Investigators planning emergency department (ED)­–based pragmatic clinical trials (PCTs) face multiple decisions during the planning phase to ensure robust and meaningful study findings in this unique setting; however, there is no guide for planning and conducting these studies.

A new article in Academic Emergency Medicine fills the gap by providing recommendations for the design of PCTs in emergency settings. Among the authors are investigators from EMBED and PRIM-ER, both NIH Pragmatic Trials Collaboratory Trials.

The authors recommend that investigators planning ED-based PCTs should strongly consider the use of the PRECIS-2 wheel diagram during the study design phase to increase chances that the results of the trial are generalizable across the intended practice settings. The PRECIS tool was developed to help investigators work through study design decisions to avoid designing a trial that does not meet their own intentions.

The authors expand upon the 9 domains within the PRECIS-2 framework to identify points for investigators to consider in the design of ED-based PCTs, and they provide examples of successful studies. Using the PRECIS-2 framework can help investigators navigate unique challenges in the ED setting, including time-sensitive conditions, limited availability of electronic health data for the patient population, and added complexity surrounding capacity and consent for certain vulnerable ED populations with mental illness or substance use disorder.

The authors also address special considerations for randomization, human subjects concerns, and electronic health record integration.

Finally, the authors provide an analysis that highlights the advantages, disadvantages, and rationale for the use of 4 common randomized PCT study design types and examples of similar trials set in the ED.

Read the full text of the article.