Smart Care – Friuli Venezia Giulia H&S Telemonitoring System An applied case of ICT supported integrated healthcare / social care home care intervention model Pilot Evaluation The SmartCare project is co-funded by the European Commission within the ICT Policy Support Programme of the Competitiveness and Innovation Framework Programme (CIP). Grant agreement no.: 325158 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.
Transcript
Smart Care – Friuli Venezia Giulia
H&S Telemonitoring System
An applied case of ICT supported integrated healthcare / social care home care intervention model
Pilot Evaluation
The SmartCare project is co-funded by the European Commission within the ICT Policy Support Programme of the Competitiveness and Innovation Framework Programme (CIP). Grant agreement no.: 325158
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.
authors:
Matteo ApuzzoKira StellatoDonatella Radini Andrea Di Lenarda
reviewed by:
John Oates
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Table of Contents
Table of Contents pp. 3
1 Introduction pp. 51.1 Purpose of this document pp. 5
1.2 Glossary pp. 5
2 Domain 1: Description of the health problem and characteristics of the ICT solution pp. 72.1 General description of the health and social situation of care recipients pp. 7
2.2 Current management of the health and social situation pp. 8
2.3 Description of the ICT solution supporting integrated care pp. 10
2.4 Technical characteristics of the service pp. 12
2.4.1 Health Care and Social care integrated platform pp. 12
2.4.2 Characteristics of the devices pp. 12
2.4.3 The Hub – Hermes pp. 12
2.5 Requirements for use of the ICT solution pp. 13
2.6 Training pp. 14
2.7 Overview of interactions pp. 15
3 Domain 2 and 3: Safety and clinical effectiveness pp. 213.1 Introduction pp. 21
3.2 Objectives pp. 22
3.3 Methods: Study design pp. 22
3.4 Methods: Setting pp. 23
3.5 Methods: Participants pp. 24
3.6 Methods: Data sources / measurement pp. 24
3.7 Methods: Bias pp. 24
3.8 Methods: Statistical methods pp. 25
3.9 Results: Participants pp. 26
3.10 Results: Descriptive data pp. 27
3.11 Main results (outcomes) pp. 28
3.12 Discussion pp. 31
3.12.1 Key results pp. 31
3.12.2 Limitations pp. 31
3.12.3 Generalizability pp. 31
4 Domain 4: Patient perspectives pp. 334.1 Methods pp. 33
4.2 Patient Activation Measure (PAM) pp. 33
4.2.1 Estimation of subscales pp. 33
4.2.2 Presentation of subscale results pp. 33
4.2.3 Interpretation and discussion of findings pp. 34
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4.3 eCare Client Impact Survey (eCCIS) pp. 34
4.4 WHOQOL - BREF pp. 35
4.5 Process evaluation pp. 35
4.5.1 Individual care recipient experiences - Round 1 pp. 35
4.5.2 Individual care recipient experiences - Round 2 pp. 36
4.5.3 Summary pp. 36
5 Domain 5: Economic aspects pp. 37
6 Domain 6: Organisational aspects pp. 396.1 Structure pp. 39
6.1.1 Communication pp. 39
6.1.2 Service integration aspects pp. 39
6.2 Process pp. 40
6.2.1 Work flow and/or care pathways pp. 40
6.2.2 Usual Care pp. 41
6.2.3 SmartCare revised care pp. 42
6.2.4 Benefits of ICT supported integrated care pp. 44
6.2.5 Staff and training pp. 44
6.3 Culture pp. 44
6.3.1 Individual professional experiences - Round 1 experiences pp. 44
6.3.2 Individual professional experiences - Round 2 experiences pp. 45
6.3.3 Summary pp. 45
7 Domain 7: Social, ethical and legal aspects pp. 477.1 Ethical issues pp. 47
7.2 Legal issues pp. 48
7.3 Social issues pp. 48
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1 Introduction
1.1 Purpose of this document
This document reports on the detailed outcomes and final evaluation of the pilot in Friuli Venezia Giulia.
1.2 Glossary
BADL Basic Activities of Daily LivingCOPD Chronic Obstructive Pulmonary DiseaseCR Care RecipienteCCIS eCare Client Impact SurveyEHR Electronic Health RecordGP General PractitionerICT Information & Communication TechnologyPAM Patient Activation MeasurePHR Personal Health RecordSCP Social Care Provider
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2 Domain 1: Description of the health problem and characteristics of the ICT solution
2.1 General description of the health and social situation of care recipients
Regione Autonoma Friuli Venezia Giulia (FVG – capital city Trieste) has a land area of 7,858km2, equivalent to 2.6% of the Italian territory. The population recorded at 31st December 2009 (SISTAN - National Statistical System) was 1,237,050 for a population density of 157.4 people per km2. The region, which has primary responsibility in matters of local institutions regulation, left the National Health Fund in 1997. It is divided into 218 municipalities and four provinces. The four provincial capitals are Trieste, Udine, Gorizia and Pordenone. According to official population ISTAT statistics, updated 31st December 2010, in FVG there are 155 Municipalities with up to 5.000 inhabitants (71,1%), 40 Municipalities between 5.001 and 10.000 inhabitants (18,35%), or 195 Municipalities with over 10.000 inhabitants (89,45%).
In Friuli Venezia Giulia, in 2008, 11.9% of citizens were between 65 and 74 years of age, the national average being 10.3%; while people over 75 accounted for 11.3% of the regional population, against an Italian average of 9.8%. The percentage of people over 65 years of age living on their own is 15.9% for men (Italian average 14.5%), and 36% for women (Italian average 37.5%), accounting for 27.8% of the total number of people within that age range, against a national average of 27.8%. The rate of elderly people living on their own, over the total population value within the same age range, is a useful indicator that is taken into account when planning local socio-medical services. This is because the elderly who live on their own are more exposed to the risk of social exclusion and, due to their age, to serious and disabling diseases, which may result in confinement and a greater need for socio-medical assistance during their daily life routines.
In Friuli Venezia Giulia, the (general) mortality rate over one year of age is 92 per 10,000 inhabitants (2006-2007), while the national average is 89.8. As far as certain mortality causes are concerned (2006-2007), FVG show a death rate due to circulatory system diseases of 29.7 per 10,000 (national average 31.3 per 10,000) and a can-cer mortality rate of 34.1 per 10,000 (national average 31.1). Within the female population, mortality rate due to circulatory system diseases is 19.6 per 10,000 (national average 21.5 per 10,000), while the tumour-related death rate is 19.4 per 10,000 (national average 16.6).
Mortality rate due to heart ischemic diseases: in 2009, FVG shows a 15.87 per 10,000 male death rate, against a national average of 15.87 per 10,000. Female death rate, due to similar disease, accounts for 9.54 per 10,000, against a national average of 8.56. As far as the standardised hospital discharge rate of haemorrhagic stroke is concerned, an alarming increasing female trend was reported between 2007 (58.3 rate) and 2008 (63.0 rate for both genders). FVG reports the lowest hospitalisation rates in Italy.
Since the 90s, FVG has developed a coordinated healthcare / social care sector with some pilot implementations of ICT solutions. However, the system is still fragmented, and shows room for further integration both in terms of ICT and inter/intra-team communication. The public FVG health service is divided into five Health Authorities, two -university hospital bodies, and three research / rehabilitation bodies. 20 Districts act as reference centres for all the services provided by the NHS Authority; they ensure integration between health and social services, and coordination of social workers as well as private and volunteer organisations. Social services are provided by Municipalities, and work in close contact with healthcare providers within Districts. GPs and most specialists are an integral part of each District. A spoke hospital may act as the intermediate health reference point of one
District. Three hub hospitals have been identified in the region: Ospedale Maggiore, Ospedale Cattinara in Trieste; S.ta Maria della Misericordia in Udine; and S.ta Maria degli Angeli in Pordenone.
Within the district services, a district door (one-access point) has been established to guarantee access to welfare facilities. This entrance point is managed by healthcare and social care staff. Home health services are provided
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by nurses and rehabilitation therapists in collaboration with GPs, social workers, home assistants, physiotherapists, specialised physicians, volunteers, and other medical and social operators. District medical residential facilities (RSA) for intermediate care provide assistance for the rehabilitation of hospitalised patients suffering from serious multiple pathologies (e.g. orthopaedic, neurological, pneumological, cardiovascular pathologies, etc.) as well as for patients with stable, or temporarily major, social problems requiring ‘relief’ for family members and/or patients with prevailing end-of-life issues, i.e. terminally ill patients. A territorial cardiology service attends to patients discharged from different hospital structures (e.g. ER, cardiology, 118, etc.). Social services (managed by Municipalities) carry out several interventions to provide support to citizens who may be particularly vulnerable because of their physical, mental, or socio-economic conditions; they also activate measures to ensure domiciliary care for the sick and the elderly.
In 2014, FVG Region approved Law N. 17 which reorganised the regional healthcare system with a particular focus on prevention and “reduction of the preventable burden of morbidity, mortality, and disability for non-communicable diseases”, which include cardiovascular disease, diabetes, cancer, and COPD.
Despite the good level of health and social care integration described above, new social challenges lie ahead for the region’s citizens. In fact, while the Italian family and social structure has thus far acted as a social ‘buffer’ with family members and/or neighbors supporting the person in need, epidemiological, economic, cultural and social changes are undermining the solidity of this spontaneous social structure. Given the rising needs of the growing elderly popu-lation, the burden of non-communicable diseases, and the demands for better integration and communication among formal and informal stakeholders, SmartCare in FVG has been devised to provide better ICT-supported integration of health and social care services, and a more active involvement of care recipients, family members and third sector. Through the integrated platform and the home devices used to monitor clinical and health conditions, care recipient’s status will be updated in real time, thus allowing better handling of health / social deterioration to prevent hospital admissions. The idea underlying the provision of ICT-based support is to enhance person centered care within a be-ehive approach, where each person plays a relevant and unique role within their role (e.g. care recipient, caregiver, formal and informal carers, etc.) and their abilities, and the exchange of information flows smoothly and in real time, while silos of care work synergistically and more effectively to support care recipient’s health and social care needs.
2.2 Current management of the health and social situation
In FVG, the Healthcare Agency Districts were created in 1996 in order to bring healthcare responses into more direct contact with service users. The District intervenes directly in the community, complementing and integrating hospital services. It guarantees unified, long-term responses to the local population’s healthcare and social-healthcare needs, in collaboration with local municipal services.
