Abstract

Objective. The objective of this project was to determine how investigators conduct clinical trials in the prehospital setting and to suggest how emergency medical services (EMS) systems can develop the capacity to conduct prehospital clinical research. Methods. A representative sample of U.S.-based study sites was selected from all studies registered on clinicaltrials.gov since the year 2000, where prehospital care providers conducted study-related activities in the prehospital setting. The site principal investigator and the research coordinator or EMS liaison were invited to participate in a structured discussion. A single interviewer conducted each discussion following a structured guide that generically asked for barriers and enablers to the sites’ research success and then reviewed commonly identified prehospital research barriers. Notes were taken during each discussion and reviewed for common themes. Themes were reviewed by the project team and sent for comment to all participants. Results. Discussions were held with 25 principal investigators, 9 coordinators, and 7 EMS liaisons. A total of 27 communities were represented in the discussions from 22 different states. The communities had a range of research experience from one prehospital trial to multiple trials. Key barriers were funding, ethics approval, data collection, protocol training and compliance, randomizing and blinding interventions, obtaining patient outcomes, adequate study staffing, and partnering with EMS agencies. Conclusion. This project identified many challenges to EMS research, but they were not insurmountable. Not every community can conduct every prehospital study. Communities should engage in studies that align with their values and resources. Investigators need to develop honest relationships where issues can be openly discussed and the community can collaborate on prehospital research. Learning from those who have overcome challenges may be a key to expanding the quality and quantity of EMS research.

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