Abstract
BackgroundCurrently, 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/DesignThe 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.DiscussionIn 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.Trial registrationNTR2288
Highlights
Primary care for frail older people is reactive, time consuming and does not meet patients’ needs
In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur
Participants Inclusion criteria Selection of patients is performed by the Utrecht Periodic Risk Identification and Monitoring system (U-PRIM) system, a software application that is installed in all participating general practices
Summary
We present the research design and methodology of the U-PROFIT trial. This trial assesses the effectiveness of two interventions: a proactive screening and monitoring system and a nurse-led intervention program. With different deficit content and considering different numbers of deficits, yield closely related results [25] In this trial, we aim to demonstrate that the frailty index can be used for structured risk assessment in primary care practice, using routine care data. Various challenges have to be addressed, the U-PROFIT trial offers excellent opportunities for a valid scientific evaluation of a structured and integrated approach to improve physical functioning in frail older people in primary care. Once proven effective, it can be broadly implemented in daily clinical practice. Additional file 3: Overview of health problems, assessments and summary of interventions
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