The Districts deliver services not only in out-patient facilities, but also in the home and wherever users live and work, and tries to provide comprehensive responses to user needs, with a special attention to special problems. Services offered include medical analyses and exams, consultations with specialists, rehabilitation and administrative acts. Personalised information can be received, and appointments for other healthcare services can also be made in the Districts. The District is not simply an out-patient or poly-outpatient service, or worse, a “waiting room” for exams or therapies. Instead, District operators provide comprehensive care for users, creating the most appropriate responses to individual needs and assisting users during their healthcare itineraries. Healthcare services can be delivered wi-thin District facilities or at home, can be exclusively medical or also involve integrated social-healthcare interventions, and include evaluations by different professional figures. In complex cases with very limited patient autonomy, the operators (nurses, District physicians and specialists: urologists, cardiologist, surgeons, oculists, dentists, etc.) go to the person’s home in order to provide the most appropriate care. Home care is not limited to medical interventions but in case of need (such as when patients live alone) can also involve neighbours, Municipal services, volunteers, the local parish, family members, etc. in order to provide forms of assistance and care.
The District staff include physicians, psychologists, nurses, social workers, obstetricians physical and speech the-rapists, healthcare technicians and administrative personnel. These operators work together as a team, while also collaborating and interfacing with other sectors / agencies: hospitals, volunteers, Municipal services, etc. GPs re-main the primary referent due to their first-hand knowledge of individual patients. The GP determines which analyses
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and examinations are required, and then refers the patient to the District for the most appropriate diagnostic and therapeutic responses.
Primary care and home care: Provides out-patient medical services and home care (including in nursing homes or other residences) to persons of all ages with personalised healthcare plans. The service operates 12 hrs daily, 7 days a week, providing care for patients after their release from hospital to ensure therapeutic continuity, and gua-ranteeing medical, nursing and rehabilitative care in the user’s home. The service is accessed directly after referral by a physician, though the referral can also be made after the patient’s initial contact with the District. Home care can also be requested by telephone.
Elderly persons: The service is accessed directly and provides social-healthcare, out- patient and home care services for the elderly. It provides assistance for social problems, facilitates administrative procedures related to invalidity, and provides evaluations for hospitalisation in a healthcare residence, nursing home or for a care subsidy. The service also provides care for persons with complex problems, activates the tele-help services, and collaborates with the “Amalia” project.
Specialised medicine: Provides specialised medical appointments and services, and nursing, out-patient and home care; organises diagnostic-therapeutic processes, especially for more complex cases; manages the out-patient service for substance abuse, together with GPs. It is accessed through the Appointment Centre with physician referral (except for stomatological and gynaecological needs) or, for special needs, by contacting the District directly during working hours.
Rehabilitation: Delivers rehabilitation services for adults, both out-patient and at home; exams with a physiatrist; multi-disciplinary evaluations for severe disabilities; assistance for prosthetics; care for patients with temporary or permanent disabilities which also foresees training and assistance to family members. Accessed with medical pre-scription, except for information / assistance for prosthetics, which can be requested directly during District hours.
Out-patient nursing healthcare is provided by the Domiciliary Nursing Service (SID - Servizio Infermieristico Domi-ciliare); it is made up of nurses and support staff. It also involves rehabilitation specialists and physicians (either independent or operating within the National Health Service) according to the different time frame and planning of individual care which may be organised through the Individualised Care Plan (PAI - Piano Assistenziale Individuale) for users with complex health needs, or through autonomous low complexity interventions (assessments, counselling, tests, sutures, medications and injections) which may take place over a period of time, without the presence of a specific care plan.
The service can be requested by anyone, either in his/her own name, or on behalf of another user. Should the service be requested for nurse interventions only, no request has to be formally issued by user’s GP; however, it is necessary to communicate with user’s GP about objectives and outcomes of intervention.
The individualized care plan (PAI) has been implemented to keep the citizen in his/her home environment, limiting hospital access to acute episodes only. This may contribute to preventing complications and supporting the person and his/her caregivers during the most advanced / final stages of the disease. This holistic approach ensures well-coordinated and consistent interventions which may act as a valid alternative to hospital care. This approach allows for individualised, person-centred, integrated care, in both at home settings and in intermediate care facilities. As defined by DPCM 29.11.2001, under ‘definition of essential care levels’, this care approach is free of charge for the end user, as is hospital care. Hence, given the high organisational cost of such interventions, it is mandatory to ensure the utmost effectiveness and efficiency of the service.
The care process is structured in such a way to provide actual health / social care as well as education and pro-motion of self-help modalities, with a focus on the person and his/her social network. The goal is to activate a rela-tion-based as well as a health and social-based network of care and support. The interventions for the promotion of self-management and empowerment aim to promote individual autonomy and self-efficacy, and prevent any inappro-priate hospitalisation and subsequent loss of autonomy and personal well-being. Within such a dynamic process, the user’s case-manager (usually a nurse, but may also be a social worker) will start an individualised care plan which
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will be structured together with the whole care team (end user, caregivers, GP, social workers, formal and informal carers, including Third Sector) with the support of telecare and telemonitoring services.
The above plan is drafted on the basis of validated multidimensional instruments. Should the end user require social interventions as well, a complex plan will then be drafted allowing for integrated multidisciplinary and multi-dimen-sional care. This kind of domiciliary health / social care is then defined an ‘Integrated care intervention’. The end user’s case manager thus becomes the ‘family’ nurse, acting as a link between the end user and his/her family and the rest of the team.
The family case manager:• Assesses the care recipient’s healthcare and social care needs through structured and semi-structured interviews
administered to the user and his/her caregivers. The assessment is also shared with the user’s GP and other professionals. Such an assessment is based upon the user’s clinical evaluation (patient’s chart), observation of signs and symptoms, behaviour, home environment, and evaluation sheets (e.g. Norton Stotts for risk evaluation, ValGraf questionnaire, etc.).
• Draws up an individualised care plan which is subsequently shared with the user, his/her GP, and other profes-sionals (if included in the care plan). This plan clearly defines end user’s health / social care needs; it defines the nurse’s plan, the overall health and social care goals, and the actions to be carried out in order to meet such goals. It also includes physicians’ prescriptions, structuring of interventions (including specification of possible he-althcare and/or biomedical devices), length of interventions, timing and schedule of assessments, and expected outcomes.
The care intervention usually uses the Home Care Chart that acts as a shared document. It records, if required, the formal request for activation of such a plan by the user’s GP, the health care / social care plan for interventions car-ried out by professionals, and formal / informal carers and any other document which may be used for the planning of the integrated care plan.
2.3 Description of the ICT solution supporting integrated care
The following integrated ICT-based solution has been devised to collect and integrate clinical and social data in the most efficient and least-invasive way.
The H&S Health Station Hermes 2.0 is organised as follows:
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HEALTH PLATFORM
The Health Station Hermes 2.0 acts as an interface between medical devices and central storage unit database whi-ch collects data through HUB Hermes data collector. A configuration module allows for end-user’s direct association to specific devices and to their care team.
KITS
KIT’s structure can be adjusted and tailor-made to meet end-user’s needs according to care team shared plan. Kits collect clinical and environmental information and transmit acquired data to call-center without requiring any phone contact to be activated by the end-user to the operator. The system has high level of data storage, and permits that no data can be lost: each device has its own memory and stores data until they are transmitted to and recorded by the HUB; the HUB works in the same way towards the central storage.
Each KIT is structured as follows:
HUB – HERMES, a data collector to be installed at the end-user’s home. HUB- HERMES can dialog with medical devices through Bluetooth, USB, and Ethernet. Besides acting as an at- home Health Station, it can also connect and share information through 3G, ADSL, PSTN channels also allowing for WiFi connection. All communications (e.g. alerts) are visually and acoustically signaled and can be acknowledged through an easy-to-use pushbutton. Likewise, al Medical Device and/or sensors’ information are collected by HUB-HERMES both in silent mode or upon end-user’s request. Medical devices being part of the KIT are as follows:• ELECTRONIC BLOOD PRESSURE DEVICE – it measures systolic, diastolic pressure and pulse frequency through
wireless Bluetooth technology. A 16 mm characters liquid crystal display allows for high-quality visual readings.• PULSE OXYMETER with wireless Bluetooth technology for accurate and user-friendly recordings.• ONE-LEAD PORTABEL ELECTROCARDIOGRAM (ECG) – it allows for recordings of symptomatic and asymptoma-
tic events, suitable for continuous monitoring of patients suffering from heart failure. In addition, the Pulse Sensor may monitor heart rate, respiratory rate while providing an algorithm to assess relevant activity levels. Messages are then transmitted by and to the server according to settings predefined by healthcare professionals (both in Streaming Mode and in Monitoring Mode).
• TABLET – it allows access to the end-user’s agenda and relevant data, and activates video-conferencing mode (according to predefined access levels).
• FORA BLUETOOTH SCALE - To perform Body Impedance Assessment through analysis of FM, FFM, and TBW. This kind of monitoring is very important in patients with heart failure.
• FOR A DM20 BLUETOOTH GLUCOSE METER - to measure blood glycaemia.• SMART WALK - certified medical device to measure amount of movement during the 6-minute walking test or du-
ring the day, measuring accelerations and, subsequently, falls. Three-dimensional accelerometer ideal for elderly patients.
• HELP-ME - certified medical device to send an alarm requesting help through sound and light signals. After a predefined amount of time, call center is activated.
The Health Platform has been devised to allow for effective, not invasive continuous monitoring of end-user’s para-meters and for efficient and effective integrated exchange of clinical, social, and environmental information among stakeholders. Each end-user’s clinical and social chart will contain both clinical and social information supplemented by reminders (e.g. pill reminders), questionnaires to be filled either by the end-user or by formal/informal carers (e.g. Valgraf, WHO-QOL-Bref), contact information, alarms and measurements.
All data are protected in compliance with the existing law, both at national and European levels. Data encryption is made possible through Internet protocols based on HTTPS system. Access to the system is regulated through userna-me and password (password rules as for personal sensitive data). The system has been planned and constructed to ensure person-centered interventions respecting end-user’s privacy while at the same time promoting interconnecte-dness, operability, and integration of care plans to ensure sustainable person and people-centered healthcare and social care interventions.
