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 t...

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Main Authors: Louisa Lawrie, Eilidh M. Duncan, Robert Lendrum, Victoria Lebrec, Katie Gillies
Format: Article
Language:English
Published: BMC 2023-03-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-023-07184-5
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author Louisa Lawrie
Eilidh M. Duncan
Robert Lendrum
Victoria Lebrec
Katie Gillies
author_facet Louisa Lawrie
Eilidh M. Duncan
Robert Lendrum
Victoria Lebrec
Katie Gillies
author_sort Louisa Lawrie
collection DOAJ
description 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.
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spelling doaj.art-73bea8055cf940aebd00366f212fa2132023-03-22T12:17:25ZengBMCTrials1745-62152023-03-0124111110.1186/s13063-023-07184-5Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigationLouisa Lawrie0Eilidh M. Duncan1Robert Lendrum2Victoria Lebrec3Katie Gillies4Health Services Research Unit, 3Rd Floor Health Sciences Building, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of AberdeenHealth Services Research Unit, 3Rd Floor Health Sciences Building, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of AberdeenBarts Health NHS Trust, Royal London Hospital, St. Bartholomew’s HospitalHealth Services Research Unit, 3Rd Floor Health Sciences Building, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of AberdeenHealth Services Research Unit, 3Rd Floor Health Sciences Building, Institute of Applied Health Sciences, School of Medicine, Medical Sciences and Nutrition, University of AberdeenAbstract 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.https://doi.org/10.1186/s13063-023-07184-5Trials methodologyFeasibilityBehavioural SciencePre-hospital
spellingShingle Louisa Lawrie
Eilidh M. Duncan
Robert Lendrum
Victoria Lebrec
Katie Gillies
Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
Trials
Trials methodology
Feasibility
Behavioural Science
Pre-hospital
title Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
title_full Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
title_fullStr Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
title_full_unstemmed Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
title_short Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation
title_sort challenges and opportunities for conducting pre hospital trauma trials a behavioural investigation
topic Trials methodology
Feasibility
Behavioural Science
Pre-hospital
url https://doi.org/10.1186/s13063-023-07184-5
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