Minutes SIMPHS Workshop Seville - 22 April 2009 1. Introduction The workshop was attended by four external experts: - Prof. Dr. Harald Korb and Matthias Quinger (Vitaphone, Germany) - Andrew Hamilton (European Centre for Connected Health, Northern Ireland) - Peter Levene (Docobo, United Kingdom) and IPTS: - Dave Broster, Ioannis Maghiros, Fabienne Abadie, Peter Baum, Marc van Lieshout, Corina Pascu, Jose A. Valverde. Ioannis Maghiros opened the meeting, welcomed the experts and gave a brief overview of IPTS, the main focus areas of work and of the IS unit. F.Abadie then gave an introduction on the SIMPHS project, its rationale and objectives and the aims of the workshop. 2. Perspectives from ECCH on PHS 2.1 Speaker Andrew Hamilton is the acting CEO of the European Centre for Connected Health (ECCH) which was established in Belfast, Northern Ireland in early 2008. Prior to this he was the Deputy Secretary of the Department of Health, Social services and Public Safety (DHSSPS) dealing with policy. 2.2 Presentation ECCH was set up within DHSSPS to promote improvements in patient care through the use of proven technology and to fast track new products and innovation in the local health and social care system in Northern Ireland. Providing a strategic focus for the local health and social care economy it seeks to bridge the gap between market solutions that are available and which offer significant potential for improving the quality and efficiency of services and the lack of awareness about these solutions among practitioners and policy makers. It is funded by the DHSSPS. The initial focus of the ECCH is the development procurement and implementation of a remote monitoring service for chronic disease in Northern Ireland. This is a system-wide solution that goes beyond pilots, as the latter are fragmented in nature and limited in duration. The aim of the ECCH initiative is to embed technology in healthcare so as to leverage its potential to catalyse change, not only at technology level but in working practices. Beyond improving healthcare delivery, the deployment of the Remote Monitoring Service in NI is as a by-product expected to contribute to economic growth in the region as a whole. The local economic department is actively targeting the connected health field for high value investment opportunities.. The current focus of the services in the process of being procured is CHF, COPD and diabetes patients, both home-based and mobile. In the future further conditions may be tackled such as 1 stroke prevention, hypertension, telecare services (e.g. fall detection), medicinal compliance or dementia, depending on the results of the evaluation of the current services. The future strategy will include the promotion of health and well being, independent living, early intervention etc. The Department of Health decided to fund the initiative in response to the challenges posed by societal trends (ageing, chronic diseases etc.) and given the associated significant increases in demand the fact that the status quo with healthcare delivery is unlikely to be sustainable for Northern Ireland. A feasibility study was carried out in 2007 which led to the acknowledgment that unless a structure was put in place with a strategic focus, the current planning and delivery mechanisms in the health and social care system would not be capable of embracing new technologies. There was strong support from the university and industry sectors and clinicians. It was felt that the supply chain was mature enough, products were available and one could move on quickly. The ECCH initiative was therefore announced in January 2008. A. Hamilton underlined the importance of having a clear policy framework to improve healthcare efficiency and develop an early intervention strategy. The introduction of technology helps address the strategic agenda for healthcare. The ECCH works closely with the Department of Enterprise, Trade and Investment, which has provided some funding to the initiative as they considered the initiative to contribute to the innovation agenda. The Department of Employment and Learning (which has responsibility for the University sector) has also been involved. The ECH Campus brings together industry and universities in a kind of ecosystem, a role which could not be fulfilled by ECCH as the procurement process they deal with makes it difficult currently to have links with industry (i.e. respect of public procurement rules). The ECCH PHS services procurement process is not about technologies, neither is it about devices but it is about comprehensive, end-to-end services, from supply, delivery, installation, commissioning, maintenance to decommissioning and making good of equipment. A number of elements need to be delivered, including support and training, data processing, transmission and analysis of data , interfaces and triage services. Evidence is critical to the initiative and a detailed evaluation framework will be put in place and the service provider will be expected to contribute to this. As learning emerges from the evaluation process the focus of the initiative may change. Should the evaluation show that specific parts of the programme do not deliver the expected results the activities will be reconsidered. It is also expected