Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT)

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.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.NTR2288With an increasing number of older people in society, the number of frail older people with complex care needs will rise [1]. Frailty is a term often used among health care professionals to characterize older people who have a functional loss of resources in different domains. Frail older people have an increased risk for adverse health outcomes, such as mortality, morbidity and institutionalization [2-5]. The increasing number of frail older people will seriously challenge the health care system because primary care for these patients is currently fragmented, time consuming and reactive [6]. Because the care system does not address their needs, many older patients and their caregivers have a poor quality of life [7,8]. To preserve functional performance and maintain independent living in this vulnerable population, a transition is needed towards more proactive, integrated and structured health care for older people.Until today, scientific evidence on how primary c