UNIversal solutions in TElemedicine Deployment for European HEALTH care. Deliverable D8.6 Intermediate Trial Report - CHF Version 1.

Transcription

1 ICT CIP Competitive and Innovation Programme UNIversal solutions in TElemedicine Deployment for European HEALTH care Work Package: (Grant Agreement N ) Deliverable D8.6 Intermediate Trial Report - CHF Version 1.0 WP8 Version & Date: v1.0 / 16 th March 2015 Deliverable type: Distribution Status: Author: Reviewed by: Approved by: Filename: Abstract Report Public Ane Fullaondo John Oates Janne Rasmussen D8.6 v1.0 United4Health Intermediate Trial Report - CHF This interim trial report describes the key aspects of the Congestive Heart Failure (CHF) arm of the United4Health Project in each of the four pilot sites across Europe, namely Scotland (UK), Slovenia, Northwest Moravia (Czech Republic) and Basque Country (Spain). Key Word List Congestive Heart failure (CHF), telemonitoring, scale-up, implementation The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability.

2 Executive Summary This interim trial report describes the key aspects of the Congestive Heart Failure (CHF) arm of the United4Health project in each of the four pilot sites across Europe, namely Scotland (UK), Slovenia, Northwest Moravia (Czech Republic) and Basque Country (Spain). Advances in treatment for CHF have resulted in reduced length of hospital stay, and, in some cases, the avoidance of hospital visits, so the demand for home care services has increased. In this context, the design of new processes, such as telemonitoring, that improve the quality of life of patients with CHF and diminish clinical care burden, is necessary. These alternative models typically involve ICTs, and may include self-monitoring and training delivered via telemonitoring technology. Although some randomised controlled trials based on telemonitoring show that patient s health status is improved, there is no great evidence on successful implementation of this type of model. The main unanswered questions are: What population can benefit from telemonitoring? Which measurements are most appropriate and useful to monitor symptoms? The optimal duration for comprehensive telemonitoring on an ongoing basis. Who has the main responsibility for patient s follow up to design a costeffective and sustainable intervention? Which are the main barriers and facilitators when scaling-up a telemonitoring intervention? Key points to note within this interim report include: All trial sites have implemented telemonitoring interventions that aim to address these key questions. All sites have implemented similar technical solutions, but their use within the healthcare setting differs by country. All sites are currently recruiting and following up patients using telemonitoring to manage their CHF. Note that a number of key sections cannot be completed as part of this interim report, but will be described in the final report. Public Page 2 of 56 v1.0 / 16th March 2015

3 Change History Version History: th November 2014 Initial draft th January th February th March th March 2015 Version Changes 0.1 Initial Table of Contents, derived from MAST domains 0.2 First draft 0.3 Revised with additional input from partners 0.4 Minor revision, Executive Summary added 1.0 Version for issue Outstanding Issues Public Page 3 of 56 v1.0 / 16th March 2015

4 Table of Contents EXECUTIVE SUMMARY 2 CHANGE HISTORY 3 TABLE OF CONTENTS 4 1. INTRODUCTION Purpose of this document Structure of the document Glossary 7 2. DOMAIN 1: DESCRIPTION OF THE HEALTH PROBLEM AND CHARACTERISTICS OF THE APPLICATION The health problem of the patients Burden of the disease Current management Scotland Basque Country Northwest Moravia Slovenia Use of the technical application Scotland Basque Country Northwest Moravia Slovenia Technical characteristics Scotland Basque Country Northwest Moravia Slovenia Requirements Scotland Basque Country Northwest Moravia Slovenia DOMAIN 2 AND 3: SAFETY AND CLINICAL EFFECTIVENESS Methods: Trial design Methods: Participants Scotland Basque Country Northwest Moravia Slovenia Methods: Interventions Methods: Outcomes 32 Public Page 4 of 56 v1.0 / 16th March 2015

5 3.5 Methods: Sample size Methods: Statistical methods Results: Participant flow Results: Baseline data Results: Estimation of outcomes Results: Ancillary analyses Results: Adverse events Discussion of findings DOMAIN 4: PATIENT PERSPECTIVES Aim of study and the instrument used Data collection Subscales Results from CFA Effects of explanatory variables Discussion of findings Observations in Slovenia DOMAIN 5: ECONOMIC ASPECTS Viewpoint Selection of economic analysis Patient population Comparators Range of costs and measurement, Prices Average use of resources Measured effects and benefits Average costs Incremental cost-effectiveness Sensitivity analysis Results from the business case Discussion of findings DOMAIN 6: ORGANISATIONAL ASPECTS Method Process: Work flow Process: Staff Process: Communication Structure Culture 49 Public Page 5 of 56 v1.0 / 16th March 2015

