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Abstract Background Trials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this setting. Previous studies have assessed challenges reported in individual trials rather than across the pre-hospital trial landscape to identify over-arching factors. The aim of this study was to investigate the challenges and opportunities related to the set-up, design and conduct of pre-hospital trauma trials from across the pre-hospital trial landscape and a specific pre-hospital trauma feasibility study. Methods Semi-structured interviews were conducted with two cohorts of participants: research personnel who had experience of pre-hospital trials, either through direct involvement in conduct or through strategic oversight of national initiatives (n = 7), and clinical staff (n = 16) involved in recruitment to a pre-hospital trauma feasibility study. Thematic analyses were used to assess the barriers and enablers of conducting pre-hospital trauma trials. Two frameworks (The Capability Opportunity Motivation—Behaviour and the Theoretical Domains Framework) were used to guide analyses. Results The barriers and enablers reported were relevant to several TDF domains and COM-B components. Across both cohorts, challenges associated with opportunities were reported and included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule, and the involvement of external organisations with diverse institutional priorities and infrastructures (e.g. Air Ambulances). The infrequency of eligible cases was also reported to affect the trial design, set-up, and conduct. Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation. Conclusions This study has highlighted that pre-hospital trials face many context-specific but also generic challenges. Pre-hospital trauma trial teams could consider the findings to develop targeted, behaviourally focused, solutions to the challenges identified in order to enhance the set-up and conduct of trials in this setting. Trial registration NCT04145271. Trial registration date: October 30, 2019. Note that this paper does not report results from a specific trial but does include participants who were involved in the conduct of a registered pre-hospital feasibility study.

Abstract Background The evidence on what strategies can improve recruitment to clinical trials in maternity care is lacking. As trial recruiters, maternity healthcare professionals (MHCPs) perform behaviours (e.g. talking about trials with potential participants, distributing trial information) they may not ordinarily do outside of the trial. Most trial recruitment interventions do not provide any theoretical basis for the potential effect (on behaviour) or describe if stakeholders were involved during development. The study aim was to use behavioural theory in a co-design process to develop an intervention for MHCPs tasked with approaching all eligible potential participants and inviting them to join a maternity trial and to assess the acceptability and feasibility of such an intervention. Methods This study applied a step-wise sequential mixed-methods approach. Key stages were informed by the Theoretical Domains Framework and Behaviour Change Techniques (BCT) Taxonomy to map the accounts of MHCPs, with regard to challenges to trial recruitment, to theoretically informed behaviour change strategies. Our recruitment intervention was co-designed during workshops with MHCPs and maternity service users. Acceptability and feasibility of our intervention was assessed using an online questionnaire based on the Theoretical Framework of Acceptability (TFA) and involved a range of trial stakeholders. Results Two co-design workshops, with a total of nine participants (n = 7 MHCP, n = 2 maternity service users), discussed thirteen BCTs as potential solutions. Ten BCTs, broadly covering Consequences and Reframing, progressed to intervention development. Forty-five trial stakeholders (clinical midwives, research midwives/nurses, doctors, allied health professionals and trial team members) participated in the online TFA questionnaire. The intervention was perceived effective, coherent, and not burdensome to engage with. Core areas for future refinement included Anticipated opportunity and Self-efficacy. Conclusion We developed a behaviour change recruitment intervention which is based on the accounts of MHCP trial recruiters and developed in a co-design process. Overall, the intervention was deemed acceptable. Future evaluation of the intervention will establish its effectiveness in enabling MHCPs to invite all eligible people to participate in a maternity care trial, and determine whether this translates into an increase in maternity trial recruitment rates.

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