• Emerg Med J · Aug 2016

    Randomized Controlled Trial

    Human factors in prehospital research: lessons from the PARAMEDIC trial.

    • Helen Pocock, Charles D Deakin, Tom Quinn, Gavin D Perkins, Jessica Horton, and Simon Gates.
    • South Central Ambulance Service NHS Foundation Trust, Otterbourne, UK.
    • Emerg Med J. 2016 Aug 1; 33 (8): 562-8.

    BackgroundThere is an urgent need to develop prehospital research capability in order to improve the care of patients presenting to emergency medical services (EMS). The Prehospital Randomised Assessment of a Mechanical compression Device In Cardiac arrest trial, a pragmatic cluster randomised trial evaluating the LUCAS-2 device, represents the largest randomised controlled trial conducted by UK ambulance services to date. The aim of this study was to identify and analyse factors that may influence paramedic attitudes to, and participation in, clinical trials.MethodsPersonal and organisational experience from this trial was assessed by feedback from a workshop attended by collaborators from participating EMS and a survey of EMS personnel participating in the trial. A work systems model was used to explain the impact of five interwoven themes-person, organisation, tasks, tools & technology and environment-on trial conduct including gathering of high-quality data.ResultsThe challenge of training a geographically diverse EMS workforce required development of multiple educational solutions. In order to operationalise the trial protocol, internal organisational relationships were perceived as essential. Staff perceptions of the normalisation of participation and ownership of the trial influenced protocol compliance rates. Undertaking research was considered less burdensome when additional tasks were minimised and more difficult when equipment was unavailable. The prehospital environment presents practical challenges for undertaking clinical trials, but our experience suggests these are not insurmountable and should not preclude conducting high-quality research in this setting.ConclusionsApplication of a human factors model to the implementation of a clinical trial protocol has improved understanding of the work system, which can inform the future conduct of clinical trials and foster a research culture within UK ambulance services.Trial Registration NumberISRCTN08233942.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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