPENDIX A - REFERENCES 64



1. Introduction

1.1 Purpose of this document

This document contains the initial collection of data for the MAST domains for the COPD trials in the United4Health project. It has been prepared to document the data available following completion of recruitment.

1.2 Structure of the document

Section 2 contains information for MAST Domain 1: The health problem and the telemedicine application.

Section 3 contains information on Domains 2 and 3: Safety and clinical effectiveness.

Section 4 contains information and data on Domain 4: Patient perspectives

Section 5 contains information and data on Domain 5: Economic aspects

Section 6 contains information on Domain 6: Organisational aspects

Section 7 contains information on Domain 7: Socio-cultural, ethical and legal aspects

Section 8 discusses transferability assessment

Note that many results from the pilots are not available for this Intermediate Pilot Evaluation, and will be described in the Final Pilot Evaluation. To preserve the structure of this document as a stepping stone towards the Final Pilot Evaluation, the section heading for the results has been included, with the text: “This section will be completed in the Final Trial evaluation”.

1.3 Glossary

COPD Chronic Obstructive Pulmonary Disease

EMR Electronic Medical Record

GP General Practitioner

HCP Healthcare Professional

NICE National Institute of Clinical Excellence (UK)

TM Telemedicine

TMon Telemonitoring

WSD Whole System Demonstrator (UK project)



2. Domain 1: Description of the health problem and characteristics of the application

2.1 The health problem of the patients

Telemonitoring (TMon) for COPD has been associated with reduced emergency admissions and other healthcare contacts[i,ii,iii,iv].

The largest randomised controlled trial (Whole Systems Demonstrator) of telemonitoring for COPD to date has suggested a reduction in mortality by 7-10%, but another large RCT (TeleScot) has shown no convincing clinical benefits; the same also seems to be true of the first available results from RH[v,vi,vii].

What is less clear is:

What should be the target patient population?

Which measurements are most appropriate and useful, e.g. spirometry, pulse oximetry, temperature, symptom management questions and quality of life questions?

The added value of video consultation.

The optimal duration for comprehensive telemonitoring on an ongoing basis.

How telemonitoring could be better utilised to reflect an individual patient’s health status at any given time?

2.2 Burden of the disease

Respiratory disease is the cause of one in seven of all deaths in Wales; the third largest cause of death for both women and men in Wales. At the same time, one in seven adults in Wales reports being treated for a respiratory condition.

Whilst 835,000 people in the UK (70,308 people or 2.01% of the total population in Wales) have been diagnosed with COPD, and with a Welsh smoking prevalence of 23% (Respiratory Health Delivery Plan), it is estimated a further 2 million may be unidentified [2]. COPD kills about 25,000 people per annum in England and Wales, is the fifth biggest killer in the UK, and the only major cause of death on the increase [2, 3]. It is a common cause of hospital admission and a major burden on primary care services. COPD causes progressive breathlessness with coughs and wheezes, punctuated by frailty and a number of co-morbidities1.

2.3 Current management

2.3.1 Scotland

Chronic Obstructive Pulmonary Disease (COPD) is one of the major causes of morbidity and mortality within Scotland and currently accounts for over 10% of all acute hospital admissions, and 30,000 deaths annually in Scotland and the UK.

1 http://www.gpcontract.co.uk/browse/WAL/Chronic%20obstructive%20pulmonary%20disease/14

http://www.gpcontract.co.uk/browse/WAL/Chronic%20obstructive%20pulmonary%20disease/14



Epidemiological evidence suggests that in Scotland there are an estimated 370,000 people with COPD. Only 24%, however, have actually been diagnosed, leaving around 280,000 people unaware that they have a disease. Therefore it is clear that there is currently a great deal of unmet need for people living with this condition.

COPD can be characterised by frequent (and sometimes preventable) exacerbations and admissions to hospital. It is the third most common reason for hospital admission in Scotland, and has high re-admission rates. Many of the localities with the highest COPD admission rates in the UK are in Scotland. It is a major health issue.

Treatment options and management of COPD in NHS Scotland have developed over the past 10 years in line with research, and place greater emphasis on reducing exacerbations, improving quality of life, and improving symptoms and activities of daily living. At the same time, it has become clear that this disease causes a huge burden to individuals and their families.

Across Scotland, in response to meeting increased demand for services, there are a growing number of community based COPD services or early supported discharge services which offer short term follow up for COPD patients in the community across Scotland. The focus of these services is community based; its aims are to stabilise or treat exacerbations, and manage patients where possible in the community before hospital admission. This entails identifying patients with ‘multiple hospital admissions’, otherwise known as ‘revolving-door admissions.

Clinical Guidelines and best practice standards which inform the management of COPD in across primary and secondary care NHS Scotland are:

The 2010 NICE guideline on Management of chronic obstructive pulmonary disease in adults in primary and secondary care (Clinical Guideline 101) is a partial update of the original version published in 2004 (Clinical Guideline 12). www.nice.org.uk/guidance/CG12

COPD service – Clinical Standards and Evaluation - Guidelines 2010, Healthcare Improvement Scotland, HIS.

Diagnostic Support & Period Review of COPD

NHS Scotland standards of care recommend the detection of COPD based on a combination of history taking, physical examination and the confirmation of the presence of chronic airways obstruction using spirometry. Patients are referred to specialists for confirmation of diagnosis. For patients diagnosed with COPD, they are offered a periodic review with GP or respiratory consultant to assess whether the condition has changed, and to intervene if appropriate; it reviews the following:

smoking status;

immunisation status;

assessment of MRC dyspnoea scale;

medication review;

inhaler technique;

education about disease & self management.

Treatment

Once a diagnosis of COPD has been established, effective management is aimed at relieving symptoms, preventing disease progression, and improving exercise tolerance. Other goals of COPD treatment include preventing and treating

http://www.nice.org.uk/guidance/CG12



exacerbations and/or complications, along with improving health status and reducing mortality. The recommended management of stable disease is according to NICE 2010. The management of COPD is both pharmacological and non-pharmacological; it is increasingly clear that focusing on the patient’s activity, nutrition and lifestyle is as important as prescribing bronchodilators. The clinical / treatment stages are in the most part independent of FEV1 and based on patient symptoms. Oxygen therapy, smoking cessation, pharmacological therapies and palliative treatments are additional management approaches. Multiple factors may impact choice and response to treatment, e.g. genetic, phenotype of disease, preference. The most appropriate delivery device should be chosen based on patient preference and other factors, e.g. hand function and fine motor control; proper education in its use is imperative.

The progression of the disease can be slowed down, but not halted, by stopping smoking. All patients with COPD should be encouraged to stop smoking, and offered help with pharmacological interventions (nicotine replacement therapy, bupropion, and varenicline). NHS Scotland has a dedicated helpline managed by NHS 24 which provides 24/7 support and sign posting to smoking cessation programmes nationally across Scotland.

In addition, pulmonary rehabilitation (PR) has been shown to improve health status and levels of activity, and reduce hospital stay. In Scotland, it is typically offered to all patients with COPD who have functional limitation as a result of their condition (usually an MRC dyspnoea score of 3 and above). In addition, pulmonary rehabilitation should be considered in patients recently admitted to hospital with an exacerbation of COPD, as it has been shown to reduce the risk of readmission. Two of the three pilot sites in U4H provide a PR services to patients with COPD. Sessions are multidisciplinary lead with a combination of exercise classes and a focus on disease education, including inhaler technique, smoking cessation and medication usage.

Nationally across Scotland, there are a number of key strategies supporting development of self management resources and peer support groups for COPD which provide practical and realistic support for people living with COPD and their carers. These form an essential part of the care continuum for this group of patients, and dramatically increase patients' ability to self manages their condition and live better, healthier lives.

2.3.2 Wales

Hywel Dda University Health Board (HDUHB) is part of the Wales (UK) NHS and manages people with COPD according to national guidelines (British Thoracic Society, National Institute of Clinical Excellence). In addition, it has contributed to the Welsh Assembly Government’s Respiratory Services Strategy (2014).

Management can be divided into several main strategies:

1. Prevention of COPD

The biggest cause (85%) of COPD is smoking. The only intervention shown to improve all symptoms, slow lung function decline and improve survival in COPD is to quit smoking. In Wales, GPs are encouraged to ask all patients about their smoking habits and expected to offer brief counselling and refer to smoking cessation specialists as part of their routine service (Quality Outcome Framework). The community based service is a free phone number at Stop Smoking Wales;



those wishing to quit are offered free advice and prescriptions. HDUHB is one of three Health Boards offering a secondary care based smoking cessation service with published quit rates, free drop-ins for staff, and a well-established active research portfolio.

2. Detection of COPD

HDUHB offers proactive detection and access to spirometry to diagnose COPD in both primary and secondary care.

3. Treatment of COPD – stable and exacerbation management

Patients with COPD are offered annual flu vaccinations, single dose pneumonia vaccinations, appropriate inhalers, pulmonary rehabilitation, COPD Educational Programme for Patients, non-invasive ventilation, home oxygen and palliation according to the severity of their disease. Hosting several translational and commercial COPD and smoking cessation research trials, the main local hospital (Prince Philip) that is leading U4H for the Health Board has contributed to the BTS national COPD audit in 2014; results are awaited but early reports suggest a good service.

2.3.3 Southern Norway

COPD prevention: Smoking cessation is still the main target to avoid further rise in COPD prevalence. In 2014, 15% of the adult population (16-74 years of age) smoked in Norway, and only 7% of those between 16 and 24 years of age. This is due to a continuous national campaign against smoking, but also to firm local initiatives, so that only 4-5% now smoke in adolescence in the Agder counties.

The diagnosis and treatment of COPD in secondary and primary care in Agder counties is handled according to locally adapted guidelines as published in 2013 and as shown below, on prevention, symptoms, diagnosis, treatment, rehabilitation and follow-up, and for the most referring to the GOLD guidelines.

Forebygging Symptomer Diagnostisering

Pasient/pårørendeinformasjon

Behandling

Oppstartsdokument Kols register

Målinger

Tilleggsdokumentasjon

Målinger og registreringer

Behandlingslinje for kols på Agder

Overordnet flytskjema

Behandlingsansvarlig lege: Frode GallefossKontaktperson:Godkjent dato:

Rehabilitering Oppfølging

Prosedyrer og annen informasjon

Denne behandlingslinjen er laget for personer med kols. Ved å følge behandlingslinjen får pasienter og pårørende den beste behandling, pleie og informasjon bygd på kunnskapsbasert medisin og beste praksis.

Figure 1: Southern Norway COPD guidelines



In addition, the hospital is the first in Norway to produce an e-learning programme on COPD for patients, care givers in primary and secondary care, as shown below (www.sshf.no/kols).