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2.4.1 Health Care and Social care integrated platform
The Health Platform was developed by H&S qualità nel software as a Class IIa Medical Device software platform of-fering and managing all the activities and processes of home health telemonitoring. The Health Platform provides an interface between the end user’s home’s devices and the central database storing the information acquired through a concentrator called “HUB Hermes”. Its software program sends all data to the central database through standard Web-Services based on secure HTTPS protocols, and has a configuration that allows setting the different medical devices according to the end user’s specific needs. In addition, it can identify and connect with the end user’s phy-sicians and healthcare institutions. Health Platform is a 3-tier web platform with a presentation layer accessible to most browsers, technologically advanced middleware that improves system scalability and resistance to failure, and a clustered back-end database handling failures and load balancing of the transaction processing.
Kits delivered to the end users are prepared according to the protocol of medical treatments and monitoring schedu-les established by their healthcare and social service institutions. The structure of the kit varies. Some elements are fixed, others depend on the kind of monitoring required.
2.4.2 Characteristics of the devices
The devices of the kit have been chosen to grant high quality and high manageability tools to both patients and caregivers. The elements composing the kit will be selected according to the end users’ different pathologies; all information concerning them will be reported in the clinical protocol chart.
Kits for collecting end users’ clinical and environmental data are technologically advanced, and are designed to transmit data remotely, with no need for phone contacts between end users and healthcare professionals.
The composition of each kit depends on the protocol established by the end user’s medical staff. The next section describes technical and functional characteristics of all available devices.
2.4.3 The Hub – Hermes
The main component of the kit is a home HUB called “Hermes”. It is a computerised data concentrator purposely designed with the aim of allowing the end user to communicate with the central healthcare system in a user-friendly way, minimising as much as possible any possible discomfort.
The home HUB grants:• bidirectional interaction with the end user through visual and acoustic signals, messages, memos, reminders and
personalised questionnaires;• collection and recording of the end user’s clinical and environmental data from various measurement instruments;• automatic transmission of data to the central healthcare system;• a 4x20 character LCD display, six intuitive buttons, and four LED status indicators;• connectivity to 3G portal, Ethernet and PSTN;• internal connectivity to Bluetooth, WIFI, USB, Z-Wave, in-home Wi-Fi connection through which the end user can
reach the portal using a tablet Android for video conferencing with the hospital staff.
The HUB supports home monitoring since its technology establishes a continuous communication flow between the end user and his/her physicians / healthcare and social care providers by sending them all the clinical and environ-mental information they need via Bluetooth, USB, or Ethernet.
In particular, the HUB transmits data received from the following medical or environmental devices to the central database:• A&D blood pressure monitor.• Nonin Onyx II 9560 Pulse Oximeter.• 1-lead ECG.• Tablet.
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• Fora weight scale.• Fora DM20 blood glucose monitor.• Smart Walker detecting the patient’s movements and sending an emergency signal if a fall occurs.• Help ME button for the patient’s requests of assistance.• Various Z-Wave protocol environment sensors.
The Hub Hermes provides to the patients a home Health Station allowing various medical and non-medical devices to intercommunicate by means of wired or wireless networks and to connect to the outside world via:1. 3G.2. ADSL.3. PSTN.
Besides that, it offers WiFi home connectivity as well. In this way, any end-user device will be able to connect and communicate in a controlled mode with the Health Pla-tform portal through this WiFi connectivity system.
All home medical devices and sensors connected to the Hub communicate to the portal either automatically or on end user’s request, depending on the chosen configuration.
H&S Quality nel software was founded in Piacenza in 1989 by a group of professionals with backgrounds in highly qualified spheres of ICT. The company has developed experience in the public sector, finance, telecommunication, and health technology. Over the last ten years, H&S has been developing different healthcare solutions thanks to national and international partnerships (Airliquide, Merck). Applications for home healthcare and hospital care, as well as applications for internal use, were realised in Italy, Germany and the UK. Services, software and hardware for telemedicine have been developed for chronic patients (diabetes, COPD, CHF, asthma), post-acute patients (heart attack, stroke, etc.), patients of hospital ward (e.g. oncology) and patients with oxygen and/or home equipment (fans for oxygen therapy, nutritional pumps, etc.). Experience has been developed for both integrated home care as-sistance and hospital discharge. Given the ICT-integrated home care existing knowledge, the SmartCare ICT-solution was not built from scratch, but was personalised in order to integrate the specific project’s needs (e.g. personalised alarm thresholds) and requirements to better serve the multidisciplinary, all-encompassing integrated-care goal.
Integration with other existing ICT-platforms (e.g. INSIEL, GPs) was not possible at this time because of the lengthy bureaucratic / technical process which would have prevented speedy deployment of services. However, interopera-bility was ensured in domiciliary care with the existing De La Roche device to monitor prothrombine time.
FVG previously was a participant in the Dreaming project, a teleassistance at home project for the elderly which included health monitoring services, environmental monitoring, and alarm management.
SmartCare platform was built as an independent project with no technical relation to the previous platform. However, the experience drawn from this previous project allowed FVG to better identify specific integrated health and social care needs and requirements, so as to enhance the ability of the platform to meet the multi-professional and multi- professional needs of formal and informal stakeholders.
2.5 Requirements for use of the ICT solution
The Health Platform has been designed for home monitoring, tele control and environmental monitoring of patients with different pathologies and different social needs so as to improve their quality of life both in terms of health care and management. The activation of the home-based platform takes place within 24 hours from end user’s short- term enrolment and within 48 hours of long-term enrolment. No special premises are required. Devices are small and non-intrusive, nor do they require invasive interventions (e.g. no holes have to be drilled in the care recipient’s home). GPRS mobile connection is used with no burden on the care recipient. Should this connection stop working for any given reason, a PSTN connection will activate a toll-free number. The home station connects to the data-centre via web and does not require any download to PC.
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The platform has a multi-faceted configuration and is operated by two categories of subjects:• Healthcare / social care providers, who have access to the system according to their specific roles.• End user’s. Their demographic and anamnestic data include:• General demographic data.• Contacts of family members and informal caregivers.• Clinical condition, health and social problems.• Existing treatment programme (for planning contacts with operators and data collection).• Clinical and environmental measurements collected at home.• History of medical diagnoses, medical and social communications.• Description of goals and potential threats to the given medical and social protocol.• Description of alarms generated by the patient and alarms generated by the system.• Permission for questionnaires evaluating the end user’s experience, such as the Val.Graf.• Calendar of all the operations done to and planned for the end user.• Description of the devices provided.• Description of the devices for communicating with other users of the system.
No particular equipment is needed to use the service, which is made up of:• Clinical and environmental sensors equipped with wireless connections and battery powered supplies to minimise
the impact of installation of the home devices.• Devices to improve communication between stakeholders.• Mobile localisers and alert systems.• Service ICT-based platform.• ICT-based platform access and usage devices for access by all stakeholders either at the user’s home, or in remote
locations.
Access to the platform is arranged according to different access profiles (e.g. district team, social carer, GP, specia-list, administrator, caregiver, end user, etc.).
In the SmartCare Project, an important role is played by the Help-Desk / Call Centre (COMES). COMES staff ensure technical and healthcare support to end users and their caregivers. A national toll-free number 800.109.300 allows users and caregivers to call and signal support needs at no cost. This same toll-free number may be used to send calls from Hub to data centre should there be any problem related to coverage or lack of ADSL connection. Should this be the case, the only possible connection would be via PSTN (home phone) by calling the national toll-free number, at no additional cost.
2.6 Training
A great focus has been given to training of formal / informal stakeholders, both at the beginning of the service and throughout the service cycle, through initial evaluation of needs, feedback, reinforcements and 24/7 help desk availability.
Information and training activities are provided to formal and informal stakeholders, supplemented by all relevant documentation. The information / training programme includes basic principles concerning: the functioning of the different devices with practical demonstration of device usage (on/off procedures); description of main alarms (if applicable) and relevant alarm protocols (according to indications provided by the Care Team); cleaning of devices and ordinary maintenance instructions; contact instructions in case of alerts.
Depending on different needs, training is provided according to the following modalities: face-to-face (for health and social care operators); one-to-one (for care recipients and caregivers); and experiential for all stakeholders. Docu-mentation is provided including list of devices, serial numbers, user manuals, and all other relevant documentation. Web- based tutorials will be activated to support stakeholders’ training needs. Toll-free help- desk number is available 24/7 to respond to questions on platform / device use.
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2.7 Overview of interactions
The SmartCare approach, in FVG, is based on a full integration of ICT-supported communication between healthcare and social care providers and with care recipients, caregivers, and third sector.
Table 1: Indicate the interaction between all actors, within and between sectors (usual care)
Health servicesUsual care
Health services
Medium:Primary and secondary continuity of care in place, through hospital care, intermediate care, home care, office visits. GPs and specialists have inte-ractions. There are some shared / agreed care pathways and guidelines for main diseases. Good usual care integrated pathways within frag-mented workflows. ICT solutions not available.
Social services
Low:Some steps of pathways are integrated (e.g. multidisciplinary asses-sment). Care recipients at high level of complexity managed in a good cooperation / integration, despite pathways deve-loped within fragmented workflows. ICT tools not in use.
Third sector
Low:Third sector may be part of the provision of care, not equally in all areas of the Region; if such a need arises, is part of the per-sonalised care program. Close relationship with the organisation within the Health Districts.However, third sector may play only a subordinate, side role, with no real integration within the care process.
Other providers
Low:Fragmented and non- homogeneous communication flow. Private home services paid out of pocket often not integrated with institutional offerings.
Person- care recipient
Medium:Integration of services is good, but CR often plays very passive role.Self-care of CR cannot be closely monitored.
Family – entourage
Medium: May attend Districts’meetings, butmost of their contacts are with primary health care nurses; communication is fragmented.
16
D8.4 Annex 4 FVG-ASS1 detailed outcomes
New care
Social servicesUsual care
Health servicesHigh:Shared information of clinical relevance improves joint care of GPs and spe-cialists. The telemonitoring tool allows the home care health services to better monitor the status of the patient. Workflows defined and ICT solutions fully integrated.Integration with other platforms (e.g. regional, GPs) still missing.
Low:Though usual care in FVG means integrated care, due to the lack of an ICT common platform, commu-nication is fragmented.
Social servicesMedium:The telemonitoring tool allows the homecare services to better monitor the status of the patient. Workflows defined and ICT solutions fully integrated. Integration with other platforms (e.g. Municipality) still missing.
High:Good sharing of infor-mation. A recent ad hoc electronic personal record (specific for social services) in use.
Third sectorHigh:Third sector becomes part of the provision of ICT-supported care when such a need arises, having access to the platform. Closer relationship with the organisation within the Health Districts.
Medium:Formal agreements in place for the third sector to be part of the provision of care.