that the system will be future-proofed i.e. a system that can be upgraded and keep pace with technological developments during the contract period. The main drivers include demographic trends, the fact that long term conditions will impact on the responsiveness of health and social care, and that more emergency admissions will be required if nothing is done. Further, social structures are changing with more and more people living alone without their supportive family networks being available or far away and this too will drive changes in health and social care systems. Greater specialisation in services may increase social costs e.g. of travel and technology could be used to reduce these for example through remote assessment. Increasing patient and user expectations about their involvement in their care and the quality, responsiveness and accessibility of services will also drive change. 2 It is debatable whether real term cash savings should be anticipated from the impact of PHS on the acute hospital sector. This will depend on local circumstances. Instead reduced utilisation may result in capacity being freed up that will help meet the increasing demand. The key benefits lie in the promotion of health and well being with greater service user engagement in the management of their own condition and the promotion of lifestyle change. This should lead to a smoother curve of hospital usage, with less peaks. Funding is needed at the start of the service procurement as well as for the transition period towards full deployment. In Northern Ireland funding has been set aside to pay the service provider. Additional funding may also be needed to meet a perceived increase in workload associated with the response to alerts. Once the contract has been agreed the funds will be allocated to the Health and social care Trusts which will then use the funds to pay the service provider. A contract will be drawn for 4 years extendable for another 2 years, after which time a new tender process will be required. It may take 2-3 years for the full benefits to emerge as the system beds in and the effects of better disease management take effect. ECCH fully expects outcomes to show patient benefits but if the evaluation shows that benefits are not commensurate to the costs some changes will be made. A number of pilots are currently being pursued to expand patient and clinician experience of the new approaches in preparation for the implementation of the main service. Experience to date with pilots indicate that patients and carers seem to be happy with remote monitoring. Patients report feeling less anxious about their condition. Clinicians generally agree that the system will contribute to patient health and well being, but are more sceptical about the impact on service utilisation. For the remote monitoring service metrics of success will be developed, e.g. contribution to quality of care, lifestyle change. The impact on the organisation will be measured and service utilisation will be tracked. A.Hamilton presented an organisation chart showing the parties involved in the initiative (see slides), 100-150 people are involved altogether. Patients are represented through the LongTerm Condition Alliance. ECCH also cooperates with professional bodies, such as those representing doctors and nurses. Champions are needed in each Trust area. Clinicians are involved in procurement process and the importance of having a clinician buy-in and corporate commitment cannot be overstated for the successful deployment of services. ECCH also liaises with universities to raise interest in the initiative. Some links have also been made to other health and social care economies (e.g. Boston, Denmark, Finland ,Republic of Ireland) to share learning, but these are at the early stage of development. In terms of data, ECCH has published the evidence base they gathered (meta analysis and smaller studies as well as RCT, on their website (study of Margareh O'Brien). A. Hamilton raised doubts on the assumptions used to arrive at market growth projections. The slow growth of the PHS market is linked to the system capacity to respond and the time it takes to set things up. While technology can do a lot, the capacity of users (patients and clinicians) to adjust to and cope with technology implementation is much lower. Further, clinicians do not always agree on benefits of PHS solutions, although the evidence base is pointing in the right direction more work is needed to develop this. As a result of all this growth is more likely to be incremental rather than explosive. 