Figure 2: Southern Norway e-learning programme on COPD for patients

2.3.4 Galicia

Prevention of COPD

Smoking is the leading cause of chronic obstructive pulmonary disease (COPD). In Spain, according to data from the National Health Survey 2006, 29.5% of adults over 16 years of age smoke. Men have a higher consumption (35.3%) than women (23.8%). The percentage of smokers varies by age, noting that the lowest proportion of smokers is among those over 65, while young people aged 25-34 are the most likely to smoke. In a more recent National Health Survey (2013), 24% of the population aged 15 or older reported smoking daily, 3.1% were occasional smokers, 19.6% were former smokers and 53.5% had never smoked. By sex, the percentage of smokers was 27.9% among men and 20.2% among women.

It is notable that a large number of COPD patients smoke, even when they are aware of having this condition, and that it adversely affects the course of their disease. In fact, 15% of smokers have COPD.

In Spain, primary care doctors are expected to discourage smoking among their patients, and refer to smoking cessation specialists when needed. Giving up smoking is the only intervention shown to improve respiratory symptoms, reduce lung function decline, and improve survival in COPD.

Detection of COPD

Spanish guidelines (GesEPOC) provide information about COPD diagnosis and treatment, as well as making recommendations for the proper approach to these



patients. Spirometry for COPD diagnosis is available in primary care. The overall incidence of this disease in Spain is 9.1% among people 40-70 years of age. A publication of the EPI-SCAN (2010) study estimated that currently 2,185,764 out of the 21.4 million Spaniards over the age of 40 have COPD. By gender, this represents 1,571,868 men and 628,102 women. Given the fact that 73.1% of patients are undiagnosed, it can be said that more than 1,595,000 Spaniards do not know they suffer from COPD, and therefore receive no treatment. The prevalence of COPD in Galician Region is 8.2%, and 69% of patients are undiagnosed.

In Spain, the disease accounts for 15% of all consultations in primary care, and 40% in respiratory medicine departments. Moreover, COPD is responsible for between 35% and 40% of all permanent occupational disabilities.

For the moment, GesEPOC still recommends the use of the COPD-PS screening questionnaire and spirometry in adults aged over 35, smokers or former smokers with respiratory symptoms (case detection).

Treatment of COPD – stable and exacerbation management:

A range of treatment options exist for COPD Patients, such as flu and pneumonia vaccinations, appropriate inhalers, pulmonary rehabilitation, non-invasive ventilation, home oxygen and palliation when needed.

The diagnosis and treatment of COPD in primary and specialist care is handled according GesEPOC guidelines as published in 2013. The publication of these guidelines has brought about a change in the approach to COPD treatment. According to GesEPOC, the recognition of clinical phenotypes and severity rating scales requires greater involvement of clinicians in the daily care of patients with COPD; but in exchange, they help in customising treatment according to the characteristics of each particular patient. New studies constantly reinforce or challenge the statements made in the guideline. Therefore regular updates on published advances must be placed within the context of guideline principles.

2.3.5 North Norway

COPD is a chronic disease that poses a substantial societal, economic and personal burden. Today, in Norway, 370,000 people are estimated to have COPD, of which 150,000 remain under-diagnosed; there are 20,000 new cases every year. Many patients need repeated hospitalisations due to worsening of disease. Mortality in the patient group is high; 25% of those who entered diagnosed die within two years, and half within five years (Gulsvikfjellet et al 2002 HOD 2006). Studies also show that re-admission rate within 14 days has been 14%, and within one year 46% (Sorknes et al 2011). Data from the University Hospital in North-Norway (UNN) for September 2011 shows a comparable situation: Nearly half of the patient who were admitted with a diagnosis of COPD were re-admitted within a month.

In 2006, a national strategy for COPD was adopted. The aim of the strategy was to improve the prevention, treatment and follow-up of people who are affected, so that they avoid unnecessary morbidity and suffering. Some of the objectives of the strategy, which builds on updated research in this area, are: the treatment to be properly organised, the need for good systematic follow-up of COPD patients in primary and specialist health services, to strive for rational and appropriate interaction between service levels, and to ensure adequate capacity and expertise of COPD among health (MOH 2006). Corresponding to the description from South



Norway above, management of COPD in Norway is provided along national guidelines.

2.3.6 Berlin

5,5% of the population in Berlin (about 178.000 people) are diagnosed with COPD recorded on local Master Plan Berlin at the end of 2012. About 3% of the population in Berlin (102.000 people) are not yet recognised with COPD. In particular, older and dependent patients have a high relevance in this respect.

The provision of COPD services in Berlin is complex. COPD centres of the hospitals are responsible for the care, or it is integrated in the care management of the health care providers by a wide range of professionals, including GPs, consultants, and other primary & secondary healthcare professionals and specialist COPD teams.

In addition, since 2001 there are special disease management programmes (DMP) for COPD, and so-called integrated care contracts with health insurances.

The target of COPD management is a near-norm adjustment regarding the current management of Pflegewerk of the important vital signs, to minimise the risk of long term consequences associated with COPD.

They are suggested in clinical practice guidelines released by various national and international COPD agencies.

The target of COPD treatment includes:

Relieving the symptoms.

Slowing the progress of the disease.

Improving the exercise tolerance.

Preventing and treating complications.

Lifestyle Changes: The most essential step in any treatment plan for COPD is to stop all smoking. It is the only way to keep COPD from getting worse.

Patients with COPD may have trouble to eat enough, because of their symptoms, such as shortness of breath and fatigue.

Medicines: Bronchodilators relax the muscles around the airways. This helps open airways and makes breathing easier. Inhaled glucocorticosteroids help reduce airway inflammation. Oral glucocorticosteroids and antibiotics are given against exacerbations.

Vaccinations: COPD patients need flu shots and pneumococcal vaccination.

Oxygen therapy: If there is not enough oxygen in the blood, the patient may need supplemental oxygen. There are several devices to deliver oxygen to the lungs, including lightweight, portable units. Oxygen can be delivered through a number of devices dependent on the situation: nasal cannula, face mask or via tracheostoma.

Surgery: Surgery is an option for patients with some forms of severe emphysema who are not helped sufficiently by medications alone: Lung volume reduction surgery, lung transplant.



2.4 Use of the technical application

2.4.1 Scotland

For all of the COPD intervention pilot sites (Ayrshire & Arran; Lanarkshire and Greater Glasgow & Clyde), the telehealth solution is integrated into existing service delivery models used locally within each site. Overall, however, the solutions applied aim to:

Increase the clinical resource capacity available within our specialist hospital and community teams to provide COPD services.

Prevent & reduce unplanned, crisis / exacerbation episodes for people with COPD requiring hospital admissions / re admissions.

Introduce monitoring of essential vital signs for patient with COPD.

Improve self management by engaging, educating and empowering patient and their carers in understanding and managing their own COPD.

All patients with COPD who meet the eligibility criteria will be approached by their clinician and introduced to the telehealth concept and technology. Each of the pilot sites has a defined telehealth pathway and an operational policy to support implementation and patient management through the service. Integrating the intervention into existing clinical pathways enables the monitoring to augment and support the current clinical pathways, offering alternative care options and different levels of monitoring intensity to staff, patients and family / carers. The integration of telehealth into existing services is considered a critical success factor for successful deployment at scale which is evident across all three pilot sites.

Specialist nurses visit patients on the ward to give an overview of the project and the requirements for their participation. At this stage, patients are issued with an information pack to read. Once consent is given, patients will receive the telehealth “kit” within 24 hours of being discharged from hospital. If patients meet the criteria, but are discharged before assessed by specialist nurses, these patients are followed up at home.

In Lanarkshire, the professional groups who will largely access the telehealth monitoring will be the specialist respiratory home support service. It is beneficial for the clinicians to share the information provided by the system within their own teams and with community staff working during out-of-hours periods. However, it is anticipated that out-of-hours monitoring can be carried out by GPs and other community staff if required. Lanarkshire is adopting a 24 hour community nursing service which will be able to support this.

Within Ayrshire & Arran, recruitment is from hospital for patients with an exacerbation of COPD; referrals are accepted from ward staff, respiratory specialist nurses, respiratory physiotherapist, community ward clinicians, and also from GPs and District Nurses up to seven days after patients have been discharged from hospital (as per revised protocol).

For Greater Glasgow & Clyde (GGC) pilot, it is medical staff, ward staff, specialist respiratory and respiratory nurses who will identify patients who are appropriate for the intervention. GGC have no community respiratory team services in place, so monitoring remains the responsibility of hospital respiratory staff.



It is envisaged that patients will continue to be visited by healthcare professionals and attend medical appointments. However, some of these visits may not be needed for patient using the telehealth service, as key information (i.e. vital signs, medication reviews) is in the telehealth system and can be accessed directly. Health professionals providing this service can better tailor it to the needs of their patients, knowing that all their telehealth patients have their needs met no matter how simple or complex, using a step up / step down intervention approach. In addition, by taking their own readings, patients can learn what the readings mean and gain a better understanding of their condition .They can also spot any changes to their health, and work out any triggers causing those changes and discuss them with an HCP.

2.4.2 Wales

Potential participants are all sequential hospitalised patients for exacerbation of COPD, and those receiving parental steroids from their GP or Community Chronic Disease Management Nurses. Enrolment is carried out by a team experienced in COPD and telemedicine (TM) or by generic research nurses who are trained in the local study protocol.

Sequential patients attending or admitted with acute exacerbation of COPD through Accident and Emergency (A&E) Departments and any medical wards will be screened, with recruitment ideally just prior to hospital discharge; but this can occur up to seven days post-discharge. Recruitment is limited to resources available, e.g. weekend admissions are likely to be approached on Monday morning.

There is no research nurse or TM member available to recruit on certain days due to their other clinical commitments, and never out-of-hours (evenings and weekends).

Close collaboration with ward and A&E staff is therefore essential. Prior to 24 hours before discharge, each potential participant’s medical notes are screened for inclusion and exclusion criteria by a research or respiratory nurse. The study’s Patient Information Sheet is offered to eligible patients who are also informed about the nature and the objectives of the study orally. Participants are shown the telemonitoring (TMon) equipment, and its use is briefly explained to them. Each patient who agrees to take part in the research study will be supplied with either a Tmon GPRS briefcase (blue box) or landline Tmon device (Docobo®), and trained in the use of the telehealth system either on the ward or within seven days of discharge within their own home. Before deployment, they provide written informed consent, demonstrate that they can complete the symptom questions, and use the peripheral technology, and will return it when requested. The Community Respiratory Nurse will contact the participant via phone within 24 hours of discharge to confirm a signal and arrange a date/time for the first video / teleconference session.


Patients enrolled are hospitalised for a COPD exacerbation and discharged to their home. Enrolment is carried out by two experienced nurses during day time on working days in the hospital wards. Approximately 45-50% of those asked are enrolled. The reasons for non-participation are recorded.

The telemedicine equipment is forwarded by the technical department for medical equipment in the hospital. The patients are followed according to protocol from the telemedicine centre in the community / municipality.



The patient reports are handled at the telemedicine centre by experienced nurses through a colour code system:

Green (improvement or no deterioration) no change of treatment.

Yellow (slight deterioration) treatment increased.

Red (marked deterioration) treatment increased, handling discussed with own GP or specialist.

