Clinical trial NCT03042039: Multi-level Integration for Patients With Complex Needs Facilitated by ICTs. A Shared Approach, Mutual Learning and Evaluation Are Expected to Create Synergies Among the Partners and to Bring Forward Integration of Care in Europe
Official title: CareWell - Multi-level Integration for Patients With Complex Needs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Diabetes
Chronic Heart Failure
Frail Elderly Syndrome
Lead sponsor: Him SA
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 1712
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Frail elderly living in one of the 6 CareWell sites

Brief summary: CareWell will enable the delivery of integrated healthcare to frail elderly patients in a pilot setting through comprehensive multidisciplinary integrated care programmes where the role of ICTs can foster the coordination and patient centered delivery care. Carewell will focus in particular complex, multi-morbid elderly patients, who the patients most in need of health and social care resources (35% the total cost of Health Care System) and more complex interventions due to their frailty and comorbidities (health and social care coordination, monitoring, self-management of the patient and informal care giver). ICT platforms and communication channels that allow sharing information between healthcare and social care professionals involved in the delivery care of these patients, facilitating their coordination, increasing their resoluteness and avoiding duplicities when tackling patients´ diagnostic, therapeutic, rehabilitation or monitoring needs. Additionally, ICT-based platforms can improve the adherence to treatment, enhance self-care and increase patient awareness about their health status , as well as, improve the empowerment of informal caregivers, who usually take care of these patients.

According to this, it is hypothesized that the benefit of integrated care programmes based on (1) integrated care coordination and (2) patient empowerment \& home support pathways supported by ICT is greater and essential for these patients. Care pathways will cut across organisational boundaries and will activate the most appropriate resources across the entire spectrum of healthcare and social care services available for both scheduled and emergency care. CareWell aims to scale up the services in pioneer regions and share their approach, learning from and supporting the other pilot sites which are at different levels of maturity in respect to designing, developing and implementing new ways of providing integrated care services.

Detailed description: Frail elderly patients are characterised as having complex health and social care needs; they are at risk of hospital or residential care home admission, and require a range of high level interventions due to their frailty and multiple chronic conditions. A growing proportion of the population in OECD countries are age 65 and over: 15% in 2010, and expected to reach 22% by 2030. More than half of all older people have at least three chronic conditions, and a significant proportion have five or more.

A recent US study indicates that more than 95% of Medicare patients with a chronic disease such as congestive heart failure, depression, or diabetes have at least one other chronic condition, and the majority (80%, 71%, and 56%, respectively) have four or more chronic conditions. The CareWell project deals with multimorbid frail patients. Typically these patients have several diagnoses, the most frequent ones are:

* Chronic Obstructive Pulmonary Disease (COPD),
* Diabetes and
* Congestive Heart Failure (CHF).

The main objective of the CareWell study is to explore the data collection and analysis of health services' use. All sites are requested to upload their available data regarding service use, their flow chart on recruitment, and the demographic characteristics of end users. The evaluation has been conducted using the MAST multi-dimensional evaluation methodology adapted to the needs of CareWell project focusing on integrated healthcare.

MAST includes assessment of the outcomes of telemedicine applications divided into the following seven domains:

1. health problem and characteristics of the application;
2. safety;
3. clinical effectiveness;
4. patient perspectives;
5. economic aspects;
6. organisational aspects and
7. socio-cultural, ethical and legal aspects. Each domain will be addressed and studied through a range of methodological approaches, quantitative, qualitative and modelling.

Patients distributed in six sites will be recruited and assessed at baseline and be followed up during a period of six months. Data is to be collected from different sources, including administrative databases, questionnaires and personal interviews.

All 6 CareWell sites are to conduct cohort studies, which means that a group of people with similar characteristics are followed over a period of time. Potential participants are selected by screening electronic healthcare records and/or the hospital / national databases and/or during long term condition annual reviews in the community setting.

Candidates are informed about the nature and the objectives of the evaluation. Once candidates have signed the informed consent form, if necessary, they participate in the evaluation.

Eligibility criteria: Inclusion Criteria:

1. Age ≥65 years.
2. Presence of at least two chronic diseases included in the Charlson Comorbidity Index (CCI) \[4\]. At least one of the comorbid conditions must be one of the following conditions: Chronic obstructive pulmonary disease (COPD), diabetes mellitus (both insulin-dependent and noninsulin-dependent) or chronic heart failure (CHF).
3. Fulfilling local/national/organisational criteria of frailty: increased vulnerability, complex health needs, and at high risk of hospital or care home admission.
4. Participants have to be able to understand and to comply with study instructions and requirement, either independently or with help from a carer.

Exclusion Criteria:

1. Subjects who have either been registered with an active cancer diagnosis under treatment, have undergone an organ transplant, or are undergoing dialysis prior to enrolment.
2. Subjects who are candidates for palliative care (with life expectancy less than one year, clinically evaluated).
3. People with an AIDS diagnosis.
4. People living in care homes where their daily health, care and wellbeing needs are met by staff (nurses and support staff) employed within the home.