6 6.7 Discussion of findings Basque Country Slovenian experience NHS Scotland DOMAIN 7: SOCIO-CULTURAL, ETHICAL AND LEGAL ASPECTS Methods Ethical issues Legal issues Socio-cultural issues TRANSFERABILITY ASSESSMENT Assess transferability of clinical effects Assess transferability of economic effects Assess transferability of organisational effects 54 APPENDIX A - REFERENCES 55 Public Page 6 of 56 v1.0 / 16th March 2015

7 1. Introduction 1.1 Purpose of this document This document contains the initial collection of data for the MAST domains for the CHF 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 CHF EMR GP ICT NYHA U4H WSD WTE Congestive Heart Failure Electronic Medical Record General Practitioner Information & Communication Technology New York Heart Association United4Health Whole System Demonstrator (UK trial) Whole Time Equivalents (for staff) Public Page 7 of 56 v1.0 / 16th March 2015

8 2. Domain 1: Description of the health problem and characteristics of the application 2.1 The health problem of the patients Congestive Heart Failure (CHF) is a complex syndrome characterised by the inability of the heart to expel sufficient amounts of blood needed for the metabolic requirements of different organs. As a result, the typical symptoms affecting patient with CHF are dyspnea and fatigue at rest or with reduced physical effort, and loss of appetite, which sometimes appear gradually over days or weeks. In addition, neurohormonal mechanisms produce liquid retention, resulting in a reduction of urine volume (occasionally not perceived by the patient) and the appearance of progressive oedemas, which frequently are not related to the disease by the patients and relatives due to ignorance[1]. Advances in treatment for CHF have resulted in reduced length of hospital stay, and, in some cases, the avoidance of hospital visits, so the demand for home care services has increased. In this context, the design of new processes that improve the quality of life of patients with CHF and diminish clinical care burden is necessary. The current healthcare model is based on the management of acute destabilisation of chronic patients by hospitalisation, maintenance of a stable health state, and early diagnosis of decompensation[1,2]. These alternative models typically involve ICT, and may include self-monitoring and training delivered via standard telephone or more advanced telemonitoring technology. Home telemonitoring allows the clinical professional to follow up on the health status and biological constants of patients at home using ICTs[3,4,5,6,7]. By keeping the patient at home, the white coat effect is avoided, and the real-time assessment of monitored parameters is possible, pushing the patient to interact with the telemonitoring system, promoting self-care and enabling bi-directional communication between patient and professional more frequently than the conventional and periodic follow up. Home telemonitoring is not intended to replace health professional care or visits, but rather to enhance the level of care[6,8,9,10,11]. 2.2 Burden of the disease Epidemiological studies indicate that the prevalence of CHF is considerably high, affecting 10% of the population older than 70 years old[12]. Over the last decade, the annual number of hospitalisations has increased from 800,000 to over a million for HF as a primary diagnosis, and from 2.4 to 3.6 million for HF as a primary or secondary diagnosis[13]. Approximately 50% of HF patients are rehospitalised within six months of discharge; with the aging of the population, this trend will continue to rise[14,15]. Due to the ageing population and the increased survival of acute cardiac diseases, CHF is becoming more common, representing a public health problem. As the prevalence of CHF grows with the ageing of populations, it will become increasingly difficult to maintain the quality of care[1]. Recent trials have shown that the patients, after Public Page 8 of 56 v1.0 / 16th March 2015

9 hospitalisation for HF, present 30-day, 1-year and 5-year mortality rates of 10.4%, 22% and 42.3% respectively[16]. Healthcare costs for CHF are at least two-fold higher than in the general population, mostly due to the high consumption of human resources caused predominantly by repeated and lengthy admissions to hospital[17]. Projections show that by 2030, the total cost of CHF will increase almost 120% (reaching $70 billion for USA)[18]. Despite advances in its treatment, CHF results in poor life expectancy, impaired quality of life, and repeated hospitalisations, so it is a considerable clinical, societal and economic burden[19,20]. 2.3 Current management Scotland Incidence & prevalence of CHF Hospital admissions for heart failure have steadily increased, with CHF one of the most common reasons for admission in older people in Scotland. Across Europe, there has been a general decline in mortality from cardiac conditions, with death rates in Scotland falling by around 40% since The prevalence of heart failure, however, is the one cardiac condition which continues to rise. This is due to changing demographics (e.g. ageing population) and improved survival from cardiac conditions in earlier life. Additionally, people are living longer with heart failure due to improved management of existing cardiac conditions and specialist heart failure care including Specialist Heart Failure Nurses. The predominant causes of heart failure are coronary artery disease, hypertension, valve disease, and cardiomyopathies. Common symptoms include increasing breathlessness and fatigue, as well as fluid retention. It is a progressive condition, and in an ageing population it is often present in conjunction with multiple comorbidities, which bring a multitude of additional symptoms, In order to determine the best course of therapy within NHS Scotland, the stage of heart failure is assessed according to the New York Heart Association (NYHA) functional classification system 2 This system relates symptoms to everyday activities and the patient's quality of life. Management of heart failure The management of heart failure is multifaceted, and requires significant efforts by patients and healthcare providers alike to optimally manage the condition within multi-professional systems of care. Optimal treatment for heart failure due to LVSD (left ventricular systolic dysfunction) includes a combination of complex pharmacological therapies, behavioural modification, and clinical interventions 3. The management of people living with heart failure requires ongoing monitoring and frequent adjustments to treatment based on symptoms, in line with national and General Registrar for Scotland 2011 Sign (Scottish Intercollegiate Guidelines Network) Guidelines, 95 Scottish Intercollegiate Guidelines Network 2007a Public Page 9 of 56 v1.0 / 16th March 2015