Other providersMedium:The telemonitoring tool allows the home care health services to better monitor the status of the patient. Workflows defined and ICT solutions fully integrated.Integration with other platforms (e.g. regional, GPs) still missing.
Medium:Within the field of social services’ provision.
Person- care recipientHigh:Direct, pro-active involvement more possible through access to platform. Improved support for self-care and adherence through automated pill- reminders, phone calls, and electronic pill box.
Medium: Fairly good integration of services.Fragmented communication.
Family – entourageHigh:Direct, pro-active involvement possible through access to platform.
High:Good services but fragmen-ted communication due to the lack of ICT instruments.
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D8.4 Annex 4 FVG-ASS1 detailed outcomes
New care
Third sectorUsual care
Health servicesMedium:The telemonitoring tool allows the home care social services to better monitor the status of the patient. Workflows defined and ICT solutions fully integrated.Integration with other platforms (e.g.Municipality, regional, GPs) still missing.Better and faster plan of services can ensue.
Low:Formal agreements in place for the third sector to be part of the provision of care. Still fragmented communication.
Social servicesNo changes.
Low:Close relationship with the organisation, but fragmented communication.
Third sectorMedium:ICT platform allows for faster and better communication.
N/A
Other providersNo changes.
No interaction.
Person- care recipientHigh:The telemonitoring tool allows the home care social services to better monitor the status of the patient. E.g.Waistband for falls alert is a very useful tool to moni-tor status and plan specific interventions ahead of time.
Medium:Depends on individual relations and fragmented communication.Different areas in FVG have different levels of involvement of third sector volunteers.
Family – entourageNo changes.
Medium: Only when needed and available.
18
D8.4 Annex 4 FVG-ASS1 detailed outcomes
New care
Other providersUsual care
New carePerson- care recipientUsual care
Health servicesMedium:Direct involvement in integrated care through opportunity to help CR take measurements in case of need. Possibility to write notes and information on the platform regarding emerging needs, etc.
Low: fragmented communicationNo changes
High:Good services. However, the CR plays a more passive role, being the object and not the subject of care. Services are excellent, but self- care cannot be monitored.
Social servicesMedium:Can provide information which may be useful for the social care.
None
No changes
Low:The CR plays a passive role, being the object and not the subject of care.
Third sectorn/a
None
No changes
LowInteraction is low and fragmented.
Other providersNo interaction
None
No changes
LowContacts are usually mediated by healthcare / social care.
Person- care recipientHigh:Direct involvement in integrated care through opportunity to help CR take measurements in case of need.Possibility to write notes and information on the platform regarding emerging needs, etc., and help CR do the same.
None
No changes
n/a
Family – entourageHigh:Direct involvement in integrated care through opportunity to help CR take measurements in case of need.Possibility to write notes and information on the pla-tform regarding emerging needs, etc., and help CR and family to do the same.
None
No changes
n/a
19
D8.4 Annex 4 FVG-ASS1 detailed outcomes
New care
Family–entourageUsual care
New care
Health servicesHigh:CR is directly involved in self-care activities (e.g. BP, glucose, weight) and can directly write on the pla-tform, use it as a reminder for his meds, organise his calendar, write a journal, etc.
High:Caregiver may attend UVD District meetings but all information exchange is fragmented, requires time and effort.High:Added value: Family may be involved in the care process and receive information from the ICT platform as well as writing notes and messages.
Social servicesMedium:Better control of environ-mental indicators, e.g. tem-perature, falls, etc., allows for more timely activation of services.
High:Caregiver may attend UVD District meetings but all information exchange is fragmented, requires time and effort.High:Added value: Easier communication and easier planning of visits through the platform calendar / schedule.
Third sectorMedium:Clearer role of third sector, important especially for CRs who have no family ties.
Low:Only when needed, not so clear how to ask for their intervention. Fragmentation of knowledge.
High:If and when needed, easier to communicate and get feedback.Planning of home visits can be facilitated through the platform calendar.
Other providersNo changes.
n/a
No changes.
Person- care recipientn/a
n/a
Support for medication adherence through reminders and electronic pill box make it easier on the family.
Family – entourageHigh:Easier communication with family who can be part of the integrated platform.
n/a
More than one family member can participate in the integrated flow of communication.
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21
3 Domain 2 and 3: Safety and clinical effectiveness
3.1 Introduction
Answered in Domain 1.
The study was planned to ensure active participation of all formal and informal stakeholders involved in an integrated healthcare / social care home care intervention (end users, family members, formal and informal caregivers, case managers, nurses, social care workers, GPs, district physicians, specialists if needed). The goal was the provision of integrated, ICT-supported real-time communication, enhanced by the active involvement of a dedicated Call Centre monitoring system. The formal and informal stakeholders who play an important synergic role in FVG are as follows:• Care recipients: >50 with one or more chronic condition (HF, diabetes mellitus, COPD) and social needs. They
are the main users and beneficiaries of the service. They must be able to connect and communicate at any given time (either directly or through their caregiver) with their case manager, or any equally relevant, appointed pro-fessional.
• Care recipient’s family members: they play an essential supporting role by monitoring parameters and meeting their healthcare and social care needs in real time and to the extent of scope of their abilities. They have to be allowed to communicate at any given time with the end user’s case manager, or appointed person. They act as end user’s caregivers.
• Caregivers: they play a fundamental role by helping elderly users to measure those parameters which need to be monitored. At any given time, they have to be allowed to communicate with healthcare / social care professio-nals. Often, such a role is played by the end user’s family members.
• Informal caregivers: these are volunteers who may either systematically or from time to time play a supportive role in the end user’s care process.
• Case Manager: plays an active monitoring and coordination role of the whole end user’s cure and care process. Often, such a role is played by a district nurse, but it may be played by a physician (District / GP), or by a social worker. The functions related to such a role may be carried out either in the district or at the end user’s home.
• Physicians: may access the system to provide decision-making support during the course of the disease. They may signal through the system any change in conditions that require intervention. GPs play a pivotal role in the end user’s clinical management, and they may act as case managers. District physicians may play a clinical support and coordination role. One or more specialists (cardiologist, diabetologist, pneumologist) may be called on to be part of the care team in complex cases.
• Nurses: They are at the forefront of healthcare interventions. Their goal is to meet end user’s care needs through domiciliary interventions. A nurse may be appointed as end user’s case manager.
• Social workers: they have to provide real time response to the needs signalled by end users. A social worker may be appointed as end user’s case manager.
• Staff from the Monitoring and Support Centre (COMES - Centro Operativo di Monitoraggio e Supporto): they are in close constant contact with all the stakeholders and play a role in randomisation process, setting up of devices at end user’s home, alarm protocols, training, and providing remote support to all the stakeholders involved in the integrated care.
Every actor from the Care Team may receive communications from COMES according to previously agreed proto-cols (by phone, text message, mail) depending on the nature of the communication (information, alarm, etc.), the level of urgency, and the stakeholder’s role. Through SmartCare portal, every actor from the Care Team may be updated in real time on the user’s state of health and general conditions. Access will be granted through personal password according to predefined access levels.
Safety as well as security issues have been thoroughly considered in the planning of the service, and all appropriate measures have been taken to account for accuracy of information, malfunctioning of equipment, transmission of data over secure lines, protection of care recipient’s confidentiality and right to privacy. Every evening, data are uploaded onto a safe disk and placed in a protected storage area.
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3.2 Objectives
Answered in Domain 1.
This study aims to provide effective, sustainable, ICT-based home integrated care to complex, fragile, elderly end users suffering a chronic disease or in post-acute care (heart failure, diabetes, COPD), requiring intensive monito-ring and presenting one or more social needs. The ultimate goal is the activation of a systematic implementation of ICT-based integrated care programmes in FVG with a smoother communication flow between all formal / informal stakeholders, to empower care recipients, and improve their self-care abilities. SmartCare project in FVG also wants to achieve a number of scientific and organisational goals, to analyse the impact on end users resulting from the implementation of integrated, ICT-based healthcare and social care interventions, in accordance with MAST model (Kidholm et al. 2012), notably assessing the following: difference in number of hospitalisations during study and rele-vant length of stay; difference in number of admissions to intermediate care facilities or nursing homes, and relevant length of stay; difference in number of planned / unplanned contacts with healthcare / social care professionals, as well as other informal carers (family members, Third Sector, etc.); difference in end users’ empowerment; difference in costs; difference in organisational aspects as a consequence of ICT-based Integrated from an organisational point of view.
3.3 Methods: Study design
The SmartCare project in FVG has been defined as a cohort randomised study with 1:1 allocation, planned to enrol 200 patients (100 in the intervention group, 100 in the control group). Care recipients have to be >50 years old, with at least one moderate to severe chronic condition (heart failure, diabetes mellitus, COPD). Social needs must also be identified (e.g. social isolation, insufficient or inadequate social or family support, need for environmental monitoring). Within each group, a stratification was carried out according to two different pathways (50 users were recruited within the short-term care pathway and 50 users participated in the long-term care pathway).
FVG’s outpatient care (“usual care”) served as a comparison group for the study’s intervention group. It was man-datory for both intervention organisation and information flows to be identical to the ones currently used. However, in order to allow for comparison between the intervention and control arms of the study, a minimum dataset of information was collected: user’s personal database, vital parameters, clinical history, social condition, therapy, que-stionnaires on QoL, empowerment, adherence, outcome according to number of contacts, number of hospitalisations and length of stay (including admissions to intermediate care facilities and/or nursing homes), cost-effectiveness parameters.
The target sample population for the project was made up of care recipients suffering from heart failure, COPD and diabetes, with some degree of social needs / social isolation. If the outcome of the study is positive, future ICT-sup-ported integrated interventions may cover other diseases such as Parkinson, Alzheimer, etc.
Each one of the 20 Districts was responsible for the recruitment of 5-15 users, according to district’s capacity, organisa-tion, space availability, and supply size. In order to ensure the enrolment of the planned number of users, competitive enrolment was carried out within the 20 regional Districts, without setting a maximum number of participants per district.
SmartCare ICT-based integrated service ensured the simultaneous care of up to 75 users in the intervention group, and up to 100 users for usual care group.
Randomisation was centralised and monitored only by the staff responsible for the healthcare and social care coor-dination who also established and activated, together with COMES, the installation procedures of the home-based integrated ICT-based platform for those users who were randomised to intervention arm.
The randomisation list was drawn up by an independent statistician (Dr Giulia Barbati, Trieste) who had no direct or indirect involvement with users’ screening and/or enrolment procedures. She was appointed sole responsible for the methodology in use (including size of randomisation clusters). She pledged to respecting end users’ privacy and to provide the healthcare / social care Coordination Committee with the relevant randomisation list.