Discharge

Days 0 14 30 90

Figure 3: Southern Norway: Telemonitoring levels for COPD

2.4.4 Galicia

Potential participants are all sequential patients hospitalised for exacerbation of COPD. Enrolment is carried out by a pulmonologist team experienced in COPD and telemedicine, who are trained in the local study protocol. Sequential patients admitted with acute exacerbation of COPD will be screened, with recruitment just prior to hospital discharge. Recruitment is limited to available resources. Prior to 24 hours before discharge, each potential participant’s medical notes are screened for inclusion and exclusion criteria by a pulmonologist. Eligible patients are duly informed about the nature and the objectives of the study, as well as telemedicine equipment. After providing written informed consent, each patient who enrols in the research study will be supplied with a telemedicine briefcase and trained in the use of the telehealth system. The respiratory nurse will contact the participant via phone within 24 hours of discharge to confirm a signal and arrange a date/time for the first video / teleconference session. Enrolment is carried out by a pulmonologist during day time on working days in the hospital wards. Around 80% of those asked are enrolled. The reasons for non-participation are strictly registered.



TELEMONITORING AT THE COPD PATIENT’S HOME AFTER BEING DISCHARGE

Pulmonologist responsible for

patient´s assistance

Patient admitted for COPD

Discharge report.

-Informed consent. -Written information to patient

Election of participants in the project (new o

readmission)

Enter the study?.

NO

YES

PAX 2

Hospital discharge

Hospital discharge

Pulmonologist coordinator of

the project

Instruction at the Hospital

Unit

Interconsult Admission

Documentation delivery

Possible

discharge

Admission

Fulfillment for the admission of the template in the telemonitoring

platform

YES

PREDISCHARGE Pulmonologist

coordinator (Listed before 12 AM. 24h prior to

discharge)Make the

supplementary report.

READMITTED

NEW

Communication to the management unit and

conduct the supplementary report.

Confirmation of the discharge from pulmonologist

Figure 4: Galicia: Process flow diagram

2.4.5 North Norway

The South Norway pilot is scaled up to North-Norway. The North Norway pilot is based on the technical equipment and software developed in the South Norway pilot.

2.4.6 Berlin

Berlin provides life-long monitoring services for COPD patients. The trial is based on a set of measuring devices connected to a client software application implemented on mobile telephones via Bluetooth, and on a web-based database where the collected data is stored.



The following diagrams show the flowcharts of the information for the technical application in Berlin:

Figure 5: Integration Platform for telemonitoring (COPD)

In particular, the devices and the measurements taken are as follows:

A sphygmomanometer to measure blood pressure and pulse.

A spyrometer to measure Peak Expiratory Flow and other data relevant to the breathing condition of the patient.

A pulse-oxymeter to measure blood oxygen saturation and pulse.

These devices are connected to a mobile device, namely a smart phone, which collects the data and sends them to a centralised database. These data are compared with multi-valued threshold levels; statistics are collected and stored in electronic Patient Health Records. There a doctor, a family member, the patient or any other person explicitly authorised for this by the patient himself can look at the situation, and notice any values that may give rise to doubt in a timely fashion and act accordingly.

Berlin COPD



Figure 6: The architecture of the technical application in Berlin.

Figure 7: The architecture of the nurse-assisted implementation of the technical application in Berlin

The patient's health records and some graphical representation of the measured data are shown in the following pictures:



Figure 8: The web-based electronic health records of the Berlin system

Figure 9: An example of the display of measured values for weight

Figure 10: An example of the values curve for pulse and oxygen saturation

Measurements are taken directly by the patient himself, where possible. Where appropriate, however, the assistance / coaching of a nurse is provided. If necessary, alarms are sent to family members, caregivers and/or doctors. Otherwise, the



assisting nurse can immediately provide the necessary care. A telephone contact with the patient is made more frequently than before.

If needed, doctors, specialists and nurses can receive a periodic report on the situation of the patient via email or fax. This report would look like this:

Figure 11: An example of report care givers can receive on demand

The ways in which this intervention is expected to improve the condition of patients are many:

On the one hand, the smart phone includes a reminder function which helps to make sure that the patient does not skip a measurement. This has been a common problem in the past, both with measurements and with drugs. This improvement in compliance is expected to have a benefit for the life and health of patients.

On the other hand, the automatic sending of alarms guarantees that these are sent quicker than before, and that appropriate measures are also taken faster.



Another improvement is in the psychological situation of the patient, who feels in touch with the world a lot more often than before, and feels that he/she is being taken good care of.

2.5 Technical characteristics

A patient admitted with a COPD exacerbation is discharged from hospital and provided with a telemonitoring package including video conferencing, together with a pulse oximeter (Figure 12). Each day the patient will answer their symptom management questions, record their pulse oximetry reading, and upload this data according to their agreed management plan before accessing a video consultation.

Figure 12: COPD telemonitoring system architecture

The intervention (provided service) represents three levels of intensity of telemonitoring with specific duration for each level (Figure 13):

1. High Level TMon: Daily teleconsultation (preferably via video-consultation, or telephone if not possible); pulse oximetry and daily symptom questions are uploaded prior to the teleconsultation, and will provide a partially standardised structure to the interview. This level of TMon is targeted for 10 working days (but can be a minimum of 5, maximum of 30 days) after discharge to allow some pragmatism and better reflect a potential real-life clinical service.

2. Moderate Level TMon: Daily pulse oximetry and symptom questions uploaded for up to 12 weeks (minimum of 4 weeks) after discharge.

3. Low Level TMon: Optional symptom management questions and text message behaviour prompts or website links sent to a mobile phone for up to 12 months after discharge.

During the High level of TMon, a clinician (likely to be a specialist respiratory nurse) makes a scheduled teleconsultation (preferably video-consultation, otherwise telephone contact) with the patient after the receipt and review of the uploaded data (pulse and SpO2 and symptom questions) from the patient that day.



During the first 10 days, the clinician will determine a step down transition from the High Level to Moderate Level, or continued High Level if needed. Those needing High Level TMon after 30 days, or anyone with worrying clinical features or a combination of alerts (see below), will be referred for physician assessment. This should be to primary care or the hospital depending on clinical discretion. If readmitted to hospital, they remain within the study and are discharged again with High Level TMon.

After 10 working days, all patients deemed clinically stable will be reviewed by the specialist nurse with the specific intention to reduce the intensity of TMon to Moderate Level of TMon for up to a maximum of 12 week, with clinical discretion to step down earlier (minimum 4 weeks) or back to Higher Level.

Figure 13: Three levels of intervention intensity (step-down COPD monitoring service)

Data recorded during High and Moderate TMon includes: pulse, oxygen saturation and answers to six pre-selected questions on symptoms:

1. How do you feel today? Better, Usual, Worse.

2. How is your breathing? Usual, worse, much worse.

3. How is the amount of your sputum? Usual, worse, much worse.

4. How is your sputum colour? Clear/white, yellow, dark green or brown.

5. Are you using your reliever Inhalers/ nebs or oxygen? Same as usual, more than usual, much more than usual.

6. Are you taking any EXTRA antibiotics or steroids at the moment? Yes, No

An alert email/text will be sent to the respiratory nurse specialist if:

Pulse rate <50 or >120 bpm.

Oxygen saturations fall by 6% or more from their discharge baseline.

Two from six questions are out of range (‘worse’ or ‘more than usual’) for two consecutive days.



The respiratory nurse will contact the patient for video / telephone review, or a home visit, or advise to attend hospital, according to their discretion. Criteria for hospital treatment will follow local protocols. Thereafter they will continue on Low level TMon (text prompts etc.) optionally for up to 12 months after last discharge.

Below is a description of the technical solutions in each region:

2.5.1 Scotland

Within NHS Scotland, the use of technology to monitor the patient’s condition at home is integrated into the existing care pathways for patients with COPD. There are different solutions, each of which is compliant with the technology requirements of the project, and can be used to deliver all three levels of intervention intensity (step-down COPD monitoring service).

Pilot site 1 – NHS Lanarkshire

The software solution installed in NHS Lanarkshire is Simple Telehealth, also known as Florence, which is a national product developed by NHS England. www.getflorence.co.uk.

Essentially this is text message service which sends information, collects data and links directly to clinician’s computer software. The software displays the data, and creates graphs and tables, so that clinicians can easily see the vital statistics on their patients’ health. Using collected data, the system can also automatically advise a patient and/or clinician if pre agreed action needs to be taken.

This system can support SMS texts from patient's own mobile device without the need for software download. Patient or carer supplies blood oximtery and temperature reading, and replies to symptoms questions via SMS through a standard 3G connection. Clinical parameters can be set for each individual patient by the specialist nurse, with alerts sent to the clinician’s mobile device, i.e. phone or tablet, and shared with the wider clinical team as required. These alerts or “critical breaches” are based on a COPD clinical algorithm and decision tree developed by clinical staff, and provide an alert to staff that a patient needs to be reviewed.

The Florence system is shown below; it requires minimal set up once the initial software has been installed on the main receiving unit The clinician can view the results uploaded to FLO alongside graphs, trends, alerts and messages on a secure internet connection, at any time. Additional benefits include the ability to send automated and specific texts to the patient to give instruction, reassurance or reminder of appointment time, or additional health coaching messages.

http://www.getflorence.co.uk/



Figure 14: Florence software solution

Pilot Site 2 - Ayrshire and Arran

The solution being used by Ayrshire & Arran is Medvivo’s Home Pod (www.medvivo.co.uk).

The Home Pod itself, which consists of tablet hardware with either Windows or Android, is the central hub, communicating via broadband or 2G/3G/4G to the clinical triaging system, and by Bluetooth or USB to the patient medical devices. The Home Pod module which interacts with the patient is the PUI, or patient user interface. It supports the patient protocols and interacts with the medical devices.

Figure 15: Home Pod schematic: Integrated service solution - COPD



The clinical user interface (CUI) is the patient management software that resides on a clinician’s PC or tablet, or on a terminal in the triage / call centre within the pilot site. The CUI is the management console that interacts with the patient and Home Pod in allowing the patient record to be set up, protocols to be configured, and readings to be monitored, and triaging management. There are two versions of the CUI; Windows, which has extensive functionality and configurability, and a web version which is lighter and manages all the day-to-day activities of a clinician and a triaging Centre.

The Home Pod is used to collect patient vital signs data from the patients’ home, and then feed that data to a central server, sitting behind the N3 firewall stored (encrypted) on the Home Pod. After successful transmission, the data registers are emptied.

Typical connection between the Home Pod and the server is securely over GPRS. In areas of poor / no signal, POTS (dial up modems) are used. Connection via home-based ADSL / Internet is readily available, but generally it is policy not to use public networks for security / data compliance reasons.

Data downloads to the Home Pod fall into two scenarios. Firstly, remote system updates or patient protocol changes, and secondly, a patient's request to retrieve their results. The first scenario can either be automatically initiated by the Home Pod once the patient has entered their pin, or on a polling basis. The second scenario is on a demand basis each time the patient requests some history. The update process is very scalable and sensitive to bandwidth / load balancing constraints.