10 international guidelines. The management of people with HF-PEF (preserved ejection fraction) is challenging for the multi-disciplinary team as there are currently no evidence-based guidelines. Better Health, Better Care Action Plan 4 suggested that in order to provide effective healthcare, the challenge is to provide ongoing continuous care with an emphasis on anticipatory care rather than reactive care. It suggested that specialist holistic care will provide real benefits to those with long term conditions such as heart failure. A high level of specialist care in partnership with the multi-disciplinary team has been proven to reduce readmission rates from heart failure. Specialist Heart Failure Nurses are at the forefront of delivering this continuity of care and anticipatory approach by delivering specialist follow up immediately after discharge. Patients are reviewed by specialist nurses in a variety of settings: hospital wards, outpatient clinics, satellite clinics, and in their homes. Most Specialist Heart Failure Nurses also offer telephone support for patients, carers and GPs to access advice regarding symptom management. The model of service delivery varies throughout the country depending on geographical location and available resources. Investigations and treatment are based on current national and European clinical guidelines: Scottish Intercollegiate Guidelines Network (SIGN), National Institute of Clinical Excellence (NICE). Specialist Heart Failure Nurses have a fundamental role in managing and monitoring these treatments, and facilitating self-management strategies Basque Country Current management of CHF in the Basque health system is mainly based on both a close follow-up at hospital discharge, and enhancing patient empowerment by primary care nursing. Concerning follow-up, first the ehealth centre (composed of nurses) calls the patient hours after hospital discharge and investigates patient s health status following a validated questionnaire. According to the answers received, the patient visits the health centre (GP or GP nurse) within hours, hours, or one week. During this visit, the GP and the GP nurse are responsible for clinical assessment, lab tests, follow-up planning and patient s empowerment. One month after hospital discharge, the patient visits the cardiologist in the health centre, who revises the pharmacological treatment, lab tests and ECG. Once the patient is stable, he/she visits the GP and the GP nurse on a six-month and three-month basis respectively. Although some telemonitoring experiences exist within the Basque health system, there is no an integrated care pathway implemented including telemedicine. Therefore, United4Health project becomes a great opportunity to change the current organisational model and incorporate remote telemonitoring. 4 Scottish Government 2008a Public Page 10 of 56 v1.0 / 16th March 2015

11 2.3.3 Northwest Moravia Current management of CHF at University Hospital Olomouc (Northwest Moravia) is in accordance with Czech Society of Cardiology Guidelines for the Diagnosis and Treatment of Chronic Heart Failure. After discharge from hospital, there are visits to outpatient department normally every three months to check the patient s status, clinical outcomes, and to adjust medication and treatment Slovenia Current management of the CHF at the General Hospital Slovenj Gradec (SB-SG) and the Healthcare Centre Ravne (RavKor) is based on self-management of CHF, supported by regular visits to specialist outpatient clinics in SB-SG and healthcare centres in the Koroška region. One of them is RavKor. Self-management of CHF patients within their home environment Patients measure their blood pressure and heart rate 2-3 times a day and their body weight once a day. All patients have to keep written records on their measurements, and make records of their own assessment of their health status (range 1-10) in a dedicated notebook. The records are checked by a CHF specialist at regular scheduled visits, and serve as a base for further treatment of the patients. All the CHF patients are invited to regular periodic control visits by the CHF specialist at the CHF department at SB-SG. The frequency of the visits depends on the patient s health condition. The first visit is usually 2-4 weeks after his/her discharge from hospital. Stable chronic patients come every six months. In case of acute health deterioration, the period is 2-3 weeks or even shorter. CHF patients are encouraged to call the CHF department by phone to report their health condition. In accordance with the assessed condition, the doctor adjusts the frequency of control visits, and if needed also corrects the therapy. Many patients have difficulties to adhere to the prescribed diet, and do not always follow doctor s advice on physical activity and the treatment regimen. We believe that with telemedicine support to the CHF patients, we will: Receive real-time results of the patient s self-management at home and reveal threshold exceeding values of blood pressure, heart rate, body weight, and oxygen saturation. Increase motivation of the patients to cooperate with the therapy and the diet. Reduce, in the long-term, the number of CHF patient visits to the specialist centre, in particularly for those patients who visit the specialist more frequently than every six months. Better achieve the target values for blood pressure, heart rate, body weight, and oxygen saturation, resulting in a reduction of acute deterioration of health, the number of emergency visits to the hospital and intra IV therapies. Early detection of acute health deterioration and timely interventions should reduce the number of hospitalisations and number of hospital days. Public Page 11 of 56 v1.0 / 16th March 2015