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After identifying an eligible end user, and having collected his/her informed consent, the Care Team (in the person of the case manager or any other Care Team representative) contacted the Committee responsible for healthcare and social care coordination to activate the randomisation procedure.
The representative of the Care Team provided the Coordination Committee with the user’s initials, sex, date of birth, randomisation number, including end user’s Healthcare Authority and District number, allocation pathway, and con-secutive number of enrolled participants (e.g. AAS1, D2 (district 2), S/L (short vs long term), 01 (1st enrolled user): e.g. AAS1D2STI01; the Coordination Committee then allocated end users to intervention or usual care conditions. In case of randomisation to intervention group, communication was provided to COMES for planning of device installation and activation.
End users randomised to ‘intervention’ treatment condition (ICT-based integrated home care) were compared to ‘usual care’ users, i.e. citizens living within the same FVG districts, with similar healthcare and social care needs. Following stratification into the two pathways identified by the Project (short-term pathway for post-acute users, and long-term pathway for citizens with chronic conditions) a minimum dataset of clinical, healthcare and social care variables was recorded for all end users (both intervention and usual care participants).
The starting point of both pathways was defined at the time when enrolment in SmartCare was suggested to an eli-gible user during his/her hospitalisation for post-discharge short term monitoring (3 months). The eligible participant could be signalled by the hospital physicians or nurses, or by the District nurse. For the long-term monitoring pathway (12 months), the eligible participant could be identified by the Single-Access Point (Punto Unico di Accesso – PUA), through a request made by a GP, an informal caregiver, a family member, the nurse responsible for domiciliary care, the Intermediate Care facility manager, etc. 3.4 Methods: Setting
Two integrated-care pathways (for post-acute care and chronic care) have been identified, both involving Districts and the presence and interaction of multidisciplinary teams.
In the post-acute care, the care recipient who is hospitalised following worsening of his/her chronic disease (heart failure, diabetes, COPD) and who presents social care needs (evaluated as per ≥1 BADL) is signalled to the District nurse by the hospital physician or nurse. The District nurse goes to the hospital, collects all the relevant information, and fills out the ValGraf instrument (geriatric multidimensional, longitudinal assessment). A joint assessment follows, shared with the SmartCare Team, already existing or identified within the District Multidimensional Assessment Unit (Unità di Valutazione Multidimensionale Distrettuale UVMD). Such an assessment is carried out together with the domiciliary care nurse, social worker, district physician, GP, possibly specialists, formal and informal caregivers. An individualised care plan (PAI) is then drafted, and a case manager appointed, who is responsible for the implemen-tation and update of the plan.
In chronic care, the eligible care recipient is living at home and is identified as having complex healthcare needs (chronic disease such as moderate to severe heart failure, diabetes, COPD), as well as social care needs (namely a need for environmental monitoring), though for project purposes identified as per ≥1 BADL). This is signalled to the PUA by the nurse delivering home care, GP, informal caregiver, family member, Intermediate Care Facility personnel, etc. After an initial assessment, a ValGraf form is used (geriatric multidimensional, longitudinal assessment). A joint assessment follows, shared with the SmartCare Team. Such an assessment is carried out together with the domiciliary care nurse, social worker, district physician, GP, specialists (if necessary), formal and informal caregivers. An indivi-dualised care plan (PAI) is then drafted and a case manager appointed, who is responsible for the implementation and update of the plan.
24
3.5 Methods: Participants
246 participants were screened for inclusion. 201 were found eligible. Inclusion criteria for SmartCare project participants:• Age >50 (inclusion cut-off for the SmartCare project).• At least one moderate to severe chronic condition (heart failure, diabetes mellitus, COPD).• End user with social needs: social isolation, insufficient or inadequate social, or family support, need for environ-
mental monitoring. Identification of social frailty will be made as per one BADL missing item.• Signed informed consent.
Exclusion criteria:• Inability to take active part in the project, even with adequate caregiver support (dementia / mild to severe co-
gnitive impairment as per MMSE<24), mental illness (e.g. major depression, legal incapacity).• Presence of a terminal disease with ≤ three months’ life expectancy.• Lack / inadequacy of technical / communication support for ICT-platform use.
3.6 Methods: Data sources / measurement
Data were collected at randomisation and throughout the intervention period from patient documentation, hospital charts, on-line patient health records, and district nurses during home access or “da remote”. Clinical / vital parame-ters were automatically collected for the intervention group through devices and hubs in the ICT platform.
Data was collected through the SmartCare ICT platform. All information recorded on the platform is automatically uploaded. Manually input data (e.g. DoB) are cleaned and corrected every month after data download. If a discre-pancy shows with set thresholds during system service, the call centre intervenes, and calls to ask for a new measu-rement to take place.
To collect health and environmental parameters, we used:• A&D blood pressure monitor.• Nonin Onyx II 9560 pulse-oximeter.• 1-lead ECG.• Fora weight scale.• Fora DM20 blood glucose monitor.• Smart Walker detecting the patient’s movements and sending an emergency signal if a fall occurs.• Help ME button for the patient’s requests of assistance.• Various Z-Wave protocol environment sensors.
Data were systematically controlled by Health and Social Regional Board on regional DWH (vital status, hospitalisa-tion, ICD10 codes). Data from ICT platform were regularly checked by call centre and district nurses for the presence of alarms and during home access. Clinical data were randomly verified (a “champion”) by Health and Social Re-gional Board during regular audit.
The systematic control of all the collected data makes us confident that the collected data are valid.
3.7 Methods: Bias
To minimise the risk of bias, it was decided to carry out randomisation with enrolment into the intervention or usual care group. The randomisation needed to be stratified according to relevant pathways and clustered for every distri-ct. The two groups were similar with regards to the main characteristics so as to be really comparable.Sample size was calculated according to evaluation of different states. It was decided at consortium level without carrying out sample size calculation. As requested, we randomised 200 patients along two pathways.
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3.8 Methods: Statistical methods
The continuous variables (age, height, weight, systolic and diastolic blood pressure, heart rate) showed a normal distribution. Conversely, given the different characteristics of subjects due to inclusion criteria (heart failure and/or COPD and/or diabetes), the following showed a non-normal distribution: Charlson index score, number of pre-scribed drugs, oxygen saturation, blood glucose, number and days of admission, total contacts, home access and phone contacts.
The types of independent variable include ordinal, scale or categorical, shown below with number of measurements of each variable:• Ordinal variables:• one measurement: education, NYHA.
• Scale:• one measurement: age, status of patients (drop-out, active, end-of follow-up), days of follow-up, contacts,
number of prescribed drugs, Charlson index (total score), height, weight.• more than two measurements: oxygen saturation, blood pressure, heart rate, lab tests:
• Categorical:• one measurement: inclusion criteria (yes/no), social status, civil status, Charlson index (single variable: yes/
no).
Since follow-up is different among patients and between different pathways, time is included in the analysis to adjust the number of hospital events for the time unit of measurement.
No tests of interaction were performed in our analyses.
Comparison between statistical analyses was performed in relation to:• Data were collected on ICT platform, according to the types of variables (scale, ordinal and categorical values).
Appropriate training of care provider was performed at the beginning of the project. All dependent variables (admissions and contacts) were systematically checked one by one by the project regional health coordinator. A sample check of data collected by each district was also performed. Summary statistics of clinical variables were expressed as mean and SD, or percentage, as appropriate.
• Comparison between intervention and control groups was performed according to intention-to-treat method. Comparisons between groups at baseline were made using the ANOVA test for continuous variables and the chi-square test for discrete variables. The comparison between groups (adjusted for length of follow-up) on contacts and admissions were performed using ANOVA and linear regression tests. Linear regression test was adjusted for age and gender values.
The chosen level of statistical significance was p=0.05.
All calculations were performed using IBM SPSS 19.0 for Windows (IBM Corp).
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3.9 Results: Participants
To minimise the risk of bias, it was decided to carry out randomisation with enrolment into the intervention or usual care group. The randomisa
Allocate to control (usual care) (n=101)• Receivedallocatedusualcare(n=94)• Didnotreceiveallocatedusualcare- withdrew consent) (n=2)- prolonged hospital admission (n=5)
Lost to follow-up intervention group: consent withdrawn, move to another region, technical problems (n=7)Discontinued intervention during hospitalizations (n=35)
Lost to follow-up control group: consent withdrawn, move to another region (n=7)Discontinued usual care during hospitalisation, intermediate care or nursing home (n=39)
Analysed intervention group (n=88) Excluded from analysis (n=0)
Analysed control group (n=94) Excluded from analysis (n=0)
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3.10 Results: Descriptive data
Baseline demographic characteristics refer to 201 randomised patients (100 intervention vs 101 usual care). Due to 19 early drop-out (12 intervention vs 7 usual care), the analysis included 182 cases (88 intervention vs 94 usual care) followed for 7.1±3.8 months (119 patient-year). End users were elderly (mean age 81 years), 53% of them male, with several comorbidities (Charlson index ≥5 in 44.5%) and prescribed medications (≥7 in 58%). Heart failure was present in 79% of cases, COPD in 38%, diabetes in 68%. Most cases showed a low level of education (primary school in 58% of end users); 38% were living alone, and 42% were reliant on care.
Overall, our analyses showed that integrated care supported by ICT in elderly people with heart failure, COPD or diabetes neither significantly reduced the number, type or length of admissions (hospital, intermediate care, nursing home), nor the number and type of contacts. In the intervention group, total days of hospital stay showed a trend towards a reduction, while contacts tended to increase. Randomised groups were comparable with respect to demo-graphic and clinical characteristics.
Our data should be interpreted with caution in view of the fact that the sample enrolled in our region did not have sufficient statistical power to demonstrate the efficacy of integrated telemonitoring of chronic subjects with complex needs.
Nevertheless, our population was stratified in two arms according to the long-term (chronic) or short-term (post-di-scharge) pathway. While in the long-term pathway no difference was seen between the two groups, in the setting of the vulnerable post- discharge period, telemonitoring appears to be one of the more promising interventions to reduce the risk of rehospitalisation; the intervention group did not significantly change the number of hospitalisations but did significantly reduce the number of days of hospitalisation (in hospital, intermediate care or nursing home). The results seem to be driven by heart failure patients. On the other hand, the activation and follow-up of remote telemonitoring programme required (at least in the first months) an increase in the consumption of human resources which results in a significant increase in unplanned home access.