Pilot Site 3 – Greater Glasgow & Clyde

This pilot site is deploying a software platform called Safe Mobile Care (SMC) (www.safepatientsystems.com).

SMC is an “end to end” mhealth web based care solution that uses clinically validated questionnaire sets, appropriate vital sign data capture, and medication reminders through the use of a specially configured Smartphone or tablet device (patient's choice). It is used alongside the technology and a number of peripherals (wireless) to allow easy capture of vitals signs, in particular, the use of pulse oximetry & temperature.

Outlined below is an overview of the set up of Safe Mobile Care and its technical characteristics.

http://www.safepatientsystems.com/



Figure 16: Safe Mobile Care overview

The HCP selects a suitable clinical questionnaire or develops their own content, sets vital sign parameters, and creates an individual care plan on the web based triage management software. This included scheduling and alert protocols which generate a unique personalised PIN code. Once uploaded on the device, the personal care plan will prompt patient to supply data and answer symptom based questions. Immediate feedback is sent to the patient based in their input, as well as an alert sent to the appropriate monitoring HCP, or community team within GGC.

The monitoring clinician will access the patient’s information through the web platform, where they can review the cause of the alert and any relevant patient monitoring history. The system also allows the clinician to agree actions or inform a health goal, which can then be linked and tracked directly to patient outcomes.

This solution has the built in functionality to offer video consultation, which will be introduced as part of the pilot once the infrastructure within NHS Scotland is able to support it.

2.5.2 Wales

The overarching architecture is illustrated in the figure below.



Figure 17: System architecture in Wales

The Hywel Dda University Health Board software solution installed is primarily the Florence software system. Florence (often referred to as Flo) is an NHS hosted non-commercial product supported by Simple Telerate (Stoke-on-Trent, NHS England, www.getflorence.co.uk).

A patient or their carer performs the blood oximetry, temperature and symptom questions daily. The oximetry and temperature recordings are sent to the computer tablet via Bluetooth, and transferred to a computerised decision tree in Flo. The symptom questions are responded to manually by the patient, and answers are typed, either by the patient or their carer, into the computer tablet where this is also uploaded to Flo.

Flo analyses the data according to an individualised set of parameters, and provides instant feedback to the patient via their computer tablet along with locally agreed advice messages as required. Should the readings submitted be outside of the individually agreed parameters, an alert will be sent to the patient in the first instance. A message will be sent back to the patient via Flo advising them to act according to a self management plan agreed by the patient and the practitioner. An alert message will be sent to the primary healthcare provider; this will be classified as a ‘critical breach’ according to parameters set around the alert, advising them to review the patient, e.g. if the patient’s readings have been outside set parameters on four occasions over a 48 hour period. This can be reviewed immediately (or the next working day if the anomalous parameter occurs outside of normal working hours).

During the study, the patient will also receive standardised health coaching messages every three days. Patients will be reminded upon entering the study, and through the Patient Information Sheet, that if patients require the attention of a

http://www.getflorence.co.uk/



healthcare professional (in relation to their COPD), or they have received a text message via Flo to seek advice, it is the patients’ responsibility to make contact.

Healthcare professionals (primarily the primary care staff who routinely deal with the patients) will be able to access the results uploaded to Flo, via a secure internet connection, at any time.

Wales has also had to put in an alternative solution if access to Flo is not available. The alternative, which can be accessed through a home telephone line, allows for a range of options to patients and staff.


According to the general United4Health project requirements, the South Norway setup includes the use of a pulse oximeter and a daily questionnaire, with a Step-down intervention as shown in Figure 13. The technical solutions are implemented according to legal requirements in Norway for shared access to medical information, and according to security requirements, the backend servers are installed within the secured National Health Network as shown in Figure 18 below.

Figure 18: Overview of Southern Norway solution

Sørlandet Hospital is responsible for the ICT solution. At discharge from hospital, they will provide the patient with a dedicated suitcase containing a tablet PC and a pulse-oximeter. Nurses at Pulmonary Department will give the patient the necessary training in the use of the equipment. We have found that if the nurses follow up the patient within some days after discharge, the number of patients giving their consent to participate increases compared to the situation at discharge.

The patient’s tablet is configured with Windows 8.1 Pro, where a dedicated eHealth App is installed. The eHealth App and the receiving data system “Information Integration Portal” have been developed for the United4Health project by University of Agder as a secure solution. The App contains the daily questionnaire and Bluetooth communication with a Nonin pulseoxymeter, in addition to a secured VPN connection to the backend servers. The App also includes a CAT questionnaire and COPD training software as described in section 2.3.3.



In addition, a secure end-to-end encrypted video conference solution is implemented on the tablet PC. According to established services within the National Health Network, we have used the Cisco Jabber Video clients, which are supported from the back-end services.

In order to guarantee the necessary data security, the implemented ICT solutions has been thoroughly evaluated according to defined requirements for risk and security analysis.

Within the South Norway Region, there are 30 municipalities organised into five healthcare districts. According to the Norwegian Coordination reform from 2012, the municipality healthcare services will be responsible for patient follow-up after hospital discharge. Based in this regulation, we have established two telemedicine centres for the daily follow-up of patients, one located at Valhalla nursing home in municipality of Kristiansand, and one in municipality of Farsund; both centres are responsible for patients originally resident in the surrounding municipalities.

In close collaboration with University of Agder, the company Devoteam developed the software used at the Telemedicine Centre. This solution is described as a “Treatment Pathway Health Record”, and provides shared access to stored medical data according to legal regulations in Norway from 1st January 2015. A user-centric design process was followed during software development, including usability evaluations at the eHealth lab at University of Agder. Scientific publications describing this development process have been submitted to international conferences.

2.5.4 Galicia

The architecture is illustrated in the figure below:

Figure 19: Galicia architecture



The platform consists of a central Digital Home care system that provides the added value modules for supporting clinical protocols and all patient communication functions.

The system has been designed to seamlessly integrate all information flows with the patient into the EHR and clinical applications for the professionals.

The main functions that the Digital Home system provides are:

Protocol and guidelines definitions available to the professional from EHR system. The system gives support to the defined processes for the follow up of chronic patients.

All parameters are received from the patient’s home, acquired with medical devices integrated through Continua and IHE standards to guarantee that third parties devices and applications can be integrated at different layers.

The system is completed by providing several functionalities that are available not only for COPD patients, but for any other chronic pathologies that could be followed in the future: - Alarm threshold and messaging from patient to professionals. - Telecare management programme. - Analysis and parameters register. - Control medication administration and adherence. - Deployment of multimedia contents. - Telecare (asynchronous) control. - Tele-consultation (synchronous). - Questionnaires for patients are also supported and made available to

patient via computer tablet. (EQ5D questionnaire is used for COPD). - Contents in multimedia format are also available to patient for instructing

and provide information on how to use devices.

Integration of service will be as shown in the following figure.



Figure 20: Galicia service integration



2.5.5 North Norway

The organisation of the North Norway telemedicine solution corresponds to South Norway, see Figure 18 above. In North Norway, the University Hospital provides the service and the telemedicine centre is located there. This represents a variation to the service given in South Norway, where the municipality provides the follow up.

2.5.6 Berlin

The technology of the telemedicine application in Berlin mainly uses three sorts of devices:

Measuring devices equipped with Bluetooth interface to send the data to a suitable receiving device. Such equipment has been on the market for a time, but is not yet widely used. The Bluetooth interface increases, as is obvious, the cost of the equipment, and makes it suitable only for a telemedicine application. However it is expected that these applications will increase in number in the near future, and this will make the devices more affordable.

Smart phones as a receiver of the measurement data. These are becoming more and more available, and therefore also affordable, and the quality is improving very rapidly. This is important to ensure that the measurements are right, and get to the right place at the right time.

A web-based database to store the data and an application to manipulate them, and to make some calculations and presentation (e.g. in the form of charts). This is also a technology that is not new, but it is being improved dramatically on a daily basis; one of the challenges of the application is keeping up with these technological improvements.

At the moment, the application used in Berlin is a fairly stand-alone and proprietary application, but steps are being made to ensure this does not remain so. Integration with the electronic patient records of Pflegewerk is under discussion with the providers of the two software solutions. Other software solutions are being investigated, that will allow integration of the application both with the patient management software of Pflegewerk, and with the future German central patient health records.

2.6 Requirements

2.6.1 Scotland

2.6.1.1 Pilot Site – Lanarkshire

Equipment:

Pulse oximeter.

Thermometers are provided by the practitioner.

Patient is able to use equipment which is already in place.

Patient uses own mobile phone device.

No mobile devices are supplied by NHS Lanarkshire for the pilot.

Software is Florence, as described in section 2.5.1.



To assist in the monitoring of patients, specialist nurses are being provided with Smartphones to access patient information and allow immediate registration of the patient to the system. A tablet device (Samsung Galaxy) is also being provided in each of the acute hospitals to improve technical communication between clinics and wards.

Training for patients and HCPs

For the Florence system, a patient information booklet is covered by the practitioner at the recruitment stage. This is a comprehensive booklet which covers the following:

What is telehealth?

Will I still see a respiratory nurse?

How do I give consent?

How does the telehealth system work?

My telehealth equipment.

Recording your oxygen and pulse rate.

When should I record my oxygen level and pulse rate?

How do I record my oxygen and pulse rate?

Replacing the batteries in the pulse oximeter.

Sending your measurements via text.

Patients with any additional learning needs are offered suitable support from staff from third sector organisations, i.e. Age Scotland, who will work alongside clinical staff to introduce technology and management plan.

Staff / clinician user guide was provided to each member of staff with an on-line help advice service available. This guide is made available to all staff. Staff training has been carried out with onsite sessions and video-conferencing with Florence team, lasting approximately six hours depending on requirements.

Continued telephone support has been available to facilitate the setting up and testing of the specific protocols for each service, and one-to-one cascading of information carried out within Lanarkshire by respiratory physiotherapist team leader and project manager to support the implementation.

There is also a telephone help line for any technical queries, and additional implementation support has been purchased from the supplier. Additionally, part of the licence costs cover access to the Simple Telehealth online “community of practice" which is an online network that enables peer support from all current groups using Florence.

2.6.1.2 NHS Greater Glasgow and Clyde

Equipment

Tablet device supplied by Safe Patient Systems.

Wireless peripheral devices: pulse oximeter & thermometer.

Installation and reinstallation of equipment is completed by Safe Patient systems. On delivery of the equipment, patients are supplied with an information booklet about the technology, contact details, information about



the project, and a helpdesk number which can be used to register and report faults.


Patients

Patients who are recruited receive a demonstration of the tablet device and use of peripherals from a specialist nurse who is competent in the use of the device and system. 24 hours after the patient is discharged from hospital, a specialist respiratory nurse visits the patient at home to provide a full training session, and go through in detail each stage of the device.

When the nurse is satisfied that the patient is confident using the device and peripherals, the account is then activated. Any additional training which is identified as being required is provided by the specialist nurse.

An information booklet for patients has been developed providing guidance to use of the technology, emergency contacts, and how to use peripherals.