3 2.3 Discussion Docobo raised the issue of the meaning of telecare, telehealth and the lack of clarity of terminology which results in a confusing market picture. Telehealth could include health and well being, i.e. prevention and medical involvement. Vitaphone underlined the importance of the well being market, which reflects an image of youth while that of managed care is associated with disease and ageing. The wellness market can raise awareness about prevention and create demand through potential users. As such it has a huge growth potential and may push growth on the managed care market segment. Asked about the scale of the initiative, A. Hamilton explained that the plan was for services to be fully operational in some 2 years offering capacity up to 5000 patients. The service would be available throughout Northern Ireland implemented across the 5 hospital and community service Trusts and GP practices. The procurement is expected to take 18 months. The question was raised of why SMEs have been excluded from the procurement process. A Hamilton explained that they had not been excluded. But there had to be recognition of the scale of service that was to be delivered. SMEs can however be involved through subcontracting. Vitaphone underlined that it was not good for industry to have to wait for 6 years before the proof of validity of the results would be available. According to Vitaphone there are many studies, proving the benefits of remote monitoring and telecare solutions, no more studies are needed. Vitaphone has 25000 patients and can show results. Docobo feels that SMEs are penalised as they are seen as high risk although they have a very good understanding of how the service technology market is developing. SMEs are more likely to make it work as big players often pull out altogether of a market when returns do not come fast enough. Docobo underlined that one of the main problems faced in deployment of PHS systems is conflicting objectives in primary and secondary care. Clinicians are not as aware of PHS and health technology as we think. This needs to be built into training programmes. It is also difficult to get details of innovative projects, a database of pilots and projects would be useful. 3. Perspectives from Vitaphone on PHS 3.1 Speakers Prof. Harald Korb is the Chief Medical Director at Vitaphone. Prior to his work with Vitaphone, he was a heart surgeon and is affiliated with the University of Cologne. Mr Quinger is the founder of the company and active for many years in the provision of medical technology to practices. 4 3.2 Presentation and discussion Prof. Korb presented the market strategy of Vitaphone, starting with an overview of demographic and health trends in Germany. Chronic diseases are rampant and show an accelerated growth, not only in Germany but on a global scale. As an example, Germany had 5 million patients suffering from diabetes five years ago, there are 8 million already now. In some countries the acceleration rate is even higher. Prof. Korb gave as an example the United Arab Emirates were allegedly 46 % percent of the population in a certain age group are suffering from diabetes. Another example is China with 600 million diabetes patients. He did not specify the type of diabetes but mentioned as a cause the rapid changes in lifestyle and nutrition. By 2050 the world will be facing a severe diabetes crisis. He concluded by saying that "the catastrophe is not catastrophic, what is catastrophic is how we handle the catastrophe." Mr Quinger gave a brief overview of his company and its structure. A cornerstone of the success seems to be the backing by Venture Capital of Mr Hector, a founder of the software company SAP. The implementation of the initial infrastructure for the telemedicine system, the backbone, and the back-office have required significant investments. Currently the company employs 200 qualified medical professionals in Germany and around 300 globally. Vitaphone is active in 20 countries worldwide, ranging from The Netherlands to the USA, South Africa, India and China. In some of these countries Vitaphone's presence is mainly through sales representatives, in others it is more substantial. Its prime locus is in Germany, United States, Austria and the Netherlands. Prof. Korb placed telemedicine on a scale of solutions for individuals who are health conscious to individuals at risk, those suffering from acute problems and the chronically ill. The market oscillates between the consumer market and the managed care market. He presented Vitaphone as a company that provides a suite of solutions for prevention, diagnostics and therapy and offers products for both markets. At present, nearly 1 million doctor visits take place yearly in Germany due to acute chest pain, a significant part of it due to palpitations. In 85% of the cases there is no reason for concern at all. By providing a relatively cheap device (ECG card, cheque card sized) (~200 Euro) to the patient and connecting him to a central registration centre (a service offered for about ~10 Euro per month) a patient can be monitored and in case of emergency his data can be analysed quickly in order to check whether medical assistance is necessary. Patients carry a small device with them, that in case of a cardiac dysrhythmic event can record the heart beat. The patient can transmit the data via telephone by acoustic coupling, infra-red or BT to the Vitaphone data centre. The products of the company thus connect patients, cost bearers and medical care centres. The patient benefits from an increased quality of life, avoiding emergencies and unnecessary hospitalisation. The system further leads to a better patient consciousness and higher patient security. The solution the company offers consists of a hub, a telemedical service centre, medical equipment and services to connect patients with the call centre and the call centre with medical care centres. The service hub is based in Chemnitz. The hub