Designing Pilot Studies for Embedded Pragmatic Clinical Trials

September 22, 2026

A new article by IMPACT Collaboratory members Susan L. Mitchell, MD, MPH; Vincent Mor, PhD; Heather G. Allore, PhD; Thomas G. Travison, PhD; Ellen P. McCarthy, PhD, MPH; Kathleen T. Unroe, MD, MHA; Joseph E. Gaugler, PhD; Jill Harrison, PhD; and Abraham A. Brody, PhD, RN, offers practical guidance for designing pilot embedded pragmatic clinical trials (ePCTs) in dementia care.

The authors draw on experience from the IMPACT Collaboratory’s Pilot Grant Program, which supported 23 pilot ePCTs during the Collaboratory’s first five years. The article summarize key considerations for designing and conducting pilot ePCTs, drawing on lessons from traditional pilot randomized controlled trials, the unique features of pragmatic trials embedded in health care systems, and the IMPACT Collaboratory’s experience supporting dementia care research. The resulting guidance is intended to help investigators generate the information needed to determine whether—and how—a larger ePCT should proceed.