A new approach to hosting pre-hospital clinical trials: Developing research governance awareness

Development of new evidence to support pre-hospital emergency care benefits both patients and practitioners. However clinical research must be conducted within a formal governance framework and this represents a challenge for ambulance service personnel as high service demands restrict access to traditional Good Clinical Practice (GCP) training some content of which is also of little relevance to the pre-hospital setting.  Through a structured process of literature review, stakeholder engagement and expert consensus this project has developed training and assessment materials which can be used flexibly to prepare paramedics and the wider ambulance workforce for safe hosting of low-risk research activities.

The aim of the programme of work for this project was to create easily accessible training materials to prepare paramedics and the wider ambulance workforce for safe hosting of low-risk research activities.

Contact Details

  • Sonia Byers, Research and Development Manager, North East Ambulance Service NHS Foundation Trust
  • [email protected]

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It will be fantastic to have an easily accessible resource tailored to pre-hospital clinicians.
Kim Kirby, Research Paramedic, South Western Ambulance Service NHS Foundation Trust
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Increasing EMS clinical research activity is recognised as a national priority but pre-hospital barriers include time pressures, service demands and traditional professional boundaries. Training will assist with the latter but this is challenging for two main issues. The first is shift-based service delivery, which makes scheduling conventional face-to-face training sessions difficult, especially across large geographical areas. The second is traditional use of standard GCP materials, which do not take into account the nature of pre-hospital research roles and evolving study designs. To help overcome these, we aimed to create specific training materials for paramedics and other ambulance personnel which could be delivered face-to-face or electronically. Through doing so, concerns that education and training for paramedics lacks a standardised approach have been addressed.

  • Standardised research governance awareness training materials for use by all UK NHS paramedics and other ambulance personnel are now freely available online at: http://tinyurl.com/gcp4para. The content and delivery of these has not previously been tailored to the roles of paramedics or the emerging designs used by pre-hospital studies.
  • Standardised assessment tool comprising twelve multiple choice questions (MCQs) is also freely available online at: http://tinyurl.com/gcp4para. Successful completion of which permits a certificate to be obtained for continuous professional development purposes and to provide evidence of GCP awareness for clinical trial purposes without impacting on either personal or professional time constraints.

Systematic review:  1907 journal abstracts identified which fulfilled eligibility criteria. However, only 28 full text articles referred to some aspect of the research protocol, 3 of which implicated GCP but no content was available. As this review failed to identify a benchmark for pre-hospital research governance preparation the materials relating to one of those studies which implicated GCP were developed to form the basis for the consensus exercise.

Stakeholder engagement: An online survey was conducted across ambulance trusts between January and March 2015 in order to determine NHS paramedics’ experiences of clinical research training. The results (n=120) indicated that training to prepare paramedics for a role in clinical research was inconsistent. Only one in eight respondents had received GCP training.

Expert consensus exercise: A two round Delphi – style exercise conducted with a panel comprising seventeen members sourced from ambulance trust research leads, senior paramedics, university academics and GCP trainers led to a set of 32 slides covering the core principles of GCP including informed consent, circumstances relevant to research in the pre-hospital environment, safety reporting and the importance of clear documentation. The final slide provides the link to an online MCQ assessment module which was developed as part of this consensus exercise.

  • At least 80 people have now attempted the certification part of the GCP training (June 2016).
  • Two other ambulances service (minimum 500 paramedics each) have started to use the training on their induction for new staff (June 2016).
  • Materials disseminated via presentation at EMS 999 Forum on 1.3.16; publication in Journal of Paramedic Practice Volume 8 (3): 144-148; and poster presentation at COP national conference 8-9.3.16.
  • Paramedics and other ambulance service personnel benefit through easy access to research governance awareness training.
  • NHS ambulance services benefit from the increased preparedness of their personnel to assist with clinical research which carries minimal impact on service delivery.
  • Project sponsors and lead personnel benefit from the reliability of standardised awareness training.
  • Nationally, the Department of Health benefits from the removal of a prime obstacle (lack of GCP awareness) to help promote the growth of pre-hospital research.
"This resource will be invaluable for ambulance staff and services conducting or thinking of undertaking research"
Niro Siriwardena, Professor of Primary and Prehospital Health Care, University of Lincoln