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The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly

BACKGROUND: With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail...

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Autores principales: Ruikes, Franca GH, Meys, Antoinette RM, van de Wetering, Gijs, Akkermans, Reinier P, van Gaal, Betsie GI, Zuidema, Sytse U, Schers, Henk J, van Achterberg, Theo, Koopmans, Raymond TCM
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527269/
https://www.ncbi.nlm.nih.gov/pubmed/23216685
http://dx.doi.org/10.1186/1471-2296-13-115
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author Ruikes, Franca GH
Meys, Antoinette RM
van de Wetering, Gijs
Akkermans, Reinier P
van Gaal, Betsie GI
Zuidema, Sytse U
Schers, Henk J
van Achterberg, Theo
Koopmans, Raymond TCM
author_facet Ruikes, Franca GH
Meys, Antoinette RM
van de Wetering, Gijs
Akkermans, Reinier P
van Gaal, Betsie GI
Zuidema, Sytse U
Schers, Henk J
van Achterberg, Theo
Koopmans, Raymond TCM
author_sort Ruikes, Franca GH
collection PubMed
description BACKGROUND: With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly. METHODS/DESIGN: The CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation. DISCUSSION: The CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care. TRIAL REGISTRATION: The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797
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spelling pubmed-35272692012-12-21 The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly Ruikes, Franca GH Meys, Antoinette RM van de Wetering, Gijs Akkermans, Reinier P van Gaal, Betsie GI Zuidema, Sytse U Schers, Henk J van Achterberg, Theo Koopmans, Raymond TCM BMC Fam Pract Study Protocol BACKGROUND: With increasing age and longevity, the rising number of frail elders with complex and numerous health-related needs demands a coordinated health care delivery system integrating cure, care and welfare. Studies on the effectiveness of such comprehensive chronic care models targeting frail elders show inconclusive results. The CareWell-primary care program is a complex intervention targeting community-dwelling frail elderly people, that aims to prevent functional decline, improve quality of life, and reduce or postpone hospital and nursing home admissions of community dwelling frail elderly. METHODS/DESIGN: The CareWell-primary care study includes a (cost-) effectiveness study and a comprehensive process evaluation. In a one-year pragmatic, cluster controlled trial, six general practices are non-randomly recruited to adopt the CareWell-primary care program and six control practices will deliver ‘care as usual’. Each practice includes a random sample of fifty frail elders aged 70 years or above in the cost-effectiveness study. A sample of patients and informal caregivers and all health care professionals participating in the CareWell-primary care program are included in the process evaluation. In the cost-effectiveness study, the primary outcome is the level of functional abilities as measured with the Katz-15 index. Hierarchical mixed-effects regression models / multilevel modeling approach will be used, since the study participants are nested within the general practices. Furthermore, incremental cost-effectiveness ratios will be calculated as costs per QALY gained and as costs weighed against functional abilities. In the process evaluation, mixed methods will be used to provide insight in the implementation degree of the program, patients’ and professionals’ approval of the program, and the barriers and facilitators to implementation. DISCUSSION: The CareWell-primary care study will provide new insights into the (cost-) effectiveness, feasibility, and barriers and facilitators for implementation of this complex intervention in primary care. TRIAL REGISTRATION: The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797 BioMed Central 2012-12-05 /pmc/articles/PMC3527269/ /pubmed/23216685 http://dx.doi.org/10.1186/1471-2296-13-115 Text en Copyright ©2012 Ruikes et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Ruikes, Franca GH
Meys, Antoinette RM
van de Wetering, Gijs
Akkermans, Reinier P
van Gaal, Betsie GI
Zuidema, Sytse U
Schers, Henk J
van Achterberg, Theo
Koopmans, Raymond TCM
The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title_full The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title_fullStr The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title_full_unstemmed The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title_short The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
title_sort carewell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527269/
https://www.ncbi.nlm.nih.gov/pubmed/23216685
http://dx.doi.org/10.1186/1471-2296-13-115
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