12 2.4 Use of the technical application Scotland Within Scotland, there are three pilot sites participating in the U4H telehealth intervention approaches for CHF; Ayrshire & Arran, Lanarkshire and Greater Glasgow & Clyde (GGC). For all of the intervention sites, the telehealth solution is integrated into the existing service delivery models for management of CHF used locally. Application and use of telemonitoring to support the treatment and management of CHF across Scotland aims to: Enable early detection of deterioration due to HF, e.g. weight gain, allowing timely intervention that prevents the need for hospital admission. Increase the clinical resource capacity available within our specialist and community teams to improve HF services. Prevent & reduce unplanned crisis episodes for people with HF requiring hospital admissions / re-admissions. Introduce monitoring of essential vital signs for patients with HF to facilitate usage of heart failure medication. Improve self management by engaging, educating and empowering patients and carers to understand their own HF symptoms and increase the chance of symptoms improving. Improve clinical capacity of the heart failure nurses and specialist clinicians involved. All patients with CHF who meet the eligibility criteria will be approached by their clinician or specialist nurse 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, and using existing staff groups, enables the monitoring of alerts to augment and support the current clinical pathways offering alternative care options and different levels of monitoring intensity to staff, patients and family/carers. Heart failure nurses visit eligible 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 gained, patients will received the telehealth kit within 24 hours of being discharged from hospital. If patients meet the criteria, but are discharged before being assessed by specialist nurses, these patients are followed up at home. In Lanarkshire, the professional group who will largely be accessing the telehealth monitoring will be the Heart Failure Nursing Community 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. Public Page 12 of 56 v1.0 / 16th March 2015

13 Within Ayrshire & Arran, recruitment is from hospital for patients with a diagnosis of CHF. Referrals are accepted from ward staff, heart failure specialist nurses, cardiology consultants, community ward clinicians, and also from GPs and District Nurses following discharge from hospital. This pilot site will have access to a telecare hub for triage management, staffed mainly by clinical support staff and nursing staff. For GGC pilot, it is medical staff, ward staff, and specialist heart failure nurses from the Royal Alexandra Hospital in Paisley who will identify patients who are appropriate for the intervention. There are 1.8 WTE heart failure nurses to treat a population of over 250,000 people diagnosed with CHF. Additional nursing support has been funded by U4H project to support the clinical triage process and integration of new technology. The clinical triage model supporting telemonitoring being applied in GGC and Lanarkshire is a decentralised model. All clinical alerts are forwarded directly to nursing staff who are responsible for carrying out clinical triage for their caseload of patients, and managing alerts on a day to day bases, The potential limitations of this are that initially it can result in an increased workload for community staff managing HF patients. In contract, Ayrshire & Aran pilot is using a centralised triage service which operates through a local telecare hub. This required a shift in the role and workflow of the specialist nursing teams and administrative staff. The final level of triage across all pilot sites is carried out by nursing staff, and can result in a number of actions, such as continued observation, telephone advice, reassurance for a patient, or referrals to a clinician who can carry out a face-to-face assessment. It is envisaged that patients with CHF will continue to be visited by healthcare professionals and attend medical appointments. However, some of these visits may not be needed for patients using the telehealth service, as key information (i.e. vital signs, medication reviews) are in the telehealth system, and can be accessed directly and managed quickly. Health professionals providing this service can better tailor it to the needs of their patients, knowing that all their telehealth patients get their needs met no matter what stage of CHF is evident, In addition, by taking their own readings (e.g. weight), 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 these changes, and discuss with an HCP Basque Country Patient who meets the inclusion criteria are identified during hospitalisation by the hospital nurse. If the patient agrees and signs the informed consent form, he/she is enrolled in the intervention. The technical provider will be responsible for installing devices to measure of heart rate, blood pressure, pulse-oxymetry and weight at patient's home within a week after recruitment. In addition, a personal alarm device for 24/7 real-time emergency detection will be installed. The patient will be trained to use the telemonitoring and telecare devices by the hospital nurse at discharge (a demo kit is installed in the hospital) and by the technical team at home. In parallel to the telemonitoring device installation, nurses from the ehealth Centre call patient in hours after discharge to investigate his/her health status. Depending on patient s situation, a validated protocol is activated. Public Page 13 of 56 v1.0 / 16th March 2015

