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  • Title: Recruiting general practitioners and older patients with multimorbidity to randomized trials.
    Author: McCarthy C, Pericin I, Smith SM, Moriarty F, Clyne B.
    Journal: Fam Pract; 2023 Dec 22; 40(5-6):810-819. PubMed ID: 37014975.
    Abstract:
    BACKGROUND: Older patients with multimorbidity are under-represented in experimental research. OBJECTIVE: To explore the barriers and facilitators to general practitioner (GP) and older patient recruitment and retention in a cluster randomized controlled trial (RCT). METHOD: This descriptive study uses qualitative and quantitative data from a cluster RCT, designed to evaluate the effectiveness of a medicines optimization intervention. The SPPiRE cluster RCT enrolled 51 general practices and 404 patients aged ≥65 years and prescribed ≥15 medicines. Quantitative data were collected from all recruited practices and 32 additional practices who were enrolled, but unable to recruit sufficient participants. Qualitative data were collected from purposive samples of intervention GPs (18/26), patients (27/208), and researcher logs and analysed thematically using inductive coding. RESULTS: Enrolment rates for practices and patients were 37% and 25%, respectively. Barriers to GP recruitment were lack of resources and to patient recruitment were difficulty understanding trial material and concern about medicines being taken away. GPs' primary motivation was perceived importance of the research question, whereas patients' primary motivation was trust in their GP. All general practices were retained. Thirty-five patients (8.6%) were lost to follow-up for primary outcomes, mainly because they had died and 45% did not return patient-reported outcome measures (PROMs). CONCLUSION: Patient retention for the primary outcome was high, as it was collected directly from patient records. Patient completion of PROM data was poor, reflecting difficulty in understanding trial material. Recruiting older patients with multimorbidity to clinical trials is possible but requires significant resource and planning. TRIAL REGISTRATION: ISRCTN Registry ISRCTN12752680. Randomized controlled trials (RCTs) often exclude older people with multiple medical conditions. The aim of this study was to explore how and why participants took part in a primary care based RCT that included 51 general practitioners (GPs) and 404 older patients prescribed ≥15 medicines. The RCT was designed to assess the usefulness of a supported medication review. The study team assessed information that was already collected as part of the RCT, to describe the process of inviting and enrolling GPs and older people. This included information on the numbers invited and enrolled and interviews from a smaller sample of GPs (18) and older people (27). The study successfully enrolled the required number of participants but it took 26 months more than planned. 37% of invited GPs and 25% of invited patients took part. GPs felt the research was important but they identified lack of time and resources as barriers to participation. Older people predominantly took part because they trusted their GP but some were wary of having medicines taken away and were put off by trial documentation. It is important that RCTs including older people with multiple medical conditions carefully plan recruitment and pay careful attention to trial documentation.
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