HCPs

Staff also received training on the device and peripherals from Safe Patient Systems (SPS); initially, training was provided to clinical staff then specialist nurses.

A named individual from SPS is available to specialist nurses to answer any technical queries.

2.6.1.3 NHS Ayrshire and Arran

Equipment

The patient hardware required for pilot is

Medvivo Home POD

Pulse Oximeter

Thermometer

Software is Home pod schematic Integrated service Solution -


Patients

Patients are introduced to the equipment by their clinician who explains the aims and objectives of using it. The patient is then given the opportunity to take various measurements / tests, such as blood oxygen saturation monitor or blood pressure cuff, using the PODs and other equipment / peripherals.

Following agreement from the patient to use the equipment, Microtech visits the patient at home to install the equipment while providing 1-1 training. A patient information leaflet is also left with the patient with contact details in case these are required.

A patient leaflet has also been produced to give a basic overview of home monitoring and types of equipment.



HCPs

A rolling programme of awareness sessions and further in-depth training has been delivered to staff and HCPs who need to use the Home Pods. Microtech carry out training for staff on the CUI as and when required.

This training takes about an hour, including the time to download the CUI onto the required PCs. The Microtech technician will demonstrate the CUI showing test patient information, and go through the protocols for adding patient details, adding protocols, setting individual parameters, etc. Once the clinicians being trained are happy, they will use the CUI themselves and check mock results. When staff are confident in using the equipment, they will sign a form confirming this, and be given the CUI User Manual. Further support is always available from the Microtech support / helpline.

2.6.2 Wales

Equipment

The patient hardware required for the Hywel Dda University Health Board trial is:

Pulse oximeter.

Thermometer.

Computer tablet or home telemonitoring box or mobile phone, depending on what is most appropriate for the patient, but also depending on the availability of a GPRS signal for use of the computer tablet.

Carry box.

The hardware used by patients recruited to the study will be provided by Hywel Dda University Health Board at secondary care level.

The software is the Flo system as described in section 2.5.2

Training patients and HCPs

Patients

Patients within the Welsh trial arm will primarily be those who are currently in hospital with an exacerbation of their COPD. The aim will be to recruit a total of 200 patients to be trained.

Training is to be interactive, meaning that it will not have a strict flow, but may be flexible depending on the questions that arise.

Each training session will start with a general introduction on eHealth applications and an explanation of the purpose of the study. Subsequently, the use of the COPD Briefcase equipment and the way it communicates with the other specialised devices will be explained. After that, live demos will make clear the practical use of the equipment. Finally, any questions will be answered, any confusing parts of the training clarified, and ways to overcome frequent problems and mistakes will be presented.

Training will be given, on an individual basis, and will be provided by staff within each implementation area. The trainer will discuss and demonstrate interaction with the Florence software system. This is the system that patients use to upload data



via a computer tablet, and which feeds back messages and lifestyle coaching messages that are relayed back to the patient.

Patients will be advised that they will not be communicating directly with a healthcare provider. They will be informed that this service is purely a computer messaging service to an electronic decision tree system. They will be advised by the messaging system (Florence software system).

Study participants will have a demonstration followed by an assessment to ensure they are competent to use the devices provided, and are able to respond to the Florence software system.

The general thematic units of the training can be summarised as the proper use of the messaging software system, the performance of medical measurements, i.e. blood oxygen and temperature, and transmission of data through the computer tablet device. The training material covers:

Functionality of the Florence telehealth system.

Receiving and displaying messages.

Navigation.

Key functions.

During the training, the patients will be given the following:

Patient information leaflet (study and Simple Telehealth).

Consent form.

User leaflets for the devices to be used (pulse oximeter, thermometer and computer tablet).

The patients in this arm of the study will only be given material relating to their COPD, with no interference from the other clusters as per usual care.

HCPs

The professionals to be trained will be community COPD nurses and secondary care staff, including doctors, qualified nurses, healthcare assistants and ward clerks. The training will take approximately 1 - 2 hours; this will be conducted in each implementation area, and may vary in content and duration, due to the different levels of detail that may be required per staff member. It will be interactive, in the sense that whenever a question emerges, it will be explained and facilitated with simple examples, skipping if necessary the normal flow of the course.

Training is specific to the application of either the Florence software system or the home telemonitoring box (as appropriate), the devices, and the administration forms.

Each session starts with a general discussion to provide information about the study, with an introduction on eHealth applications. Functionality of the corresponding devices of the COPD cluster will be explained. Subsequently, the use of the software for displaying the messaging facilities will be explained, together with the way it communicates with the other specialised devices. After that, live demos will make clear the practical use of the equipment. Finally, any questions will be answered, any confusing parts of the training clarified, and ways to overcome frequent problems and mistakes will be presented.

Training materials are provided both in paper and electronic form, along with relevant patient documentation to be completed during recruitment of patients.



Healthcare providers are trained in the use of the electronic software system (Simple Telehealth) computer application and the management of the online electronic medical folder (software for displaying patient data and messages).

Specifically, they are trained in the following applications:

Introduction to purpose and requirements of the study, i.e. Inclusion criteria and recruitment of patients.

Introduction to eHealth applications (Florence software system/home telemonitoring device).

Log in.

Add a patient.

General details. - View readings; - Patient Services; - Add a patient service; - Editing patient services; - Personalising protocols; - Alerts & messages; - View my patients; - Transferring patients to colleagues; - Personalising/Editing your own profile; - Sending alerts to a group mail box; - Receiving personal notification of alerts; - Notifying a named colleague of your alerts; - Discharging a patient; - Instructing patients; - Information on how to use devices provided by study as appropriate; - Trouble shooting; - Transmission of data and storing at the central server through the computer

tablet device; - Information re: COPD health coaching messages; - Information re: EQ5D questionnaire.

During the training, healthcare providers will be given the following training and patient material which includes but not limited to:

COPD training package.

Check list for training package.

Florence – clinician step by step guide.

Consent form (Welsh & English).

Self management form (Welsh & English).

Patient information leaflet (Welsh & English).

Record sheet – non consenting participants.

Copy of COPD Health Messages.

Copy of EQ5D questionnaire via computer tablet.




Equipment

Necessary equipment for the patient’s COPD suitcase has been purchased by Sørlandet Hospital according to existing contracts for medical equipment and general ICT equipment. Thus, no external tender was necessary.

As an additional R&D project funded by the Research Council of Norway, Devoteam and University of Agder have been responsible for all software developments, and Sørlandet Hospital has by contract a general licence to this software to be used within the Agder region for future services.

In order to obtain a robust and reliable telemedicine solution for the future health care services, requirements for broad scale deployment have been the major fundamentals for the implementation. As one of the first telemedicine solutions, we have implemented back-end servers within the secured National Health Network according to their specific requirements. A dedicated VPN connection between the patient’s tablet PC and the back-end servers has been implemented, giving a secured transfer of the patient’s self-reported data. Data transfer is based on standard mobile data, which has a relatively satisfactory coverage within the region, with data speed according to a 3G/4G mobile data protocol. Based on privacy requirements, a defined patient-ID is used in all system configurations.

Dedicated security software has been implemented on the patient’s tablet PC, in order to restrict the user only to the dedicated eHealth App, and without any normal Internet access, as this might be a security risk for equipment connected directly to the secured National Health Network.

Training

Patients are trained in the use of the equipment at discharge from hospital. In addition, an easy to understand written user guide is available in the COPD suitcase. A dedicated video within the eHealth App gives the user information on how to operate the tablet PC with the questionnaires. In addition, instructions will show how to use the Bluetooth pulseoxymeter where recorded values for SPO2 and pulse are given on the screen before the patient presses a software button to upload the recorded values to be available at the Telemedicine Centre.

A qualitative study / evaluation of the patient’s experience shows that the system is easy to operate; patients give comments on the importance for them to be able to have a daily video meeting with nurses at the Telemedicine Centre.

Nurses operating the Telemedicine Centres have undergone a dedicated training programme containing both detailed clinical education in COPD and necessary technical training in how to operate the equipment installed. They are also trained in how to assist patients of they encounter any technical problems or have difficulties in how to operate the tablet PC and the pulseoxymeter.

Nurses at the home nurse services in the municipalities have also been given information about this new telemedicine service, and especially on how they can assist patients if any technical problems occur.



2.6.4 Galicia

Equipment

Pulse oximeter.

Tablet computer.

Briefcase.

The hardware used in the study will be provided to recruited patients by Movistar.

The software system is described in section 2.5.4

Training for patients

Training is to be interactive and flexible depending on the questions that arise.

The training session will start with a general introduction on eHealth applications and an explanation of the purpose of the study. Subsequently, the use of the Briefcase equipment and the way it communicates with the other specialised devices will be explained, and live demonstrations will help to clarify the practical use of the equipment. All questions and confusions will be dealt with, and frequently encountered problems will be presented.

Training will be given, on an individual basis, and will be provided by staff within each implementation area. The trainer will discuss and demonstrate interaction with the software system. This is the system that patients use to upload data via a computer tablet, and which feeds back messages and lifestyle coaching messages to the patient.

Study participants will be assessed to ensure they are competent in the use of the devices and software provided.

The general thematic units of the training can be summarised as follows:

Proper use of the messaging software system.

Performance of medical measurements, i.e. Blood oxygen and heart rate.

Transmission of data through the tablet computer device.

Healthcare professionals

The healthcare professionals involved in this study have also received specialised training at each of the participating hospitals. The training took approximately four hours, and included content adapted to the different levels required by staff. It was carried out interactively, such that whenever a question arose, it was explained and practical examples were provided.

The training was specific to the application of either the software system or the home telemonitoring box (as appropriate), the devices, and the administration forms.

Each session started with a general discussion to provide information about the study, with an introduction on eHealth applications. Functionality of the corresponding devices was explained, followed by messaging software and an explanation of communications with the other specialised devices. Practical demonstrations helped clarify how to use the equipment. All questions and confusions were dealt, with and frequently encountered problems were presented.



Training materials were provided both in paper and electronic form, along with relevant patient documentation to be completed during recruitment of patients.

Nurses involved in the study underwent a dedicated training programme containing both detailed clinical education in COPD and the necessary technical training in how to operate the equipment installed. They were also trained in how to assist patients if any technical problems were encountered.

2.6.5 North Norway

North Norway is the same as South Norway, see section 2.6.3.

2.6.6 Berlin

Equipment

For the application in Berlin, the following equipment and supplies are needed:

Weight scale.

Spyrometer.

Pulse-oxymeter.

Smart phone with the Android operating system.

All these devices must be capable of transmitting data via Bluetooth, and the smart phone must have an active internet connection (either via WiFi, or via UMTS or similar). In addition to that, they must be equipped with appropriate software to ensure the safe transmission of the data.

At the other end, a computer with internet connection is needed to be able to access the database and display the data. The people who are supposed to receive alarms must have an e-mail address, a fax machine or a mobile phone to receive texts (SMS).