Table 2: Descriptive characteristics of the study population by group
General data:• 201 randomised patients (100 Intervention vs 101 Usual).• 19 early drop-out (12 Intervention vs 7 Usual care; 12 Short-term post-discharge vs 7 Long-term chronic).• 182 patients followed (88 Intervention vs 94 Usual care).• Follow-up 7.1±3.8 months (119 patient-year):• Intervention vs Usual care: 6.7±3.8 vs 7.4±3.8 months;• Short-term post-discharge vs Long-term chronic: 4.1±1.3 months vs 9.9±3.3 months).
• Events (16 deaths; 126 hospital / health care facility admissions; 1758 days of stay)• 16 deceased patients (8.8%; 13.4 deaths/100 patient-year);• 108 hospitalisations (1342 days of hospital stay);• 18 intermediate care / nursing home admission (416 days).
• Home nursing healthcare: 3053 total contacts (2.14 per-month); 2417 (79.2%) home care, 160 (6.6%) unplan-ned; 536 (20.8%) phone calls.
• There were more total contacts, physical and phone contacts in the intervention group, but these differences were not statistically significant (Table 3).
Table 3: Distribution of contacts to different sectors according to group of service*
Type of contactTotal, Mean (SD)Physical (N), Mean SDTelephone (N), Mean SD
Intervention1655,
18.8 (19.5)1349,
15.3±18.3306,
3.5±4.7
Control1398,
14.9±17.61068,
11.4±16.9330,
3.5±5.8
p-valueNSNSNS
Intervention1635,
18.6 (19.5)1329,
15.1±18.3306,
3.5±4.7
Control1398,
14.9±17.61068,
11.4±16.9330,
3.5±5.8
p-valueNSNSNS
Intervention20,
0.2 (0.88)20,
0.2 (0.88)0
Control000
p-valueNSNS
Voluntary (third sector) contacts
None
* Multiple categories may apply
All contacts Hospital sector contacts Social care sector contacts
30
During an average follow-up of seven months, 16 subjects died (8%), without significant difference between interven-tion and control group. In all, there were 126 hospital admission and 1758 days of hospital stay. In this case, in spite of the absence of any significant difference between intervention and control group, there was a trend towards a reduction of hospitalisation, and in particular of days of hospital stay, in intervention group (Table 4). This difference was statistically significant in the short-term pathway (Figure 2).
The system was very efficient, connection problems were rare, and system break-down absent.
Table 4: Distribution of mortality, morbidity, and technical safety measures according to group of service
Variable/measurement
MortalityDeaths, N (%)MorbidityTotal admissions (N)Total days of hospital stay (N)Subjects with any specific health outcome, N (%)Technical safetyConnection problems, N (%)System break-downs, N (%)Missed messages, N (%)
All N 201
16 (4,5%)
1261758
74 (41%)
2 (1%)0
NA
Intervention N 100
9 (9%)
51586
35 (40%)
2 (2%)0
NA
Control N 101
7 (7%)
751172
39 (42%)
00
NA
Difference (p)
NS
NSNSNS
NSNANA
Figure 2: Hospital admissions and days of hospital stay per patient-month in short-term pathway
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3.12 Discussion
3.12.1 Key results
The three main results of our programme of integrated telemonitoring in chronic subjects affected by heart failure, COPD or diabetes are:
1) The integrated telemonitoring programme with a user-friendly ICT platform is feasible under the responsibility of district nurses who showed they were able to manage chronic elderly subjects followed in home care, or on discharge from hospital.
2) The integrated telemonitoring programme seems more effective to prevent or shorten re-hospitalisation in subjects with heart failure selected at discharge from hospital in comparison with long-term care for those with chronic and complex health and social needs, followed at home by district nurses.
3) The integrated telemonitoring programme requires some investment in term of human resources, since the activa-tion and follow-up of subjects requires education of care providers, patients and caregivers and prompt reaction, with more frequent home access in case of alarms.
3.12.2 Limitations
The interpretation of our results requires some caution, since our sample did not show sufficient statistical power to draw definitive conclusions. First of all, to interpret the neutral results documented in the overall population, it is necessary to take into account the heterogeneity of enrolled population (different etiologies, different pathways) and of the integrated care pathways and clinical competence in the clinical management of chronic complex patients in different districts of our region. Conversely, in the homogeneous population of subjects enrolled at discharge from hospital, and particularly in those affected by heart failure, the results were convincing, as expected by many years of experience in the field and literature data. Note also the possibility to have underestimated the results of the tele-monitoring programme, since it was implemented in a historical period of political reform of the regional healthcare system, and involved district nurses not fully experienced in the intensive clinical management of chronic complex elderly patients. Also, the integration between health and social care providers and implementation of multidiscipli-nary teams is gradual and requires time.
3.12.3 Generalisability
Essential prerequisites for the success of the programme include: the presence of integrated care pathways between hospital and primary care; the role of case manager of experienced district nurses, as part of integrated multidiscipli-nary team; and the selection of cases with complex needs, but specifically at high risk of re-hospitalisation for recent instability and hospital admission.
The results could be replicated in different places, if the main rules of the programme are maintained: continuity of care, integrated network, experienced nurses with clear definition of roles, flow charts and responsibilities, formal involvement of multidisciplinary team.
The implementation of ICT supported integrated care to monitor chronic subjects required more time to activate and implement the new programme, educate the care providers, patients and caregivers, and to guarantee strict remote monitoring of cases. The major consequence was the need of about four more contacts (mainly home access) per subject (average follow-up seven months).
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4 Domain 4: Patient perspectives
4.1 Methods
PAM, WHOQOL-BREF and eCCIS was used in this study.
4.2 Patient Activation Measure (PAM)
The Patient Activation Measure (PAM) is a 22-item questionnaire that assesses patient knowledge, skill, and confiden-ce for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure.
Questionnaires were hand delivered both to end users and caregivers. Each questionnaire was self-reported. Re-spondents’ answers were subsequently uploaded on the platform. Data were electronically uploaded on the platform database. No missing values were reported.
The PAM assessment score provided by Insignia was used to analyse results. Comparison was carried out only among end users tested at the beginning of service and six months later.
The response rate was 117 out of 182. See Table 5 for the results.
4.2.1 Estimation of subscales
The care recipient’s answers to the PAM can be used to estimate a number of subscales:• Believes active role is important (question 1 & 2).• Confidence and knowledge to take action (questions 4, 5, 6, 7, 8, 9).• Taking action (questions 10, 11, 12, (3*)).• Staying the course under stress (question 13).The predictive values of the subscales have been tested based on empirical data1.
4.2.2 Presentation of subscale results
Active roleConfidence andknowledgeTaking actionStaying the courseTotal PAM score
Number
122366
18361732
Range
I-5I-5
I-5I-5I-5
Baseline
3,18 (0,91)3,06 (1,01)
3,15 (1,08)3,19 (1,12)3,11 (1,02)
At 6 months
3,27 (0,82)3,11 (0,88)
3,13 (0,96)3,18 (1,02)3,15 (0,91)
Mean difference after 6 months (CI 95%) Mean (CI to CI)
1Hibbard JH, Stockard J, Mahoney ER, and Tusler M (2004). Development of the Patient Activation Measure (PAM): Conceptualizing and measuring
activation in patients and consumers. Health Services Research 39 (4), Part I.
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4.2.3 Interpretation and discussion of findings
Even though the six-months’ patient activation seems to be either improving, or stable, statistical analysis does not show any significant improvement. The present findings do not infer any meaningful conclusion and/or any impli-cations.
4.3 eCare Client Impact Survey (eCCIS)
At the end of the study, eCCIS was collected from 45 subjects out of 88 intervention users. Reasons for non-respon-ding were: death, hospital admission, lost to follow-up, not directly involved in self-monitoring activities.
Out of a total of 45 respondents:• 26 end users experienced a positive increase in motivation;• 35 experienced a better emotional wellbeing;• 30 experienced a greater ability to perform daily physical activities;• 30 had a reduction in anxiety;• 29 felt less lonely;• 19 experienced an improvement in their relationship with their family carer;• 29 experienced an improvement in their relationship with their professionals;• 35 felt a general improvement in their ability to manage their health condition;• 39 expressed satisfaction with the service; and• 39 felt the service was well worth the effort and would continue to use it.
Active roleConfidence andknowledgeTaking actionStaying the courseTotal PAM score
Number
122366
18361732
Range
I-5I-5
I-5I-5I-5
Baseline
3,18 (0,91)3,06 (1,01)
3,15 (1,08)3,19 (1,12)3,11 (1,02)
At 6 months
3,27 (0,82)3,11 (0,88)
3,13 (0,96)3,18 (1,02)3,15 (0,91)
Mean difference after 6 months (CI 95%) Mean (CI to CI)
Control GroupPhysical (Transformed)Psychological (Transformed)Social relations (Transformed)Environment (Transformed)Valid N (listwise)Intervention GroupPhysical (Transformed)Psychological (Transformed)Social relations (Transformed)Environment (Transformed)Valid N (listwise)
N°
92
92
92
92
92
87
87
87
87
87
Min
14,29
25,00
16,67
25,00
17,86
20,83
0,00
18,75
Max
64,29
75,00
83,33
87,50
67,86
79,17
83,33
90,63
Mean
39,91
46,29
58,06
56,28
41,91
45,50
55,84
56,57
SD
11,69
11,03
13,87
12,12
10,37
11,64
17,14
13,53
N°
62
62
62
62
62
49
49
49
49
49
Min
14,29
25,00
16,67
28,13
14,29
20,83
25,00
34,38
Max
64,29
75,00
91,67
87,50
71,43
79,17
100,00
90,63
Mean
41,07
46,98
58,60
56,80
44,46
46,77
59,18
59,69
SD
11,72
11,15
14,51
12,46
10,13
11,82
15,08
12,26
Baseline (T1) Final (T2)
This is a brief preliminary analysis following on the collection and scoring of WHOQOL- BREF’s data.
This exploratory comparison shows some positive trends for the intervention group, not present in the control arm of the study. Notably, the mean average of Social Relations and Environment domains rose from 55.84 to 59.18 and from 56.57 to 59.69 respectively, during the second year of the trial.
These rises are also present for the minimum and maximum scores, namely for those related to Social Relations. At T2, SD decreases in these domains, thus providing a more stable intervention group.
A similar improvement is shown within the Physical and Psychological domains: the mean for the Physical domains rise from 41.91(T1) to 44.46 (T2), while the Psychological domain shows a less marked rise, rising from 45.50 to 46.77.