14 Once the telemonitoring devices are installed at patient s home, the patient will routinely transmit his/her parameters on a daily basis during the first month. The transmission frequency will be modified by the cardiologist; it tends to decrease as the patient is stabilised. During the first month after discharge, or until the patient is clinically stable, the hospital cardiologist is responsible for patient s alarm threshold definition and telemonitoring follow-up, whereas GP and GP nurse are in charge of stable telemonitored patients. Figure 1: Follow-up after hospital discharge The telemonitoring devices collect and send the data wirelessly to the gateway located at patient's home. The gateway device transmits the data collected by the patient to the alarm management system of the Telecare Centre. The operator of the Telecare Centre checks the data sent by the patient and activates the predefined protocol agreed by a group of professionals, including clinicians, GPs, nurses, general directors and representatives of the social area. This standard protocol classifies each alarm type depending on the severity (from 1 to 5) and establishes the required actions for each situation. When clinical parameters are out of range, the operator first verifies the alarm situation by a phone call to the patient. If the alarm is validated, the operator triggers the protocol depending on the severity of the situation. The operator sends the validated telemonitoring data to the ehealth Centre via platform integration (see section 2.5.2); they then solve the alarm on their own, notify the GP or the specialist, or activate Emergency Department. If the patient uses the 24/7 real-time alarm device provided, the Telecare Centre's operator can contact the Emergency Department and/or social services. In addition, the Telecare Centre also solves any technical problems arising in the use of devices Northwest Moravia Telemonitoring of CHF in Northwest Moravia is in line with U4H study protocol. Each patient is properly educated and equipped with all the necessary devices, including weight scale, pulse oximeter, digital blood pressure monitor, and mobile gateway with dedicated software (on 8 inch Android tablets) with wireless data transmission between medical devices and gateway (via Bluetooth), and between gateway and our system servers and databases (via GPRS/EDGE/3G). A SIM card provided by the hospital is also inserted in the gateway. These telemonitoring tools made data available to the medical personnel daily, and follow the development of weight, blood oxygen saturation, blood pressure, pulse Public Page 14 of 56 v1.0 / 16th March 2015

15 plus medication and fluid intake of all patients. There are also two types of alerts generated by the software: a) if patient s clinical parameters exceed threshold values, or b) if there is uncompleted measurements. A dedicated nurse from the heart failure ambulance checks the received data on a daily basis. According to the severity of alerts, the nurse can escalate the issue to dedicated clinicians (a team of three dedicated cardiologists). There is also continuous telephone technical support for patients from two biomedical engineers, who are based in the telemonitoring centre, which itself is located in cardiology clinic of the hospital. These bioengineers also prepare sets of medical devices for patients, and educate them Slovenia Current management of CHF at the General Hospital Slovenj Gradec (SB-SG) and the Healthcare Centre Ravne (RavKor) aims to achieve the following goals: Achieve the target values of blood pressure and heart rate. Achieve and maintain an adequate body weight. Reduction of body weight of CHF patients in the terminal phase (NIHA 3-4) is a typical indicator that requires medical intervention. Adherence to the prescribed diet, reduction of salt intake, reduction of daily fluid intake (< ml), regular daily physical activity, follow-up of fluid excretion, etc. The above goals were adopted also for the telemedicine service. CHF patients take daily weight, blood pressure and oxygen saturation measurements using the corresponding mobile measuring devices. Each patient has a smart mobile phone that serves as a mobile gateway. Data are transferred from the measuring devices to the gateway via Blue-tooth, and then over a mobile network to a telemedicine service centre at SB-SG. Telemetrically collected data are stored on a dedicated server that is a part of the hospital network infrastructure, and processed by the server application as described below. Telemetrically collected data are accessible through the LAN or remotely by VPN access. The received data values are assessed by the server telemedicine application against set thresholds and trends. If the received data exceeds the individually set threshold limits (set by the medical specialist), a telemedicine centre coordinator (a nurse) receives a warning . (Optionally: if the coordinator does not confirm receipt of the , it is forwarded also to the medical specialist on duty.) The coordinator calls the patient by phone to get more information on the background of the out-of-range data values. The measurements are repeated if there is any doubt on data reliability. If the measurements confirm a deteriorated condition, or they are indicated by the patient him/herself, the coordinator consults the specialist on duty and informs him/her on the findings. The specialist decides on the action to be taken by the patient. This could be: advice, change in medication / treatment, a visit to his/her GP, a visit to the hospital clinic during regular working hours, or an emergency visit to the hospital. The information is conveyed to the patient by the coordinator over a phone, and later as a written report by a surface mail. Every phone call, advice, change in therapy, home visit or other action is registered in the patient s electronic record. Public Page 15 of 56 v1.0 / 16th March 2015