Training

The training needed for users is mainly on the application for the smart phone. It is assumed, and it is indeed normally so, that both patients and staff are able to use the measuring devices because they do not differ from the kind they are used to in their normal life. The only really new part is this application, which is however very simple and can be learned very quickly. Although the application runs on any Android-based smart phone, it is advisable that one be chosen with a fairly large display in order to be able to read the names and the messages on the screen. This is especially true for older people with difficulties in seeing or understanding small text.

We estimate the time needed for a nurse to learn the application is two hours, and for a patient one week.



3. Domain 2 and 3: Safety and clinical effectiveness

3.1 Methods: Trial design

Renewing Health has demonstrated the efficacy of the interventions in randomised controlled trials. Thus the clinical impact has been demonstrated in studies with a high degree of internal validity and in experimental conditions.

However, real life effectiveness of these interventions has not been demonstrated yet. As described in Hendy et al. (2012)[8] in a study of the implementation of the WSD, the randomised design may result in a number of practical problems for the organisations who carry out the study and perform the data collection. For example, the knowledge and experiences gained during the trial cannot be used to improve the intervention during the study, because the service must remain constant during the latter.

Therefore United4Health will study the effectiveness of the interventions in an observational design by comparing a control group treated before the implementation of the telemedicine interventions with an intervention group treated after the implementation of telemedicine. The strengths of this study design are complementary to the evidence of efficacy demonstrated in several efficacy trials[9], and are based on:

1. Long follow-up period which allows for registering and monitoring long-term clinical effects and safety data[10].

2. Big sample size representative of the general population, which allows for stratification analysis and identification of patient subgroups that benefit the most from the intervention[11].

3. Real-life data about impact on costs and organisation (structure and processes) which allows the identification of barriers and facilitators for a wider service implementation[12].

In addition, from an ethical perspective, the service that is proved to be efficacious should be offered to all potential healthcare users. This type of study design will assess the real-life effectiveness of the trialled services with a high degree of external validity and generalisability of the results. Due to inclusion of patients from many European countries, this study will be able to provide to other regions in Europe a very valid estimate of the expected impact of the interventions.

The observational study is using as a comparator group the total population of the patients fulfilling the eligibility criteria who have been treated and followed for at least one year before the implementation of the telemedicine service, and in the same health units as the intervention group, and whose data are available through EMR or other databases (retrospective collection of data regarding demographics, clinical and economic outcomes for the comparator group). Additional data regarding the costs of the telemedicine service, patient perception and organisational aspects will be collected for the intervention group.



3.2 Methods: Participants

Inclusion criteria: Hospitalisation for exacerbation of COPD according to the Global Strategy for Diagnosis (GOLD), Management, and Prevention of COPD[13]. We aim to recruit sequential patients until each site’s target is reached.

The exclusion criteria will include any reason for non-participation, including:

Those unwilling or unable to provide written consent. (The study team will ask for a reason, but will emphasise that the potential subject is under no obligation to provide one.)

Discharged to a locality not covered by the outreach TMon team / hospital (e.g. different geographical area served by another hospital / health institution, or discharged to a new setting, i.e. from home prior to admission and discharged to a nursing home).

Discharged to a locality with no mobile phone signal.

Those unable or unwilling to use TMon after teaching, but prior to installation.

Clinician’s discretion: free text stating the clinical reason will be allowed here (prompts to guide the text include: unreliable behaviour, chaotic social circumstances, including drug or alcohol abuse etc.).

The number of patients who were screened but not included in the study, and the underlying reasons, will be registered and analysed with a common questionnaire among the three pilots, with a view to identifying patient subgroup populations who are currently excluded from the provided services[14]. Such classification of reasons for non-participation would help to identify existing barriers to provision of telemonitoring services to patients with chronic conditions, and to work further to overcome the reasons which are not patient-related, such as logistic / technical limitations and clinician’s assessment decision.

Potential participants are all patients hospitalised for exacerbation of COPD.

Enrolment will be carried out by a team experienced in COPD and TMon for each study site. Sequential patients admitted with AECOPD through EMRs (at least overnight) and any medical wards will be screened daily, aiming for consecutive recruitment just prior to hospital discharge, according to resources available (e.g. weekend admissions are likely to be approached Monday morning). Close collaboration with ward and EMR staff is therefore essential. Candidates are informed about the nature and the objectives of the intervention, and the TMon equipment will be shown. Each patient will be supplied with a TMon briefcase and trained in the use of the telehealth system either on the ward, or within 24 hours of discharge once in their own home. Before deployment, they will demonstrate that they can complete symptom questions and use the technology; ideally a signal is tested.

Local deviations from the criteria described above are presented in the following sections:

3.2.1 Scotland

No deviations from the overarching eligibility criteria.



3.2.2 Wales

In Wales there are no deviations from the overarching eligibility criteria.


In South Norway there are no deviations from the overarching eligibility criteria.

3.2.4 Galicia

In Galicia there are no deviations from the overarching eligibility criteria.

3.2.5 North Norway

In North Norway there are no deviations from the overarching eligibility criteria.

3.2.6 Berlin

In Berlin there are no deviations from the overarching eligibility criteria.

3.3 Methods: Interventions

Refer to domain 1.

3.4 Methods: Outcomes

Primary outcome:

Number of (re)admissions for COPD exacerbations within one month between the Intervention and Comparator Groups.

Secondary outcomes:

a) Admission data - Number of readmissions for COPD at 3, 6 and 12 months. - Number of days in hospital for COPD over 12 months. - Mean length of stay for re-admission for COPD. - Mean/median time to first COPD readmission.

b) Health contacts - Number ED visits. - Number of visits to GPs and primary healthcare. - Number of specialist nurse home visits. - Number of clinic visits to secondary care. - Mortality rate at 12 months.

Other Outcomes:

CAT score development at 3, 6 and 12 months’ follow-up (optional).

Demographics:

Year of birth.



Gender.

Smoking status: never, ex, current.

Social: lives alone Y/N; carers informal / formal.

This admission (optional):

Respiratory failure during admission: Y/N.

Type 1, Type 2, Unknown.

Lowest arterial pH during admission if known.

Intubated: Yes / No.

Needed acute NIV: Yes/No.

Duration of stay in hospital (LOS).

CAT (only intervention group).

Medication on discharge (please circle): - LTOT, home NIV, SABA, SAMA, LAMA, LABA, ICS, nebs, Azithromycin,

long term oral steroids, statins, beta blockers, PD4-inhibitor, Other.

List of co-morbidities recorded with the ICD-10 classification.

In addition, the partners can collect the following optional data:

PC user.

Mobile phone user.

Work status.

Highest educational status (school, vocational, university).

Patients will be evaluated at recruitment and at the end of each of the three levels of intensity telemonitoring, at the end of the study.

The outcome measures included are described in detail in the protocol, deliverable D3.1 dated 31st March 2014.

3.5 Methods: Sample size

In total, the telemedicine intervention will be given to 2038 patients. The sample size in each region will be:

Scotland: 838 patients (670 patients + 168 patients)

Wales: 200 patients

Southern Norway: 200 patients

Galicia: 500 patients

Northern Norway: 200 patients

Berlin: 100 patients

In the case of Scotland, 670 patients will be recruited and followed-up in accordance with the study protocol, and 168 more patients will be recruited as part of the decision on deploying the service to the entire population who qualify for it in



Scotland till 30th September 2015. Clinical, organisational and economic outcomes

will be assessed only for the first 670 patients completing follow-up.

The comparator group will consist of the total population of patients fulfilling the eligibility criteria who have been treated and followed for at least one year before the implementation of the telemedicine service, from the same health units as the intervention group. This population will have similar demographics and clinical features, and its total size will be defined from admissions, the year before the implementation of the new service. In one centre (Wales), it is impossible to implement TMon across four different hospitals simultaneously with current resources. They will implement it in two of four hospitals initially, thus also allowing prospective gathering of a comparator group in the other two hospitals (with identical clinical services and similar patient demographics). This would allow additional analysis to reduce possible bias of disease progression within the same cohort if comparing admissions within them over two years.

3.6 Methods: Statistical methods

Analysis of the results will be done in accordance with the STROBE guideline for reporting of observational studies.

Firstly, the patient characteristics of the intervention and comparison group will be compared and tested for statistically significant differences by use of t-test and chi-square test (or non-parametric tests). Thereafter unadjusted differences in primary and secondary outcomes in the two groups will be compared by use of the same statistical tests. Finally adjustment for differences between the patient groups with regard to age and severity of illness of the patients will be made by multiple regression analysis.

The statistical analysis will be done by use of STATA13.

3.7 Results: Participant flow

Wales

In Wales, as at 30th November 2014 there were 48 patients enrolled onto the trial, of these:

19 have withdrawn.

Three have died whilst in the trial.

In addition, 58 were approached for consent and recruitment, but declined to participate. Many have specified reasons for refusal; wherever possible, these reasons are being collated, as this appears a high refusal rate, so will have implications for potential study selection bias, and also when designing future projects / service implementation.

NHS Scotland

Within NHS Scotland, a total of 21 patients have been enrolled in the United4Health programme. Recruitment started in September 2014. The split in the recruitment figures can be seen below.

NHS Ayrshire and Arran: 1 patient recruited.



NHS Lanarkshire: 1 patient recruited.

NHS Greater Glasgow and Clyde: 19 patients recruited.

Figure 21: Scotland recruitment

This section will be completed in the Final Trial evaluation.

Figure 22: Flow diagram

3.8 Results: Baseline data Describe the baseline data by referring to a table similar to Table 3 in the guideline, and comment on the results. What characterises the patients in the study? Are the groups similar and does randomisation seem to have worked well?


