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

NCT ID: NCT03042039

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1712 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Diabetes Chronic Heart Failure Frail Elderly Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Study group 'New Care'

Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.

New Care

Intervention Type OTHER

New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).

Interventions

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New Care

New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Him SA

OTHER

Sponsor Role lead

Responsible Party

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Wouter A Keijser

General Manager of KRONIKGUNE, the Basque Centre for Health Services Research and Chronicity.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Higher or Secondary Education Establishments

Zagreb, , Croatia

Site Status

Agenzia Regionale Sanitaria Pugliese

Bari, , Italy

Site Status

Urzad Marszalkowski Wojewodztwa Dolnoslaskiego

Wroclaw, , Poland

Site Status

Servicio Vasco de Salud Osakidetza

Vitoria-Gasteiz, , Spain

Site Status

Bronllys Hospital

Bronllys, , United Kingdom

Site Status

Countries

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Croatia Italy Poland Spain United Kingdom

References

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Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.

Reference Type BACKGROUND
PMID: 22617736 (View on PubMed)

Agha Z, Schapira RM, Maker AH. Cost effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemed J E Health. 2002 Fall;8(3):281-91. doi: 10.1089/15305620260353171.

Reference Type BACKGROUND
PMID: 12419022 (View on PubMed)

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.

Reference Type BACKGROUND
PMID: 19001484 (View on PubMed)

Kopec JA, Fines P, Manuel DG, Buckeridge DL, Flanagan WM, Oderkirk J, Abrahamowicz M, Harper S, Sharif B, Okhmatovskaia A, Sayre EC, Rahman MM, Wolfson MC. Validation of population-based disease simulation models: a review of concepts and methods. BMC Public Health. 2010 Nov 18;10:710. doi: 10.1186/1471-2458-10-710.

Reference Type BACKGROUND
PMID: 21087466 (View on PubMed)

Speroff T, O'Connor GT. Study designs for PDSA quality improvement research. Qual Manag Health Care. 2004 Jan-Mar;13(1):17-32. doi: 10.1097/00019514-200401000-00002.

Reference Type BACKGROUND
PMID: 14976904 (View on PubMed)

Hiligsmann M, Gathon HJ, Bruyere O, Ethgen O, Rabenda V, Reginster JY. Cost-effectiveness of osteoporosis screening followed by treatment: the impact of medication adherence. Value Health. 2010 Jun-Jul;13(4):394-401. doi: 10.1111/j.1524-4733.2009.00687.x. Epub 2010 Jan 21.

Reference Type BACKGROUND
PMID: 20102558 (View on PubMed)

Lega F, DePietro C. Converging patterns in hospital organization: beyond the professional bureaucracy. Health Policy. 2005 Nov;74(3):261-81. doi: 10.1016/j.healthpol.2005.01.010.

Reference Type BACKGROUND
PMID: 16226138 (View on PubMed)

Mateo-Abad M, Gonzalez N, Fullaondo A, Merino M, Azkargorta L, Gine A, Verdoy D, Vergara I, de Manuel Keenoy E. Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country. BMC Health Serv Res. 2020 Jul 3;20(1):613. doi: 10.1186/s12913-020-05473-2.

Reference Type DERIVED
PMID: 32620116 (View on PubMed)

Related Links

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Other Identifiers

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CareWell_EC_Grant No. 620983

Identifier Type: -

Identifier Source: org_study_id

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