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 for 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 investigation (‘diagnosis’) was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, 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-making 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 (‘diagnose’) behavioural trial process problems and subsequently develop and implement targeted solutions (‘treatment’) in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices. Trial registration ISRCTN 16,184,981

Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation

“…We used behavioural frameworks (COM-B and TDF) to facilitate our understanding of the barriers and enablers to conducting pre-hospital trials. Although this approach is gaining traction in the field of trial methodology [15,16,[29][30][31][32][33][34][35], few studies have applied behavioural approaches to understand trial challenges within a prehospital context. In a clinical care pre-hospital setting, an interview study used the TDF to explore the factors that influence paramedics' administration of tranexamic acid [36].…”

Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation

“…We used behavioural frameworks (COM-B and TDF) to facilitate our understanding of the barriers and enablers to conducting pre-hospital trials. Although this approach is gaining traction in the eld of trials methodology (10)(11)(12)(13)(27)(28)(29)(30), few studies have applied behavioural approaches to understand trial challenges within a pre-hospital context. In a clinical care pre-hospital setting, an interview study used the TDF to explore the factors that in uence paramedics' administration of tranexamic acid (31).…”