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

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. Methods: Semi-structured interviews were conducted with 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 reported included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule (COM-B Physical and Social Opportunities, TDF Environmental Context & Resources and Social Influences), 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 trial design, set-up, and conduct (TDF Environmental Context & Resources). Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation (COM-B Reflective Motivation and TDF Beliefs about consequences). 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.