Primary outcomes:
measure: Total number of hospital admissions per participant measured at end of study (at approx 12 months)
timeFrame: Total of hospital admissions as measured after (approximately) 12 months (= end of study)
Secondary outcomes:
measure: Change in generic health related/functional quality of life (1) by assessing Charlson Comorbidity Index (CCI)
timeFrame: Change in CCI between baseline and after (approximately) 12 months (=end of study)
measure: Change in Generic health related/functional quality of life (2) by assessing Barthel index
timeFrame: Change in Generic health related/functional quality of life as assessed based on BARTHEL INDEX scores between baseline and (approximately) after 12 months (=end of study)
measure: Change in Psychological measures (1) by assessing Geriatric Depression Scale
timeFrame: Changes in Psychological measures as assessed based on GDS-SF between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
measure: Change in Psychological measures (2) by measuring Hospital Anxiety and Depression Scale
timeFrame: Changes in Psychological measures as assessed based on HADS measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
measure: Changes in the User perspectives (1) by measuring PIRU questionnaire on user experience of Integrated Care (IC) by measuring Policy Research Unit in Policy Innovation Research questionnaire
timeFrame: Changes in User perspectives as assessed based on PIRU scores between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
measure: Changes in User perspectives (3) by measuring Carer perspectives of integration according to eCCIS
timeFrame: Changes in User perspectives as assessed based on eCCIS measurements of CARERS between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
measure: Changes in User perspectives (4) by measurement of NHS LTC6 Questionnaire
timeFrame: Changes in NHS-LTC6 measurements between baseline, midterm (after approximately 6 months) and after (approximately) 12 months (=end of study)
measure: Economic aspects (1) as measured based on the total of Efforts related to service development & implementation during the study (between start and 12 months)
timeFrame: Economic aspects as assessed based on measurements of total efforts related to Development and Implementation of Services during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Economic aspects (2) as measured based on the total of Efforts related to service during the operation or use of the study (between starts and 12 months)
timeFrame: Economic aspects as assessed based on measurements of total efforts related to Service Operations during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Economic aspects (3) as measured based on the total of Equipment costs during the project, between start and after 12 months
timeFrame: Economic aspects as assessed based on measurements of total of Costs of Equipment during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Economic aspects (4) based on measurements of Service effectiveness benefits during study (between start and 12 months)
timeFrame: Total of Benefits in Effectiveness of Services during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in of Economic aspects (5) based on measurements of Service efficiency benefits during study (between start and 12 months)
timeFrame: Economic aspects as assessed based on measurements of total of Benefits in Efficiency of Services during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Economic aspects (6) based on changes in measurements Changes Willingness to pay between start en end of study (12 months)
timeFrame: Economic aspects as assessed based on measurements of Changes in Willingness To Pay for Services between baseline and after (approximately) 12 months (=end of study)
measure: Impact on Organisational aspects (1) as measured with impact on staff between start and study end (after 12 months)
timeFrame: Total of Services' Impact On Staff during the period between baseline after (approximately) 12 months (=end of study)
measure: Impact on Organisational aspects (2) as measured with impact on involved organisations between start study and end (12 months)
timeFrame: Total of Services' Impact On Organisations during the period between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Overall service effectiveness and specific outcome measures (1) as measured with Admission-Discharge Duration of admissions between start and study end
timeFrame: Changes in Overall service effectiveness and specific outcome assessed based on change between Average of Duration of each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Overall service effectiveness and specific outcome measures (2) as measured with Indication for hospitalisation of all admissions between start and study end (12 months)
timeFrame: Changes in Overall service effectiveness and specific outcome by recording of Admission Indication throughout study between baseline and after (approximately) 12 months (=end of study)
measure: Changes in Overall service effectiveness and specific outcome measures (3) as measured with Re-hospitalisation rates within 30 days after dismissal between start and end study (12 months)
timeFrame: Changes in Overall service effectiveness and specific outcome as assessed based on change between measurements of total of re-hospitalization within 30 days after last admission throughout study between baseline and after (approx.) 12 months (=study end)
measure: Change in Overall service effectiveness and specific outcome measures (4) as assessed with Origin before Admission of all admissions between start and end of study (12 months)
timeFrame: Changes in Overall service effectiveness and specific outcome by recording of Origin ad each Admission throughout study between baseline and after (approximately) 12 months (=end of study)
measure: Change in Overall service effectiveness and specific outcome measures (5) as assessed with Discharge destiny of all discharges between start and end of study (12 months)
timeFrame: Changes in Overall service effectiveness and specific outcome by recording of Destiny after each discharge throughout study between baseline and end of study (12 months)
measure: Change in Disease specific health status measurement (1) as measured with HbA1c of diabetes patients between start and end of study (12 months)
timeFrame: Changes in Disease specific health status based on measurements of HbA1c between baseline and after (approximately) 12 months (=end of study)
measure: Change in Disease specific health status measurement (2) as measured with blood glucose levels of all diabetes patients between start and end of study (12 months)
timeFrame: Changes in Disease specific health status based on measurements of Blood Glucose between baseline and after (approximately) 12 months (=end of study)
measure: Change in Disease specific health status measurement (3) as measured with heart rate measurements of all chronic heart failure patients between start and study end (12 months)
timeFrame: Changes in Disease specific health status based on measurements of Heart Rate between baseline and after (approximately) 12 months (=end of study)
measure: Change in Disease specific health status measurement (4) as measured with blood pressure of all patients with chronic heart failure between start and end of study (12 months)
timeFrame: Changes in Disease specific health status based on measurements of blood Pressure between baseline and after (approximately) 12 months (=end of study)
measure: Change of Disease specific health status measurement (5) as measured with weight of all patients with chronic heart failure between start and end of study (12 months)
timeFrame: Changes in Disease specific health status based on measurements of Weight between baseline and after (approximately) 12 months (=end of study)
measure: Change in Disease specific health status measurement (6) as measured with BMI of all patients with chronic heart failure between start and end of study (12 months)
timeFrame: Changes in BMI between baseline and after (approximately) 12 months (=end of study)
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Higher or Secondary Education Establishments
city: Bari
country: Italy
facility: Agenzia Regionale Sanitaria Pugliese
city: Wroclaw
country: Poland
facility: Urzad Marszalkowski Wojewodztwa Dolnoslaskiego
city: Vitoria-Gasteiz
country: Spain
facility: Servicio Vasco de Salud Osakidetza
city: Bronllys
country: United Kingdom
facility: Bronllys Hospital
Study officials:
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