16 A mobile team of field nurses is planned to visit those patients who are willing to cooperate, but do not feel capable of managing the telemedicine devices by themselves. 2.5 Technical characteristics The patient at his home uses the provided devices to measure his/her heart rate, blood pressure, pulse-oximetry and weight (Figure 2) in accordance with the treating physician s prescription, but at least once per week. Reminders will be sent if the centre does not receive any measurements for longer than a week, including a specific question: Do you feel worse than last week?. The telemonitoring devices used by the patient collect the data and send them to the gateway device wirelessly. The gateway device transmits data collected by the patient to the system server. An operator checks the data sent by the patient, accessing them through the relevant portal. In case of clinical parameters out of normal range, as set by the treating physician for each patient, the system s software detects the alert situation; the operator manages it following the standard protocol set by the physician. In case of alert situation, the operator contacts the patient to verify the alert. If the alert is verified, depending to its severity, the operator contacts the reference clinician for that patient, or follows the alert procedure. For the proper management of the alert situation, after the notification by the operator, the clinician accesses the relevant portal to check the patient data and take the appropriate actions. Clinicians can access the portal to monitor patients health conditions any time they need, and not only in case of alert. Figure 2: CHF telemonitoring system architecture The necessary telemonitoring devices included in the intervention are: Pulse oximeter. Blood pressure monitor. Public Page 16 of 56 v1.0 / 16th March 2015

17 Digital weight scale. The sections below provide a description of the technical solutions in each region 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 heart failure. There are different types of solution, each of which is compliant with the technology requirements of the project. Pilot site NHS Lanarkshire The software solution installed in NHS Lanarkshire is Simple Telehealth, also known as Florence, which is an national product developed by NHS England 5. Essentially this is a text message service that sends information, collects data, and links directly to clinician s computer software. The software displays the data, 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 systems supports SMS texts from patients own mobile device without the need for software download. Patients or carers supply blood oximetry and temperature readings, and reply 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 heart failure clinical algorithm and decision tree developed by clinical staff; they provide an alert to staff that a patient needs to be reviewed. The Florence system is shown below and 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 instructions, reassurance or reminders of appointment time, or additional health coaching messages. 5 Public Page 17 of 56 v1.0 / 16th March 2015

18 Pilot Site - Ayrshire and Arran Figure 3: Florence system The solution being used by Ayrshire & Arran for heart failure is Medvivo s Home Pod 6. The Homepod 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 medical devices used for the heart failure work stream are A&D Bluetooth blood pressure monitor, and A&D Bluetooth weight scales. The Homepod software which interacts with the patient is called the PUI or patient user interface. It supports the patient protocols and interacts with the medical devices. 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 Homepod in allowing the patient record to be set up, protocols to be configured, readings to be monitored, and triage management. There are two versions of the CUI; a window 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 Homepod 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 Homepod. After a successful transmission the data registers are emptied. Typical connection between the Homepod and the server is securely over GPRS. In areas of poor / no signal, POTS (dial up modems) are used. Connection via homebased ADSL / Internet is readily available, but generally it is policy not to use public networks for security / data compliance reasons. 6 Public Page 18 of 56 v1.0 / 16th March 2015

19 Figure 4: Homepod system Data downloads to the Homepod 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 Homepod 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 Greater Glasgow & Clyde This pilot site is deploying a software platform called Safe Mobile Care 7 (SMC). SMC is an end-to-end web based healthcare solution that uses clinically validated questionnaire sets, appropriate vital sign data capture, and medication reminders through the uses of a specially configured Smartphone or tablet device (patient's choice). It is used alongside the technology and a number of (wireless) peripherals to allow easy capture of vital signs, in particular, the pulse oximetry & temperature. An overview of the set up of Safe Mobile Care and technical characteristics is outlined below. 7 Public Page 19 of 56 v1.0 / 16th March 2015

