title: Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT).
abstract: BACKGROUND
  Currently, primary care for frail older people is reactive, time consuming and does not meet patients' needs. A transition is needed towards proactive and integrated care, so that daily functioning and a good quality of life can be preserved. To work towards these goals, two interventions were developed to enhance the care of frail older patients in general practice: a screening and monitoring intervention using routine healthcare data (U-PRIM) and a nurse-led multidisciplinary intervention program (U-CARE). The U-PROFIT trial was designed to evaluate the effectiveness of these interventions. The aim of this paper is to describe the U-PROFIT trial design and to discuss methodological issues and challenges.
  
  
  METHODS
  The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate. The primary outcome is the effect on activities of daily living as measured with the Katz ADL index. Secondary outcomes are quality of life, mortality, nursing home admission, emergency department and out-of-hours General Practice (GP), surgery visits, and caregiver burden.
  
  
  CONCLUSIONS
  In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur. Recruitment and retention of patients and feasibility of the interventions are important issues. To enable broad generalizability of results, careful choices of the design and outcome measures are required. Taking this into account, the U-PROFIT trial aims to provide robust evidence for a structured and integrated approach to provide care for frail older people in primary care.
  
  
  BACKGROUND
  NTR2288.
authors.affiliation: Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Universiteitsweg 100, Utrecht CG 3584, The Netherlands. N.Bleijenberg@umcutrecht.nl
authors.forename: Nienke
authors.initials: N
authors.lastname: Bleijenberg
authors.forename: Irene
authors.initials: I
authors.lastname: Drubbel
authors.forename: Valerie H
authors.initials: VH
authors.lastname: Ten Dam
authors.forename: Mattijs E
authors.initials: ME
authors.lastname: Numans
authors.forename: Marieke J
authors.initials: MJ
authors.lastname: Schuurmans
authors.forename: Niek J
authors.initials: NJ
authors.lastname: de Wit
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019033:Delivery of Health Care, Integrated / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D016330:Frail Elderly / Q000523:psychology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011320:Primary Health Care / Q000379:methods*; D012307:Risk Factors; D016037:Single-Blind Method; D011795:Surveys and Questionnaires