In order to carry out a comparison between intervention and control groups, we excluded both dropouts and those users who died or did not fill out the questionnaire at the end of the study. The analysis performed on variations between the beginning and end of the trial period between intervention and control groups did not show any signi-ficant modification in either group. Hence, improvements in the assessed time period concern Physical, Environment and Social Relations, with a lower degree of improvement in the Psychological domain. Hence, as stated above, no significant improvements have been identified between T1 and T2 time intervals.
4.5 Process evaluation
4.5.1 Individual care recipient experiences - Round 1
Care recipient 190 yrs old female, ischemic and hypertensive cardiopathy, COPD, diabetes, chronic renal failure. Living alone, was initially unsure about handling devices. After training, acquired self-confidence and asked for regular weekly calls from the Call Centre staff.
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Care recipient 263 yrs old male, post-infarction cardiopathy, NYHA IV heart failure, severe COPD on oxygen therapy, diabetes, mul-tiple allergies. Being computer-literate, training and use of platform and devices was not a problem. Close monitoring also provided relief to family members, overloaded by the burden of care.
Care recipient 375 yrs old male, post-infarction cardiopathy, bypass, NYHA IV heart failure, severe COPD on oxygen therapy, dia-betes type. CR was heavily dependent on his wife. She was in charge of measurements and contacts with healthcare / social care providers.
4.5.2 Individual care recipient experiences - Round 2
Care recipient 465-year old male, suffering from COPD on oxygen-therapy, heart failure, living alone with some social support (ex-wife, daughter) and with very limited mobility. Was initially sceptical, but quickly learned how to use the devices and greatly appreciates the fast exchange of communication about his health condition. However, feels lonelier than before.
Care recipient 583 year-old female, suffering from hypertension, degenerative cardiopathy, diabetes, severe arthrosis, living alone but with good social support; appreciates the sense of security coming from being so closely monitored. Some minor issues emerged related to devices’ battery replacement, but these were solved thanks to cooperation between help desk and district nurses. Diabetes was identified at an early stage thanks to close monitoring. Care recipient had trouble using the fall alert device because of her severe arthrosis. The issue was solved by putting in a pocket. Care recipient has grown accustomed to routine, and states this helps make her aware of the need to better monitor her health, and makes her very appreciative of the clinical and social support that allows her to feel more comfortable and safer.
Care recipient 677-years old female, suffering from NYHA II heart failure, obese, osteoporosis, glaucoma, living alone with no social network; finds monitoring and platform handling a good way to feel safe and secure. Technology is good, however personal contacts also do make the difference. She would appreciate a strengthening of social support’s network (Third Sector).
4.5.3 Summary
During the first rounds of interviews, CRs were mostly thrilled with the new experience, but still did not possess com-plete awareness of the whole concept of integrated care. They were more focused on the different steps they had to take every day (e.g. getting on the scale, measuring their BP, glucose, etc.) and the thrill for the new experience was coupled with some concerns about ability to properly use the devices.
During the second round of interviews, all care recipients came to appreciate the effectiveness of the platform and the added sense of safety and security coming from a close monitoring and integrated sharing of information. Some issues emerged on the need for added social support, namely in those care recipients with little or no social networ-king. Also, apparently trivial issues such as battery changing need consideration, also given the frailty coming from old age (e.g. difficulty in executing fine hand movements).
Between round 1 and 2 of interviews, the feeling of safety and security has improved. Also, care recipients all felt very comfortable with their daily monitoring and self-care routines. The new roles played by care recipients and formal carers have highlighted some organisational change management issues (who does what, when) to help care pathways work more smoothly. Overall, the experience seems to have added value to usual care interventions.
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5 Domain 5: Economic aspectss
Please see WP9.
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6 Domain 6: Organisational aspects
6.1 Structure
6.1.1 Communication
ICT supported platform has created a healthcare / social care community where each stakeholder can communicate with others in real time and remain updated on CR’s health and social status. This is particularly useful for e.g. nurses or social workers who take up new CRs and can access the CR’s health and social history at a glance. GPs may also benefit from a holistic approach to their patients.
Table 6: WHOQOL - BREF results
Professions
Hospital staffGPHome nurseSocial worker
Average no. of log-ins per week
04.2
47.026.8
Average no. of users per week
01.7
13.32.7
Access
6.1.2 Service integration aspects
Table 8: Overview of facilitators and barriers
FacilitatorsTechnicalSystem is easy to use.
OrganisationalMotivated and proactive SmartCare HC/SC and technical team.
AdministrativeEconomic
Barriers
BP cuffs had to be refitted for smaller, frail CRsWeight scale was not easy to use for some elder CRs.For some stakeholders with low computer literacy loading data on the platform takes a long time.
Some stakeholders unwilling to participate due to lack of economic incentives.
No budget for local imple-mentation was provided thus hindering recruitments
Facilitators
System is easy to use. Stakeholders are aware of the benefits derivingfrom a simple yetrefined integrated care approach.Sending data automatically from the devices is a plus for all CRs.
Support from regional and local health AuthoritiesICT-platform allowed GPs to early assess clinical issues (HF, diabetes) and promoted GP’s central role.Increasing support and awareness of professionals
Reduction of inappropriate visits
Barriers
Chain of communication and interventions for minor issues such as battery replacement had to be revised.Still some issues with the scale.Battery replacement may be difficult for some CRs suffering from severe arthrosis / arthritis.
GPs participation still below par.Change management issues, e.g. some nurses having difficulty in taking on more proactive roles.
No budget for local implementation was provided thus hindering recruitments
3 months after implementation 6 months after implementation
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6.2 Process
6.2.1 Work flow and/or care pathways6.2.1.1 Short-term care after hospital discharge
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6.2.2 Usual Care
Entry point: Currently, at entry point, usual care recipients suffering, e.g. from heart failure (NYHA III-IV) with COPD on continuous oxygen therapy may be admitted into the local hospital due to worsening of dyspnoea. The hospital staff alert the relevant District. The District sends a nurse within 48 hours to meet the patient and his/her relatives, talk to the hospital staff, and start gathering all the relevant information needed on discharge.
Discharge from hospital: According to current practice, after hospital discharge, the patient goes home and usually finds all the needed equipment available (bed, wheelchair, etc.). Follow-up and continuous home care is activated upon discharge as well. The Case Coordinator will provide home-care services according to patient needs.
Assessment of the service user’s needs for integrated care: Currently, no shared data collection system exists. The District nurse activates the relevant healthcare services according to identification of specific clinical and psycho-social needs. There are different systems for electronic storage of patients’ data (clinical and social).
ICT-based enrolment: No ICT-based enrolment procedure currently exist. At present, pre- discharge individuation of case and provisional clinical and social risk stratification allow to send to the District the request for “protected discharge”.
6.2.1.1 Short-term care after hospital discharge
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Initial integrated home care plan: Today, on discharge a discharge plan is made by the District nurse, or the Case Coordinator who will complete the Val. Graft multidisciplinary, multidimensional, longitudinal assessment and evaluation form. The Val.Graf is a health and social care assessment. On-site provision of formal social care: Today, social care is activated on request by the District nurse. Social workers have difficulties being part of a steady communication flow. This may delay their interventions.
On-site provision of formal health care: At the moment, the patient’s Case Manager arranges for and pro-vides formal healthcare. Communication is fragmented, and it takes place through phone calls, fax messages, or during District team meetings.
On-site provision of informal care: Even though the caregiver’s presence and collaboration is vital for the patient’s care, at present, caregivers (family members, or friends) play a secondary role within the care plan, and do not have access to the patient’s information, nor are they able to help adjust the care plan, except through individual contacts with physicians or nurses. The family is directly and formally involved only in the case of meetings aimed at establishing need and eligibility for economic support.
Remote provision of health / social care to the home (telecare, telemonitoring): For all FVG regions, remote home health and social care services are provided by external company with ad hoc 24/7 Call Centre.
Integrated documentation of home care provided / self-care measures: Though integrated care does exist, no real integrated communication takes place given the fragmentation of roles and services.
Control / reassessment of the home care recipient: Integration of data into care planning and management processes is updated at three months to decide whether to end home care plan or prolong it up to six months only through District meetings.
Temporary admission / re-admission to an institutional setting: In usual care, integration of information is fragmented at this point in time.
Within the usual care process, informal carers may attend each District’s team meetings. However, they play a more passive role, and though often burdened with responsibilities, they work on the sidelines and have to spend time and energy to obtain information on their loved one’s status.
6.2.3 SmartCare revised care
As stated above, SmartCare ICT solution will support the traditional health / social care interventions, making shared communication and real time information faster and smoother. Additionally, by providing home health and environmental monitoring of the care recipient, it will intensify day-to-day monitoring of his/her clinical conditions, thus allowing more efficient and effective interventions to prevent destabilisations and hospital admissions.
SmartCare – entry point: The Smart Care platform has been developed to improve and enrich information about previous healthcare pathways (i.e. identification of previous needs and actors involved in patient’s care), so as to activate prompt action upon discharge. The District nurse carries out a pre-assessment on the basis of the information available. At this time, patients may be asked to sign a pre-enrolment consent form.
Discharge from hospital: In SmartCare, the multidisciplinary team will be led by a Case Coordinator chosen to meet prevailing needs. Monitoring of vital parameters (BP, HR, weight, SO2, etc.) as well as environmental data or videoconferencing device (only for selected cases) is made available on a daily basis through external service or integrated platform to all care providers. Questionnaires and notes add to the clinical information, thus providing thorough information. Assessment of the service user’s needs for integrated care: In SmartCare, the District Nurse is in charge of completing the assessment by contacting all parties involved in the multi-disciplinary team approach. Subsequently
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and according to specific needs, a Case Coordinator is appointed among the members of the multidisciplinary team, who acts as the reference person for the home care integrated plan. Patient’s final consent has to be signed.
ICT-based enrolment: During the first meeting at the hospital, if the patient is deemed eligible for SmartCare enrolment, the Di-strict nurse asks for consent to enter patient’s data and to share them with other relevant actors within the SmartCare platform. She/he also provides the patient and caregiver with all the basic information on the SmartCare platform, and the possibility to access it directly from home. The nurse also evaluates the patient’s ability to perform home monitoring; if deemed eligible, they are given the opportunity to receive home monitoring equipment. An order is subsequently be sent to the dedicated service, which will send an employee to set up the devices at the patient’s home, while simultaneously introducing the relatives to their use. Through regional Registry of Birth, the nurses collect available information (health and social) from different databases. After collecting and entering the available information, the nurse updates the disease information and relevant health and social care data.