20 Figure 5: Safe Mobile Care The HCP selects a suitable clinical questionnaire or develops 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 onto the device, the personal care plan will prompt patient to supply data from the peripheral devices. The tablet has pre-loaded questions for the patient to answer, which have been agreed by the medical and specialist nursing staff, with patients prompted to answer yes or no to the questions. Immediate feedback is sent to the patients 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. Greater Glasgow & Clyde (Renfrewshire and East Renfrewshire) have a contract with Safe Patient Systems for the supply of telehealth equipment for heart failure. All patients are issued with a Nexus tablet and peripherals such as weight scales, pulse oximeter, and blood pressure cuff, which are attached to the tablet device via Bluetooth. The device has pre-loaded questions for the patient to answer which have been agreed by the medical and specialist nursing staff, with patients prompted to answer yes or no to the questions. The outcomes are monitored by specialist nurses five days a week, nurses will then take action on the alerts which are raised. The devices / peripherals used by the patients are shown in Figure 6 below. Public Page 20 of 56 v1.0 / 16th March 2015

21 Figure 6: Devices / peripherals used by patients Basque Country Telemonitoring and telecare devices are installed at patients homes. The data (blood pressure, oxygen saturation, weight, and questionnaire on health status) are transmitted manually or via Bluetooth to the gateway, and then sent to the server which belongs to the service provider (Telecare Centre). Once the telemonitoring information coming from patient s home is validated, it is sent to the CRM where the management of processes is coordinated. nurses of the ehealth centre who are responsible for handling the CRM, while other healthcare professionals (cardiologists, hospital nurses, GPs, GP nurses) consult telemonitoring information via the electronic health record. The CRM contains the whole telemonitoring information: transmitted data, activated alarms, actions taken upon alarm activation, scores of questionnaires (Euroqol, Zarit, Barthel, EHFScBS and Yale), and tasks (who has to do what and when). However, only the most relevant information is transferred to the EHR (transmitted data, alarms and actions). Figure 7: Basque Country architecture Further information on the architecture and technical interfaces can be found in D8.2 Procured components Northwest Moravia The telemonitoring intervention at University Hospital Olomouc complies with all the criteria above related to devices, data transmission and management. Each of our patients is being equipped with the following devices: precision health scale (A&D Medical), upper arm blood pressure monitor (A&D Medical), wrist pulse oximeter (Choicemed), and Samsung Galaxy Tab There is also Android app with user Public Page 21 of 56 v1.0 / 16th March 2015

22 friendly interface that runs on the tablet as gateway (created on request by Ness solutions and services), called Medimonitor. Data and other measured values from the devices are sent to telehealth portal and stored in database. The information is then accessible for medical staff (clinicians, nurses and biomedical engineers) via web browser and secured login Slovenia Both Slovenian U4H partners (SB-SG and RavKor) use the common telemedicine service for CHF and DM patients offered by SB-SG. The service was designed by strictly following the U4H proposed system architecture for the diabetes telemonitoring service as presented in Figure 2 above (page 16). The solution is completely wireless for the monitored CHF patients. A CHF patient (1) uses three telemonitoring devices: a blood pressure meter with an incorporated heart rate meter, a weight scale, and an oximeter. Each measured value is sent from each of the devices over a Bluetooth (2) link to a gateway that is a smart phone. Data are forwarded to the regional telemedicine centre over a mobile network (3). There, data are passed to a broadband Local Area Network (LAN) and stored at the telemedicine service server. Regional centre operator monitors patient s data (5), and responds when alerted (primary level interventions), e.g. by calling the patient when the measured data is out of his/her personal specified range. A cardiologist or his/her co-worker (other healthcare professionals) is alerted by the operator (4) when an intervention at the second level is required. Family members are also informed by the regional centre operator (7) when their assistance is needed, e.g. to take their relative to see a cardiologist. All the involved parties send their feedback to the regional centre operator (7) using standard communication means (phone, , SMS, written reports). GP is not a part of the response system, as the cardiologists at SB-SG cover both secondary and primary healthcare needs. The patient has an optional communication channel (6) to contact the regional centre operator by phone. The same channel (6) is used by the regional centre operator when the patient is contacted. CHF patients using the telemedicine service take daily measurements of their weight, blood pressure, heart rate and oxygenation. Some of them provide data several times a day in the health critical days. If those values exceed the individually set threshold limits set by the medical specialist, a telemedicine centre coordinator (a nurse) receives a warning . (Optionally: If the coordinator does not confirm receipt of the , it is forwarded to the medical specialist on duty.) The coordinator calls the patient by phone to get more information on the background of the out-of-range data values. The measurements are repeated if there is any doubt on data reliability. If the measurements confirm a deteriorated condition, or they are indicated by the patient him/herself, the coordinator consults the specialist on duty and informs him/her on the findings. The specialist decides on the action to be taken by the patient. This could be: advice, change in medication / treatment, a visit to his/her GP, a visit to the hospital clinic during regular working hours, or an emergency visit to the hospital. The information is conveyed to the patient by the coordinator by phone, and later as a written report by a surface mail. Every phone call, advice, change in therapy, home visit or other action is registered in the patient s electronic record. Public Page 22 of 56 v1.0 / 16th March 2015