serves the geographical area of Germany, Austria and Switzerland. It collects data from remotely monitored patients and performs the communication with the medical partners. The rest of the world is served as well from Chemnitz, except for doctors who are located in different areas. Reflecting the federal structure of Germany, the emergency assistance is fragmented, and only accessible to different emergency numbers (being a total of around 350 different emergency numbers associated to 350 different emergency departments). Currently the system tracks 5 patients on the move and abroad when they provide Vitaphone with their travel route, in the future a GPS based system will be combined to the devices. Cardiac dysrhythmia and coronary heart diseases are examples for the use of Vitaphone products. The time between the incidence of a heart failure and the first treatment (a crucial indicator for surviving the heart failure) can be reduced from 225 minutes in ordinary situations to 44 minutes in case of using Vitaphone's service infrastructure – throughout the area which is served by its medical call centre. The full capacity of the Vitaphone system allows following up to 35.000 patients. At present 25.000 patients are served. Prof. Korb explained how Vitaphone enables better results for patients at a significantly lower price than conventional practice-based treatments. The established methods are unable to detect or record heart problems which occur suddenly and infrequently. A recorder as provided by Vitaphone can catch these results immediately while they occur. Another relevant feature of the system is the presentation of educational content e.g. directly through the measurement device or as stand-alone through a dedicated TV-channel. This includes material to raise awareness among patients about their condition and material aimed at health professionals. Insurance companies are seldom interested in clinical studies outcomes and tend to carry out their own studies mainly from a cost-benefit angle. Vitaphone has had to negotiate the inclusion of its system in reimbursement structures with each insurance company separately in Germany (there are many insurance companies in Germany, some of them related to firms Betriebskrankenkasse). Vitaphone was able to negotiate with some of the Betriebskrankenkasse but even so most of the subscribers to the service pay for the device and the service privately. The German "Institut für Gesundheitsökonomie" performed an evaluation study on the effectiveness of the Vitaphone system, with a sample of more than 800 patients. On the basis of the outcome, an insurance company performed its own analysis on a subset of 111 patients in order to have the most critical dataset possible. The findings of the health insurance company corroborated the earlier findings of the health institute, and the Vitaphone system was approved and included for reimbursement. The findings also indicate that acceptance of the service is high, it offers security and mobility to the patients. Costs for participation in the system are relatively modest. In order to convince insurance companies and other parties of the benefits and quality of its approach Vitaphone has invested in setting up a quality infrastructure for the managed care model. It initiated and participated in a Working Group on Telemedicine within the German VDE (Verband der Elektrotechnik, Elektronik and Informationstechnik), contributing to a position paper on quality management of teleservice centres (2002-2005) and producing a Quality Handbook of more than 900 pages (2007) which details the set-up and quality assurance regulations for such a Teleservice centre. Any system fulfilling the requirements of the Handbook will be acknowledged as VDE Certified Management System. Vitaphone is involved in a number of national and international research projects which together offer a broad array of activities Vitaphone is committed to: - EasyCare , dealing with care at home for and Motivation60+ for Sports and activity, two national projects focusing on the consumer market - EMOTIONAAL (diabetes) and AMICA (for patients with COPD- a presentation at http://www.aal-deutschland.de/europa/dokumente/amica_en.pdf ), two international projects focusing on managed care models. 6 Next to these two markets Vitaphone also expects the employer market (reduction of absence due to sick leave) to become an interesting market. The activities of Vitaphone have led to interest by major insurance companies. Vitaphone expects to sign a contract with a large Health Insurance Company in the coming few months. In discussion, the question of how long term dependency on these devices and services is avoided was raised. Prof. Korb explained that patients accept the device and use it. He referred to a study performed by the Berlin University which shows acceptance of the Vitaphone system. Further questions included whether a health technology assessment had been done, whether the data is handed over to the insurance and how data protection was addressed. Mr Quinger explained that even though the data remains with the company and only with the company, the patient exercise all the rights related to their data. 4. Perspectives from Docobo on PHS 4.1 Speaker Mr. Peter Levene is a business development director at Docobo, a UK healthcare solutions provider specialising in remote monitoring products and services, with 14 members of staff (doubling since last year). He spoke primarily as a representative of the company, offering their perspectives on the current state and the future development of the market as well as their own product portfolio. 