Initial integrated home care plan: In SmartCare the ValGraft assessment is subsequently shared with all the participating actors who are able to proactively start a planned and individualised integrated healthcare care plan. This plan is periodically reassessed and adjusted by the multidisciplinary team. Depending on clinical and social needs, and according to the integrated home care plan, for any case there is a specific target and priority for care (health care e.g. hemodynamic stability for heart failure etc; social care:e.g. food delivery, preparing meals, home sensors, etc.). A multidisciplinary team is activated, led by a Case Co-ordinator. Data and information is constantly shared among the different parties. Goals and needs are adjusted accordingly. SmartCare makes this plan available in real time to all stakeholders.
On-site provision of formal social care: Social care actors are able to access and update Smart Care pla-tform. Depending on social needs and according to the integrated home care plan, for any case there will be specific target and priority of care (e.g. food delivery, preparing meals, home sensors, etc.).
On-site provision of formal healthcare: Healthcare actors are able to access and update SmartCare pla-tform. Depending of clinical needs and according to the integrated home care plan, for any case there are specific targets and priority of care (e.g. hemodynamic stability for heart failure etc.).
On-site provision of informal care: Through Smart Care, family members and/or friends are able, on patient’s request, to access the system and share information on their loved one. This allows them to feel more secure, less isolated, and provides them with better tools to monitor and contribute to the patient’s maintenance of health and QoL, and be more directly involved in the provision of services.
Remote provision of health / social care to the home (telecare, telemonitoring): For all FVG regions, remote home health and social care services are provided by external company with ad hoc 24/7 Call Centre. Smart Care services provide full support to cooperative delivery of care, integrated with self-care and across orga-nisational silos, including essential coordination tools such as shared data access, care pathway design and exe-cution, as well as real time communication support to care teams and multi- organisation access to home platforms.
Integrated documentation of home care provided / self-care measures: Any interventions made by the various parties are documented in the SmartCare ICT system, and made available to other parties. Depending of home care plan (targets, criticisms, needs, intensity of monitoring), the Case Coordinator plans periodic meetings with District Team. Daily update from CR and home monitoring (clinical and environmental) are provided, as well as periodic update by care team according to care priorities, CR needs, roles of actors.
Control / reassessment of the home care recipient: Integration of data into care planning and manage-ment processes are updated at three months to decide whether to end home care plan or prolong it up to six months. Sharing and analysis of clinical, scheduling, monitoring information continue.
Temporary admission / re-admission to an institutional setting: An Integrated Care Record allows sharing of updated clinical information both in-hospital and out of-hospital care. Updated information provided in emergency situations by a Call Centre is available through a pre-defined printed version. Exit of patient from Smart Care platform is evaluated at the time of readmission according to specific parameters.
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Exit point: At the end of programme, the District Team, on the base of global review of persistent CR needs and results obtained with ICT programme, decides about exit from SmartCare pathway.
6.2.4 Benefits of ICT supported integrated care
The ICT-supported integrated care has added more value to communications between stakeholders, made active CRs part of care pathways, and highlighted social needs of people suffering from chronic disease.
The new ICT-supported integrated care is supporting and enhancing the usual integrated care by providing CRs with better self-awareness and professionals with redefinition of roles and synergies.
6.2.5 Staff and training
The level of education for involved staff ranges from professional school certificates / diplomas to bachelor’s and master’s degrees, together with medical degrees.
Healthcare and social care staff are responsible for the cure & care of our citizens (patients) through all stages of planning and implementation of interventions according to roles and responsibilities.
The platform and its devices have been designed and built in order to offer easy-to-use ICT integration. However, we believe that training is an essential part of change management and retention, so specific training sessions were organised in different formats (group sessions, face-to-face training, and one-to-one experiential activities).
The new tasks that have to be performed as part of both implementation and delivery of ICT supported integrated care include:• Loading new information gathered during home visits on the platform, either through tablets or through a computer.• Loading Valgraf multidimensional assessment form onto the SmartCare platform.• Loading questionnaires.• Updating events, loading any therapy changes, planned / unplanned contacts, and periodical reassessments of
clinical needs.
However, no specific skills are required beyond average computer literacy. No task shifting has taken place. Some nurses have reduced number of contacts and home visits have been re-plan-ned according to actual care recipients’ needs.
6.3 Culture
6.3.1 Individual professional experiences - Round 1 experiences
Professional 1Domiciliary nurse. Stated satisfaction with the presence of a platform which may improve communication and allow streamlining of interventions.
Professional 2Cardiologist. Stated the importance of being able to set alarm thresholds and monitor patient’s clinical parameters. Felt that the platform may have a greater impact on nurses in their planning and execution of everyday work.
Professional 3Social Worker. Stated the importance of communication exchange since the two services have different registries. Appreciated the presence of environmental devices which may better help monitor frail CRs.
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6.3.2 Individual professional experiences - Round 2 experiences
Professional 4GP. Greatly appreciated the improvements in communication and the ability to get the ‘big picture’ and be able to provide earlier diagnosis thanks to the easy and real-time access to different clinical parameters. Also appreciated the ability to access social data for a holistic assessment.
Professional 5Domiciliary nurse. Stated greater efficiency and effectiveness of interventions with easier planning and prioritising. Some minor issues related to battery replacements and the delivery of one glucometer emerged, and were subse-quently solved.
Professional 6District nurse. Appreciated the importance of integrating and sharing information. Looks forward to the platform being able to share information with other existing registries (e.g. hospital) to avoid duplication of multidimensional assessments. Feels that an integrated platform can make frail CRs feel more secure in their own homes and allows sharing of responsibilities among stakeholders.
6.3.3 Summary
The interest in the integrated approach has been evident since the beginning, notably as far as communication was concerned.
The second round of interviews showed greater awareness provided by the actual experience. Both strengths and criticalities were stated. Overall, every stakeholder expressed a clear feeling in favour of the ICT-based integra-ted platform which they considered essential for the future of sustainable healthcare. Some minor technical issues emerged which need to be taken into consideration. The technical and model approach has been validated by all stakeholders.
Overall, between round 1 and 2 of interviews, the initial consensus was confirmed in terms of efficiency and effecti-veness of ICT-supported integrated care.
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7 Domain 7: Social, ethical and legal aspects
7.1 Ethical issues
For legal framework on ethics and data protection please refer to deliverable D10.2 Ethics and data protection framework.
Table 9: Ethical issues
Issue
Care recipient autonomy
Access and equity
Normative CodesAssessment of risk and benefit
Dates
Month 3
Evidence
A care recipient information package and consent form was created. Nurses were trai-ned to deliver oral guidance to eligible participants about: goals, procedures, possible risks, expected individual and collective benefits, alternatives to participation, sharing of knowledge about study’s results, privacy and data protection, participation and wi-thdrawal from the study, identification of operators, measures in place to support end user at the end of the study, and rights of participants’. After exhaustively answering eligible participants’ questions, informed consent was collected, signed by participants. Participants were requested to sign both informed consent and authorisation for han-dling of personal data.In compliance with the terms and indications of Italian Law 196/2003, regulating the treatment of data of persons and other subjects, the processing and handling of perso-nal data needs to be carried out by respecting the rights, fundamental freedoms and di-gnity of natural persons, particularly with regard to privacy and personal identity. Each citizens needs to sign a consent to provide and handle personal data. The consent may be withdrawn at any point in time. Informed consent is required to receive any medical treatment. The Italian Constitution guarantees the inviolability of personal liberty. In par-ticular, consent to medical treatment is covered by article 32 (2) of the Constitution. This article states that nobody may be forced to undergo any particular medical treatment, unless under the provision of the law. That law may in no case violate the limits impo-sed by proper respect of the right to informed consent is also regulated by the Code of Medical Ethics. According to this Code, the physician cannot perform any diagnostic or therapeutic treatment without the consent of the patient (article 32). The consent is part of the informative process regulated by article 30 of the Code, and does not replace it. The physician should respond to the free will to be treated expressed by the person, with regard to the dignity, liberty and independence of the profession (article 34).The consent has to be expressed in a written manner in the cases foreseen by the law and in the cases in which the particularities of the diagnostic and/or therapeutic activities or the potential consequences of these activities make an unequivocal manifestation of the will of the patient opportune. Diagnostic and/or therapeutic procedures which could compromise the physical integrity of the patient can only be undertaken in case of emergency. The physician has to inform the patient on the possible consequences of the proposed procedures and obtain an appropriate informed consent. In case of an informed refusal by a person who is capable of comprehension, the physician must cease any diagnostic and/or curative activity, because no treatment may be allowed without the consent of the person. In case of emergency and in case of any danger to the person’s life, the physician must provide the necessary assistance and care, provi-ded that the patient cannot express his refusal at that time.Care recipients and caregivers received thorough information about the SmartCare services from the District nurse prior to enrolment. Explanations were also provided concerning the fact the randomisation would be implemented, and as a consequence of such a study design, they might be randomly assigned either to the intervention or to the control arm.
How issue was addressedConsent to enrol-ment & privacy
Informed Consent
Randomisation prevents any bias (the control group receives the usual level of care).
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7.2 Legal issues
For legal framework on ethics and data protection please refer to deliverable D10.2 Ethics and data protection framework.
Table 10: Legal issues
7.3 Social issues
Table 11: social issues
Issue
Clinician accreditationDevice certification
Information GovernanceProfessional liability
Dates
Month 1
Month 1
Evidence
Same as in usual care.
Class IIa Medical Device software platform and devices. The system’s hardware and software are fully redundant and are hosted by a data centre with ISO 27001 certifi-cation for data security and business continuity.
See deliverable D10.2 and operational protocol.
See above.
How issue was addressed
Public tender explicitly required that both ICT- platform and devices be medically certified to ensure safety and security.
Issue
Changes in care recipient’s roles
Care recipient’s relatives and othersSocietal, political and context changes
Changes in responsibilities
Gender issues - equity
Evidence
Qualitative interviews, statements from formal sta-keholders.
Results of PAM and eCCIS.
Support from FVG and Healthcare Ministry with extension of regional support to integrated care activities.Focus groups/change management interviews.
Key findings
More direct involvement in self care.Greater sense of security/safety. More symmetri-cal relationships with professional stakeholders.Integrated care enhanced feeling of social sup-port and security.Dissemination and communication work stirred interest and awareness in integrated care.
Nurses and social workers have started taking on more active roles within domiciliary integra-ted pathways.N/A - laws and guidelines already in place.