Table 1: Baseline demographic characteristics

Measurement Intervention Control

Sample size (n) Number Number

Age Mean (SD) Mean (SD)

Men (gender) Number (%) Number (%)

Education

No formal schooling Number (%) Number (%)

Less than primary school Number (%) Number (%)

Primary school Number (%) Number (%)

Secondary school Number (%) Number (%)

High school Number (%) Number (%)

College/University Number (%) Number (%)

Post graduate degree Number (%) Number (%)

Marital status

Never married Number (%) Number (%)

Currently married Number (%) Number (%)

Separated Number (%) Number (%)

Divorces Number (%) Number (%)

Widowed Number (%) Number (%)

Cohabitating Number (%) Number (%)

Work status

0

100

200

300

400

Oct Dec

1 1

0 1

10 19

COPD Recruitment

A&A

Lanarkshire

Renfrewshire



Measurement Intervention Control

Government employee Number (%) Number (%)

Non-government employee Number (%) Number (%)

Self-employed Number (%) Number (%)

Non-paid Number (%) Number (%)

Student Number (%) Number (%)

Homemaker Number (%) Number (%)

Retired Number (%) Number (%)

Unemployed (but able to work) Number (%) Number (%)

Unemployed (unable to work) Number (%) Number (%)

Smoker - yes/total (%) Yes/total (%) Yes/total (%)

Alcohol

Daily Number (%) Number (%)

5-6 days/week Number (%) Number (%)

1-4 days/week Number (%) Number (%)

1-3 days/month Number (%) Number (%)

Less than once/month Number (%) Number (%)

Height in cm Mean (SD) Mean (SD)

Weight in kg Mean (SD) Mean (SD)

Co morbidity

Heart diseases Number (%) Number (%)

Cerebrovascular diseases Number (%) Number (%)

Dementia Number (%) Number (%)

Chronic pulmonary disease, incl. COPD Number (%) Number (%)

Connective tissue disease/rheumatic disease Number (%) Number (%)

Ulcer disease Number (%) Number (%)

Liver disease Number (%) Number (%)

Diabetes Number (%) Number (%)

Hemiplegia Number (%) Number (%)

Renal disease Number (%) Number (%)

Cancer Number (%) Number (%)

AIDS Number (%) Number (%)

PC use Number (%) Number (%)

Mobile phone use Number (%) Number (%)

LOCAL DISEASE SPECIFIC DATA

3.9 Results: Estimation of outcomes Describe the results and the estimated improvements in primary and secondary outcomes. Are the effects statistically significant? Produce a table similar to Table 4 and Box 7 in the guideline


Table 2: Results of analyses

Outcome Intervention Control Mean difference after 6 month between groups (CI 95%)

Baseline After 6 month

Baseline After 6 month

Primary Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Secondary Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)



Secondary Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Physical function (PF) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Role-physical (RP) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Bodily pain (BP) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

General health (GH) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Vitality (VT) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Social functioning (SF) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Role-emotional (RE) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Mental health (MH) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (CI to CI)

Textbox 7 from Guidelines. Example of Description of primary and secondary outcomes

Primary outcome measure A total of 85.6% of patients in the telemonitoring group made at least one call; among these patients, adherence to the intervention was highest, 90.2%, during the first week of the study period and decreased to 55.1% by week 26. A total of 29,163 variances were generated during the study period, with a median of 21 (interquartile range, 5 to 54) per patient. No significant difference was seen between the two groups in the rate of the primary end point, which occurred in 432 patients (52.3%) in the telemonitoring group and in 426 patients (51.5%) in the usual-care group (difference, 0.8 percentage points; 95% confidence interval [CI], −4.0 to 5.6; P = 0.75 by the chi-square test) (Table 2). The hazard ratio for the primary end point with telemonitoring versus usual care was 1.04 (95% CI, 0.91 to 1.19). Secondary outcome measures No significant differences were seen between the two groups with respect to the secondary end points (Table 2). Readmission for any cause occurred in 407 patients (49.3%) in the telemonitoring group and 392 patients (47.4%) in the usual care group (difference, 1.9 percentage points; 95% CI, −3.0 to 6.7; P = 0.45 by the chi-square test). The hazard ratio for readmission for any cause with telemonitoring was 1.06 (95% CI, 0.93 to 1.22). A total of 92 patients (11.1%) in the telemonitoring group and 94 patients (11.4%) in the usual-care group died during the 180-day study period (difference, −0.2 percentage points; 95% CI, −3.3 to 2.8; P = 0.88 by the chi-square test). The hazard ratio for death was 0.97 (95% CI, 0.73 to 1.30). Readmissions for heart failure, the number of days in the hospital, and the number of readmissions were also similar in the two groups (Table 2). Kaplan–Meier time-to-event curves for the composite end point of readmission or death from any cause, as well as for each component separately, did not reveal a significant difference between the two groups (Fig. 2).

3.10 Results: Ancillary analyses Describe the additional, ancillary analysis made in the project. Describe results of statistical analysis in relation to Table 4 (see above). Describe results of inclusion of covariates. Describe results from subgroup analysis.

This section will be completed in the Final Trial evaluation

3.11 Results: Adverse events Describe adverse events in the two groups, as in Table 6




Table 3: Adverse events

Intervention Group

Control Group P value

Morbidity, No (%)

Overall

Major

Minor

Mortality, No (%)

3.12 Discussion of findings

3.12.1 Scotland

Planning & change management

The scale of change required to implement the technologies within U4H is significant, and required significant consultation and engagement with a wide range of stakeholders to reach consensus and development of new methods for collaboration. This has been vital to ensure implementation, but has been more time consuming than anticipated, and required a longer project lead time to prepare for “go live”.

Workforce

New ways of working and new equipment need to be accompanied by training for those who will be involved both within the professional workforce and for users and carers. An earlier review of the human and technological capabilities would have speeded up this process, and careful consideration given to best methods of releasing clinical staff to attend and participate in training and workshops.

Clinical staff can be sceptical of new technology, and only became more engaged once technology had been tested and was ready for go live.

Organisational Change

Securing sustainable culture change and on-going senior financial commitment to a deployment project of this nature & magnitude in a changing financial, operational and strategic business environment with conflicting demands such as the NHS remains a challenge. Project plans have had to be continuously evaluated in real time, and adapted as circumstances and local contexts alter. Financial pressures remain within the project, and mitigation planning is underway.




4. Domain 4: Patient perspectives

4.1 Aim of study and the instrument used.

The WSD questionnaire[15,16] on patient acceptability is used in the study to assess the perception of the telemedicine service of the patients in the intervention group. This instrument was also used in the Renewing Health project; however the questionnaire has not been published yet, and the validity and reliability of this is still under consideration. The decision to use this questionnaire was based on the lack of a more appropriate and validated questionnaire, comparability reasons (comparison with WSD and RH projects), and the fact that the authors of the questionnaire have declared that it will be published by the end of 2013.

The questionnaire includes 22 items regarding:

Utility of the “kit”.

Effect on health status.

Effect on health care/social care.

Privacy.

Suitability of the kit.

Satisfaction with the kit.

These data will be collected for the first 100 patients in the intervention group in each region. In Scotland, this will also be collected for the last 100 patients.

The number of patients who were screened but not included in the study, and the underlying reasons, will be registered and analysed with a view to identify patient subgroup populations who are currently excluded from the provided services.

Such classification of reasons for non-participation would be of help to identify existing barriers to provision of telemonitoring services to patients with chronic conditions, and to work further to overcome the ones which are not patient-related[14]. The following reasons for non-participation will be examined:

Patient refuses the use of devices - Patient refuses participation in the study in general (refuses to be

monitored, to participate in an “experiment”, etc). - Other reasons please specify (open space).

Logistic / technical limitations - No network coverage (broadband, 3G, 4G...). - Patient not living in the area receiving healthcare coverage by the hospital,

or about to leave this area during the study period. - Patient who is to be transferred in a different health centre (including

nursing home) where the intervention (telemonitoring) cannot be carried on. - Other technical reasons please specify (open space).

Clinicians assessment - Patient is unable to communicate (physical or cognitive condition). - Patient not totally reliable for using the device (not meeting requirements

for proper use and conservation of equipment and devices). - Other: please specify (open space).



4.2 Data collection Describe when the study was made. Describe how patients were approached. Present response rate. Refer to the description of participants in domain 3.


4.3 Subscales Describe the patients’ acceptability of the telemedicine application by referring to the estimated subscales. Produce a table similar to Table 7. (Subscales can be produced by professor Vassilis Aletras).


Table 4: Estimated subscales based on respondents answers to SUTAQ

Subscale Intervention After 3 months

Intervention After 6 month

Mean difference after 6 months (CI 95%)

Enhanced care Mean (SD) Mean (SD) Mean (CI to CI)

Increased accessibility Mean (SD) Mean (SD) Mean (CI to CI)

Privacy and discomfort Mean (SD) Mean (SD) Mean (CI to CI)

Care personal concerns Mean (SD) Mean (SD) Mean (CI to CI)

Kit as substitution Mean (SD) Mean (SD) Mean (CI to CI)

Satisfaction Mean (SD) Mean (SD) Mean (CI to CI)

4.4 Results from CFA May not be relevant Present results from the confirmatory Factor Analysis (CFA). (CFA can be produced by professor Vassilis Aletras).


4.5 Effects of explanatory variables May not be relevant Present results from multivariate regression analysis of the effects of different explanatory variables.






5. Domain 5: Economic aspects

5.1 Viewpoint

The economic analysis will be made with a societal perspective on costs, thus changes in the costs of the patient, and of primary and secondary care will be included.

In accordance with Drummond et al. (2005), the total costs per patient will be estimated in both the intervention and the control group. For the telemedicine patients, this will be estimated as the sum of the costs of producing the telemedicine intervention and the costs of the resources used in the healthcare sector in general (inpatient or outpatient care, ED, other healthcare contacts or medication). For the patients in the control group, the costs of the resources used in the healthcare sector in general will be estimated. Based on the estimated mean costs in the two groups, the difference will be identified and tested for statistical significance. If the telemedicine intervention reduces the patients’ use of healthcare in general during the period of 12 months, the hope is that these savings (S) will exceed the costs of the telemedicine interventions (C), and thereby result in a total reduction in the costs per patient.

5.2 Selection of economic analysis

A cost-effectiveness analysis will be carried out because the intervention can affect both patient health and costs in accordance with Drummond et al. (2005)

5.3 Patient population

Described in domain 1 and 3.

5.4 Comparators

Described in domain 1.

5.5 Range of costs and measurement,

The following economic indicators will be collected for all patients:

Number of admissions (including readmissions).

Number of bed days (days of hospitalisation).

Number of GP visits.

Number of visits to emergency department.

Number of primary care contacts.

In addition, the following information will be collected for the first 100 patients: (and for the last 100 patients in Scotland):

Number of contacts to the patient by use of telemedicine devices.



Number of times monitoring the patient's health by use of telemedicine devices

Type of health professional.

Average duration of contacts / monitoring to the patient.

Finally the following information will be collected for each region:

Price of the telemedicine applications.

Investments in infrastructure or training.

5.6 Prices Produce a table similar to Table 10. Describe also the sources of the price information, e.g. time prices based on average salary for nurses at the specific hospital or national DRG reimbursement rates.

Table 5: Prices used in the calculation of costs (€, 2011-prices)

Type of costs Price per unit

Investment and running costs:

- Physical change of buildings €€ in total

- Technical infrastructure €€ in total

- Time used by staff:

- Nurses €€ per hour

- Medical doctors €€ per hour

- Secretary €€ per hour

- Staff time used by home care nurse €€ per hour

- Rent of telemedicine device €€ per Briefcase

- Time used by patients €€ per hour

- Time used by relatives €€ per hour

- Transport €€ per kilometre

Effects on patients use of health care:

- Readmissions €€ per readmission

- Inpatient days €€ per day

- Outpatient visits €€ per visit

- GP visits €€ per visit

- Emergency department visits €€ per visit

This section will be reviewed and completed in the Final Trial evaluation.

5.7 Average use of resources Describe the average use of resources for the two patient groups and comment on the main



differences and. statistically significant differences. Produce a table similar to Table 12.


Table 6: Average use of resources per patient in the Intervention and Control Groups

Type of costs

Mean use per patient in

Intervention Group

Control Group

Running costs of the telemedicine service and comparator:

- Time used by staff on education of patients ## min. ci: ##-##

- Time used by staff at the call centre ## min. ci: ##-##

- Number of tele-consultations # ci: ##-##

- Number of inpatient days # days ci: ##-## # days ci: ##-##

.......

