title: The CareWell-primary care program: design of a cluster controlled trial and process evaluation of a complex intervention targeting community-dwelling frail elderly.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The CareWell-primary care study is registered in the ClinicalTrials.gov Protocol Registration System: NCT01499797.
authors.affiliation: Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. f.ruikes@elg.umcn.nl
authors.forename: Franca G H
authors.initials: FG
authors.lastname: Ruikes
authors.forename: Antoinette R M
authors.initials: AR
authors.lastname: Meys
authors.forename: Gijs
authors.initials: G
authors.lastname: van de Wetering
authors.forename: Reinier P
authors.initials: RP
authors.lastname: Akkermans
authors.forename: Betsie G I
authors.initials: BG
authors.lastname: van Gaal
authors.forename: Sytse U
authors.initials: SU
authors.lastname: Zuidema
authors.forename: Henk J
authors.initials: HJ
authors.lastname: Schers
authors.forename: Theo
authors.initials: T
authors.lastname: van Achterberg
authors.forename: Raymond T C M
authors.initials: RT
authors.lastname: Koopmans
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D017028:Caregivers; D019090:Case Management / Q000191:economics; D017281:Cost of Illness; D003362:Cost-Benefit Analysis; D005260:Female; D016330:Frail Elderly; D015577:Geriatric Assessment; D006299:Health Services for the Aged / Q000191:economics*; D006801:Humans; D008297:Male; D009426:Netherlands; D010043:Outcome and Process Assessment, Health Care; D011320:Primary Health Care / Q000191:economics / Q000379:methods*; D015397:Program Evaluation; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D012044:Regression Analysis