4.2 Presentation and Discussion Mr. Levene covered a wide variety of topics in his presentation, from the perspective of his company that originally started as an EU funded project and has developed into a successful telehealth care service model. The development process started in 2001 with participation in an EU FP5 RTD programme Doc@Home, followed by participation in REALITY, an EU Quality of Life trial of 78 patients (with a socio-economic focus), and EU eTEN project on Health and eLife. Docobo has also taken part in small-scale RCT trials in 2003 and 2007 on chronic respiratory diseases and is currently participating in the UK projects ‘PEACE’ and ‘PEACE ANYWHERE’ that take a new approach to Personal Care Environments. Docobo's rollout of commercial services started in 2006 with the development of a business case model and its deployment to Primary and Secondary Care Trusts. Docobo has started out with the goal of managing long term condition patients, where the potential both for improving the quality of life of the patients and the costs for healthcare institutions is at its highest. Long term condition patients are the ones with whom the focus is on case management, the patient segment which requires the most active management (see slide #4). Docobo is in the process of broadening the appeal of Telehealth to other patient segments from 2009 According to Mr. Levene, Telehealth brings many challenges through a richness of data that was not previously available. An example that challenges the implementation of best practice is where the management of patients with Hypertension was cited: a study showed that best practice was not as effective as possible in managing patients and did not use all information that it was possible to collect. From this viewpoint, Docobo is of the opinion that the 7 application of Telehealth will provide information that was previously unavailable that could be used to enhance clinical practice. Docobo is addressing two focus areas: 1) filling the gaps in existing systems, 2) modelling (service integration, service pathway, project cost benefits). Mr. Levene said that only a few years ago, there was no policy and therefore no market for these type of services. This has now changed, and the key to service provision is to provide the necessary infrastructure, to be used where it is needed. In other words, the infrastructure should be compatible with whatever service is required. In the case of Docobo, contracting authorities that purchase systems have access to all services and applications current and future without further costs. An annual cost of GBP 545 covers all aspects of service delivery, free telephone calls, technical support, access to the WEB 24/7 and the ability to define clinical packages to suit local needs. Docobo has developed a number of tools to assist authorities in determining their business cases. A typical cost effectiveness model for 20 patients monitored for 12 months identifies a cost for the first year is GBP 22,000, which goes down to GBP 11,000 for the second year because there is no longer a hardware component included (as the equipment has been purchased the first year). Although the doc@HOME system offered by Docobo is the lowest cost for this type of Telehealth system currently available, with higher volumes and a range of configurations, costs are expected to reduce considerably. Mr. Levene estimates that it may take between 3-5 months to get 50 patients fully deployed using a system because so many different people will have to learn how to use the system (community care, social care, staff training, patients themselves). The PARR++ and the combined model model are used to support patient selection, but the results are not always optimal (the PRISM model in use in Wales is reported to have better results). The most important product Docobo has is the Doc@Home, which is a low-cost tool that enables clinicians to remotely monitor and manage patients in their own homes. The Doc@Home database links users to all the available information 24/7, which can be used in patient management with direct cost savings. In Doc@Home, all information is time and date stamped, both qualitative and quantitative data is collected, patient, carer and clinician satisfaction is monitored, the usage and operational information is recorded, and the whole software is totally programmable (=configurable). Mr. Levene also stressed the importance to get patients to self-monitor, otherwise there will be little progress. Currently Doc@Home includes the information from 2250 patients and represents more than three man-years of raw data, which Docobo has considered offering to a university to carry out a data mining project. Mr. Levene mentioned an interesting heart failure study in Barnsley, where the mere use of remote monitoring caused patients to sub-consciously adjust their lifestyles. According to all the evidence Docobo has, patients provide accurate information in surveys and do not attempt to twist reality. One important point made in the presentation is that what we currently have are not national health services but national illness services. In other words, institutions focus on cure and medication, not prevention. For this to change citizens should become more proactive in their personal health management. This process must start with education and over time should become second nature to citizens. The market for telehealth services, in Mr. Levene's view, follows citizen acceptance, because by that point citizens have understood and accepted the need for self-management. 