- Time used by patients ## min ci: ##-## ## min. ci: ##-##

- Time used by relatives ## min ci: ##-## ## min. ci: ##-##

-

Effects on patients’ use of health care:

- Number of readmissions #.# readmis. ci: ##-## #.# readmis. ci: ##-##

- Length of stay for each readmission #.# days ci: ##-## #.# days ci: ##-##

- Staff time used by home care nurse ### min. ci: ##-## ### min. ci: ##-##

- Number of contacts to GP #.# contacts ci: ##-## #.# contacts ci: ##-##

- Number of contacts to emergency doctor #.# contacts ci: ##-## #.# contacts ci: ##-##

5.8 Measured effects and benefits Refer to domain 3 for effects on e.g. SF-36, readmission Produce a table with effects on SF-6D for intervention and control groups. Test for statistical significance.


5.9 Average costs Describe the differences in the average costs per patient in the two groups. Comment on statistically significant differences. Produce a table similar to Table 15.




Table 7: Average costs of the treatment per patient in the intervention and control group (€, 2011-prices)

Type of costs

Mean cost per patient in Intervention

Group

Confidence interval

Mean cost per patient in

Control Group

Confidence interval

Investment in the telemedicine application

- Physical change of buildings €####

- Technical infrastructure €####

- Education of the staff €####

Total investment costs €#### ci: ##-##

Running costs:

- Staff €#### ci: ##-## €#### ci: ##-##

- Telemedicine devices €#### ci: ##-##

- Inpatient days €#### ci: ##-## €#### ci: ##-##

- Readmissions €#### ci: ##-## €#### ci: ##-##

- Emergency department visits €#### ci: ##-## €#### ci: ##-##

- Home care nurse €#### ci: ##-## €#### ci: ##-##

- GP visits €#### ci: ##-## €#### ci: ##-##

- Transport €#### ci: ##-## €#### ci: ##-##

Total running costs € €#### ci: ##-## €#### ci: ##-##

Time costs (lost productivity):

- Time used by patients €#### ci: ##-## €#### ci: ##-##

- Time used by relatives €#### ci: ##-## €#### ci: ##-##

Total time costs €#### ci: ##-## €#### ci: ##-##

Total costs €#### ci: ##-## €#### ci: ##-##

5.10 Incremental cost-effectiveness Estimate the incremental cost-effectiveness of the intervention, e.g. the incremental cost per gained QALY and describe the results. Produce a table similar to Table 16.


Table 8: Incremental cost-effectiveness rations (ICER) in €, 2011-prices

Case Number of patients Mean ICER Confidence interval

Base case XXX €#### ci: ## - ##

Men XXX €#### ci: ## - ##

Women XXX €#### ci: ## - ##

Patients aged > 70 XXX €#### ci: ## - ##

Patients aged < 71 XXX €#### ci: ## - ##



5.11 Sensitivity analysis Present analysis of sensitivity of the results with regard to parameters that are uncertain.


5.12 Results from the business case Describe the results from the business case. Does use of the intervention produce a net gain or a net expenditure for the relevant institution? Produce a table similar to Table 17.


Table 9: Estimated expenditures and revenue for hospital x of implementation of telemedicine for xxx patients (€, 2011-prices)

Type of costs Total expenditures or revenue

Expenditures:

- Education of the staff € ####

- Physical change of offices € ####

- Telemedicine devices € ####

- Inpatient days € ####

- Readmissions € ####

- Outpatient visits € ####

Total expenditures € ####

Reimbursement

- DRG value of inpatient activity € ####

- DRG-value of inpatient activity € ####

Total reimbursement € ####





6. Domain 6: Organisational aspects

6.1 Method

Data will be collected by interview with the health professionals involved in delivering the telemedicine interventions.

The following indicators will be collected[17]:

Effects on work processes: - Workflow: Effects on number of patients treated, procedures performed,

etc. - Staff: Changes in distribution of work (task shifting). - Resources: Changes in working hours for each profession. - Training: Time spent on training to learn to use the application. - Internal communication. - External communication.

Effects on structural outcomes: - Description and number of units collaborating in the production of the

service. - Changes in organisation of generalist and specialist tasks. - Changes in geographical spread. - Changes in time spent on travel.

Cultural outcomes: - Staff attitudes towards the application. - Staff experiences with the use of the application. - The experiences of the clinical managers. - The clinical managers view of the barriers and facilitators to adoption of the

telemedicine service

6.2 Process: Work flow Describe changes in the work flow. Produce a figure similar to Figure 4.




Figure 23: Patient care pathways

6.3 Process: Staff Describe the staff involved, their training and task shifting.


6.4 Process: Communication Describe changes in internal and external communication.


6.5 Structure Describe organisations involved and organisational changes.


6.6 Culture Describe the experiences and perception of the staff.




Referral from: List1

List2 etc

Event (Randomisati

on

TELEMEDICINE

T T

O

T

O O O O O O

T T O O

O T

CONVENTIONAL

= Telemedicine consultation = Outpatient visit

Treatment completed

Treatment completed



7. Domain 7: Socio-cultural, ethical and legal aspects

7.1 Methods Describe methods used for data collection.


7.2 Ethical issues Describe ethical issues related to the use of the telemedicine application and produce a table similar to Table 19


Table 10: Table for reporting of ethical issues

Issue How issue was addressed Dates Evidence

Patient autonomy Eg Consent to treatment

Month 3 Eg A patient information pack was created, nurses were trained to deliver oral guidance with the written information, and patients’ consent was recorded in writing. A 2 week cool-off period was introduced to allow patients to withdraw after considering the written guidance provided by nurses.

Access and equity

Normative Codes

Assessment of risk and benefit

7.3 Legal issues Describe legal issues related to the use of the telemedicine application and produce a table similar to Table 20


Table 11: Table for reporting of legal issues


Clinician accreditation

Eg Review of all accreditations for nurses

Month 1 Eg Found that nurses needed to prescribe certain treatments – accreditations changed (link to relevant code)

Device certification




Information Governance

Eg Review of procedures

Month 1 Eg Firewalls required adjustment; access protocols revised; patient access ensured (reference to new protocols)

Professional liability

7.4 Socio-cultural issues Describe socio-cultural issues related to the use of the telemedicine application and produce a table similar to Table 21


Table 12: Table for reporting of social issues

Issue Key findings Evidence

Changes in patient’s roles Eg Receiving their treatment at home to a regular timetable enabled patients to stay in the labour force as they did not need to take time off to visit clinics.

Eg Questionnaires to patients, interviews with professionals, report from senior doctor. 70% of those in work reported this benefit.

Patient’s relatives and others

Societal, political and context changes

Changes in responsibilities

Gender issues - equity



8. Transferability assessment

8.1 Assess transferability of clinical effects Assess and discuss the transferability with regard to scalability and generalisability


Table 13: Domain 2-3: Safety and clinical outcomes

Scalability Compare demographic characteristics with national data

Determine differences and asses how that would influence results on a national basis

Generalisability Widening of inclusion criteria

Assess if other types of patients (i.e. lower or higher severity of disease) will gain more or less compared to trial patients

8.2 Assess transferability of economic effects Assess and discuss the transferability with regard to scalability and generalisability


Table 14: Domain 5: economic outcomes

Scalability Assess what would be necessary if

intervention should be scaled up within the

country. How many telemedicine centres,

how many patients etc.

Calculate the consequences in terms

of costs/patient

Generalisability Assess what would happen if inclusion

criteria were widened. How many patients

would benefit, how many centres would be

necessary etc.

Calculate the consequences in terms

of cost/patient and QALYs

8.3 Assess transferability of organisational effects Assess and discuss the transferability with regard to scalability and generalisability


Table 15: Domain 6: Organisational aspects

Scalability Assess whether organisational aspects are unique for pilot within country

Describe how it is unique and what would be necessary for other regions if they decided to implement the telemedicine solution

Generalisability Assess if organisational changes is necessary for broadening inclusion criteria

Discuss what would be necessary for the organisation, if inclusion criteria were broadened – and thus more patients included



Appendix A - References

i COPD patients benefit from home monitoring. Brit J Healthcare Computing and Information Management. 2006;23:28.

ii Dale J, Connor S, Tolley K. An evaluation of the west Surrey telemedicine monitoring project. Journal of telemedicine and telecare. 2003;9 Suppl 1:S39-41.

iii Vitacca M, Bianchi L, Guerra A, et al. Tele-assistance in chronic respiratory failure patients: a randomised clinical trial. The European respiratory journal. Feb 2009;33(2):411-418.

iv Vontetsianos T, Giovas P, Katsaras T, et al. Telemedicine-assisted home support for patients with advanced chronic obstructive pulmonary disease: preliminary results after nine-month follow-up. Journal of telemedicine and telecare. 2005;11 Suppl 1:86-88.

v Steventon A, Bardsley M, Billings J, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. Bmj. 2012;344:e3874

vi Pinnock H, Hanley J, Lewis S, et al. The impact of a telemetric chronic obstructive pulmonary disease monitoring service: randomised controlled trial with economic evaluation and nested qualitative study. Primary care respiratory journal : journal of the General Practice Airways Group. Sep 2009;18(3):233-235.

vii Sorknaes AD, Bech M, Madsen H, et al. The effect of real-time teleconsultations between hospital-based nurses and patients with severe COPD discharged after an exacerbation. Journal of telemedicine and telecare. Nov 13 2013.

8 Hendy J, Chrysanthaki T, Barlow J, et al. An organisational analysis of the implementation of telecare and telehealth: the whole systems demonstrator. BMC health services research. 2012;12:403

9 Flay BR. Efficacy and effectiveness trials (and other phases of research) in the development of health promotion programs. Preventive medicine. Sep 1986;15(5):451-474

10 Campbell B, Stainthorpe AC, Longson CM. How can we get high quality routine data to monitor the safety of devices and procedures? Bmj. 2013;346:f2782

11 Goldberger JJ, Buxton AE. Personalized medicine vs guideline-based medicine. JAMA : the journal of the American Medical Association. Jun 26 2013;309(24):2559-2560

12 Al-Shorbaji N, Geissbuhler A. Establishing an evidence base for e-health: the proof is in the pudding. Bulletin of the World Health Organization. May 1 2012;90(5):322-322A

13 Rabe KF, Hurd S, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. American journal of respiratory and critical care medicine. Sep 15 2007;176(6):532-555

14 Sanders C, Rogers A, Bowen R, et al. Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study. BMC health services research. 2012;12:220

15 Steventon A, Bardsley M, Billings J, et al. Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial. Bmj. 2012;344:e3874

16 Bardsley M, Steventon A, Doll H. Impact of telehealth on general practice contacts: findings from the whole systems demonstrator cluster randomised trial. BMC health services research. 2013;13:395.



17 REgioNs of Europe WorkINg toGether for HEALTH. The Renewing Health project. 2013. Accessed 17/11/2013

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