43COMPREHENSIVE GERIATRIC ASSESSMENT IN HOSPITAL OR AT HOME? THE ROLE OF CLINICIAN UNCERTAINTY IN RECRUITMENT TO A RANDOMISED CONTROLLED TRIAL

Abstract

Introduction: Ethical recruitment of patients to a clinical trial assumes uncertainty about advantages and disadvantages of the treatment modalities, or 'equipoise'. This study considers the concept of uncertainty in a multicentre randomised controlled trial (RCT) of a complex intervention: Comprehensive Geriatric Assessment (CGA) in a hospital or hospital at home (HAH) setting. We aimed to identify factors influencing recruitment, which may ultimately affect trial success. Methods: We used mixed methods in an explanatory sequential design: (1) quantitative data collection from screening logs, for cross‐site comparison of enrolment outcomes and documented reasons for exclusion of eligible patients, and (2) qualitative discussions with a purposive sample of research coordinators, clinicians and principle investigators across sites, to explore perspectives and issues arising during screening and recruitment. Results: Data were collated for a total of 2325 patients documented as potentially eligible across seven RCT sites over a period of 20 months, of whom 883 patients were recruited to the trial (37.98% of those documented to be potentially eligible). Recorded reasons for non‐recruitment varied across the sites, however higher rates of non‐recruitment of potentially eligible patients appeared to be associated with higher proportions of clinicianled reasons for exclusion. Through preliminary content analysis of qualitative data, we have identified: (1) caution expressed by clinicians regarding research engagement; (2) clinicians' preferences vary according to the service in which recruitment decisions are made; and (3) personal experience of HAH services influences perceptions of the RCT and clinicians' engagement with recruitment. Conclusions: Our preliminary findings indicate that perceptions of local services shape individual clinicians' preferences and diminish the uncertainty in decision‐making that supports RCT recruitment. Further analysis will explore additional factors affecting clinician engagement with this research, and effects of patients' expressed preferences when invited to participate.