Behavioural Optimisation To Address Trial Conduct Challenges: Case Study In The UK-REBOA Trial

Abstract Background: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies to effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems. Methods: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of Resuscitative Endovascular Balloon Occlusion of the Aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural diagnosis was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to investigate trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify salient domains, which were then mapped to techniques for behaviour change and developed into potential solutions.Results: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills; Environmental context and resources; Beliefs about capabilities; Beliefs about consequences; Social influences; and Memory, attention, and decision processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery. Conclusions: This study demonstrates the feasibility of applying a behavioural approach to investigate behavioural trial process problems and subsequently develop and implement targeted solutions in an active trauma trial. Understanding the underlying determinants that affected behaviour, attitudes and beliefs in this trauma trial provided an avenue to implement theoretically informed, evidence-based solutions designed to enhance trial practices. Trial registration: ISRCTN: 16184981.