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

Abstract

BackgroundWith 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/designThe 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.DiscussionThe 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 registrationThe CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797

Multicomponent Program to Reduce Functional Decline in Frail Elderly People: A Cluster Controlled Trial

“…18,19 Details were published previously. 20 The study was reviewed by the ethics committee of the Radboud University Medical Centre Nijmegen (registration no. 2010/403) and registered at ClinicalTrials.gov (identifier NCT01499797).…”

“…Extended information on the sample size calculation was published in the study protocol. 20 Statistical Analysis Outcomes at the participants' level were analyzed with linear mixed-model analyses to account for the clustering of participants within the GP practices. Outcome estimates were corrected for significant differences in baseline characteristics that correlated with the primary outcome, and for the baseline value of the outcome (in the case of secondary outcomes) by including these variables as covariates.…”

Comprehensive geriatric assessments in integrated care programs for older people living at home: A scoping review

“…Information provided about the exact content of the instrument varied between CGAs. For five CGA instruments, the content of the CGA was available in (the appendix of) the original study or in a study cited in the original study (Buurman et al, ; Buurman, Parlevliet, van Deelen, de Haan, & de Rooij, ; Fleischer et al, ; Ruikes et al, , ; Stijnen, Duimel‐Peeters, et al, ; Suijker et al, , ). For the other CGAs, the original study did not provide or only partially provided the exact content of the CGA nor referred to other papers describing this information.…”

“…Three CGA instruments were tested for their validity and reliability (De Stampa et al, ; Ruikes et al, , ; Van Hout et al, ; Vedel et al, ). For four CGAs, it was explicitly indicated that the instrument was tested for its feasibility (Daniels et al, ; Metzelthin, van Rossum, de Witte, Hendriks, & Kempen, ; Metzelthin et al, ; Ruikes et al, , ; Stijnen, Duimel‐Peeters, et al, ; Suijker et al, , ). For nine CGAs, the average duration of conducting the assessment was described, which ranged from 30 min to 3 hr.…”

“…Furthermore, domains were defined in different ways in CGAs. For example, in some CGAs, cognitive functioning was part of the psychological/mental domain (Kono et al, ; Stijnen, Duimel‐Peeters, et al, ; Suijker et al, , ), while in other CGAs, cognition was a domain separate from the psychological/mental domain (Boult et al, ; Boyd et al, ; Ruikes et al, , ).…”