8 The healthcare sector faces many challenges on both the demand and supply sides. On the demand side, key challenges include the need for more and better healthcare, a greater focus on prevention aspects and stability. On the supply side, there is a need for faster access, improved supply, and new approaches. Doc@Home should in Docobo's view help improve all these needs. In addition, Doc@Home enables productivity gains by decreasing the need for additional staff and assets. Mr. Levene discussed at length the problems faced by SMEs in the health industry. There is a bias towards thinking that big is beautiful, with a focus on large-scale programmes and a tendency to favour larger companies. In his view, SMEs should receive substantially more support than they currently do, with an emphasis on increased SME cooperation with the healthcare system and the long-term evolution of services. SMEs are generally more productive than the larger players, but government obstacles and the lack of effective funding streams make their participation difficult. Nevertheless, SMEs should become more involved, above all because large-scale programmes always seem to fail to meet their objectives. Potential reasons for failure may have to do with increased complexity, administrative burden, and related factors. With regard to effectiveness, Mr. Andrew Hamilton mentioned that Continua has done a summary of 72-75 studies of the effectiveness of telehealth. Mr. Levene had an interesting observation of the role of industry alliances. In general, these are populated by larger and capital intensive companies, setting rules for participation which may be prohibitive for smaller organisations (for instance due to relatively high subscription rates). Although beneficial in itself, the promotion of standardisation by such consortia may postpone the development of the telehealth market, and may prohibit market entrance for other parties, as they might have to adhere to standards set by these consortia. This may block innovation and market access. With respect to standards, Mr. Levene stated that from Docobo’s stand point the issue of interoperability was a continuing problem. This could be be resolved by the issue of truly open standards that define protocol agreements for data into and from the doc@HOME system and that this would be sufficient for both Docobo’s hardware and software to be interoperable. This view was however not shared by all participants. Due to demographic changes, ageing of population and rises in healthcare costs, the EU expects health care expenditures to reach 15% of GDP within the next 20 years. However according to some estimates, healthcare costs will go up to 22 to 26% unless something is done. Docobo thinks telehealth is the way to significant cost savings due to the productivity gains enabled by telehealth. In this context, Mr. Levene reiterated his conviction that smallscale systems are much more efficient to deploy and thus result in higher productivity gains. Telehealth should in his view be used to take care of the most common ailments, which take up 70 to 80% of the resources of an average hospital. Anecdotal evidence of productivity gains already achieved include reduced hospital admissions and reduction in the average length of in hospital stay. An example of productivity gains already achieved with telehealth is the Glenfield hospital. Overall, where hospital stays have gone down from 7 - 9 days per patient to 3 days, resulting in a cost reduction from GBP 2,700 GBP to GBP 700 per episode after redefinition of standard costs. However, figures available in the UK are based on historical data, not on actual throughput from hospitals, the results therefore do not impact the allocation of hospital budgets until the episodes of costs are redefined.. Another example is a Randomised Control Trial performed in Portugal on 78 patients with respiratory diseases which shows promising results for quality and cost-effectiveness of the treatment (See slides). 9 Mr. Levene also commented that currently there is no common standard for electronic health records, and asked whatever had happened to the GEHR standards that have not been taken into use. There is an EU project called Calliope going on, but that is an Open eHealth initiative and is not directly related to electronic patient records. On a final note, Mr. Levene also mentioned 'use case analysis' as a useful tool that Docobo uses regularly. This is a decision-tree based analysis tool, which is used to make sure that the solution offered to the patient is the appropriate one. 10