23 2.6 Requirements Scotland Pilot Site Lanarkshire Equipment Pulse oximeter. Weighting scales. Blood pressure device. 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 To assist in the monitoring of patients, specialist nurses are being provided with Smartphone s to access patient information, and allow immediate registration of the patient in the system. A tablet device (Samsung Galaxy) is also being provided in each of the acute hospitals to improve the technical communication between the 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 has been developed by the clinicians to provide step by step information as to what readings to supply, how to take these readings, what to expect from the Florence system, and other specific information regarding emergency contacts. Patient who have particular learning needs or complex HF issues are given more 1:1 support from the clinical team to ensure they can confidently use the SMS service and peripherals. A 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 with onsite sessions and video-conferencing with Florence team, lasting approximately six hours depending on requirement. A rolling programme will be established for new staff including a refresher course. Continued telephone support has been available to facilitate the setting up and testing of the specific protocols for each service study, and one-to-one cascading of information carried out within Lanarkshire by heart failure team leader and project manager to support the implementation. Staff within HF service currently use texting as a means of communication with patients, so are familiar with this approach. 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 a network that enables peer support from all current groups using Florence. Public Page 23 of 56 v1.0 / 16th March 2015

24 NHS Greater Glasgow and Clyde Equipment NEXUS tablet device supplied by Safe Patient Systems. Wireless peripheral devices: weight scales, pulse oximeter, blood pressure cuff. Installation and deinstallation of equipment is completed by Safe Patient systems through a third sector organisation British Red Cross. On delivery of the equipment, patients are supplied with an information booklet about the technology, contact details and information about the project, and a helpdesk number which can be used to register and report faults. Training for 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 patients 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. If necessary, patients are visited at home to provide additional training on the equipment; this is followed up with a telephone call the following day to ensure the patient is comfortable in using the equipment. If not, further training can be arranged. An information booklet for patients has been developed to provide guidance to use of the technology, emergency contacts, and how to use peripherals. Training for 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 Pilot Site: NHS Ayrshire and Arran Equipment The patient hardware required for pilot is: Medvivo Home POD (Samsung); Pulse oximeter. Weight scales. Blood pressure cuff. Software is Homepod schematic integrated service solution. Public Page 24 of 56 v1.0 / 16th March 2015

25 Training for patients Patients are introduced to the equipment by their clinician, who explains the aims and objectives of using the equipment. The patient is then given the opportunity to take various measurements / tests, such as blood oxygen saturation or blood pressure, using the PODs and other equipment / peripherals. Following agreement from the patient to use the equipment, Micromesh 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. Training for HCPs A rolling programme of awareness sessions and further in-depth training has been delivered to staff and healthcare professionals who need to use the Homepods. Microtech carry out training for staff in the CUI as and when required. This training takes about an hour, including the time to download the CUI onto required PCs. The Micromesh technician will demonstrate the CUI, showing test patient information, and goes 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 saying this, and be given the CUI User Manual. Further support is always available from the Micromesh support / helpline Basque Country Equipment and supplies The selected sensors are qualified as Health Products according to the European Directive 93/42/CEE, and have been widely used and validated worldwide proving their high reliability. The selected models are: Pulse-oximeter: Nonin 9560 Onyx II. Blood pressure monitor: A&D UA-767PBT. Gateway device: two options: - Mymedic II (Tunstall): non-mobile solution. - CarelineH@me (Saludnova): mobile solution. Training of patients Patients who meet the inclusion criteria are provided with a short presentation summarising the information of the informed consent form in order to facilitate understanding. In this visual report, the main aspects of the telemonitoring intervention are explained: what telemonitoring is, who controls the telemonitoring, possible benefits and harm, costs, etc. Public Page 25 of 56 v1.0 / 16th March 2015

26 Figure 8: Training concepts Patients are trained in the use of telemonitoring devices by hospital nurse at discharge. There is a demo kit installed in each participating hospital, so patients or their caregivers can try handling the devices. In addition, the technical staff who install the telemonitoring kit at patient s home also train patients. Patients receive a user manual (leaflet) where the most relevant information is summarised. Figure 9: Training material Hospital healthcare professionals define a plan for patient empowerment. Nurses from GP offices are then responsible for organising face-to-face sessions with patients in order to educate them on self-management. These nurses use supporting material describing different aspects of heart failure and other comorbidities, inlcuding recommendations on diet and physical activity, risk situations, detection of worsening symptoms, and drug intake to improve treatment adherence. Training of professionals Core working groups have been created in each of the geographical areas participating in the project. Each area is composed of one hospital and together with primary care health centres. Members of the core group (cardiologists, hospital nurses, GPs and GP nurses) are provided with a detailed protocol explaining all the Public Page 26 of 56 v1.0 / 16th March 2015