Designing Pilot Studies for Embedded Pragmatic Clinical Trials.

AbstractEmbedded pragmatic clinical trials (ePCTs) conducted in health care systems are designed to test the effectiveness of interventions under real-world conditions and accelerate their adoption into clinical practice. ePCTs have distinct features compared with traditional randomized controlled trials, and investigators are still gaining experience designing and conducting them. Poorly executed ePCTs lead to invalid results, wasted resources, reluctance of health care systems to partner in research, and delays translating effective care into practice. Demonstrating ePCTs are feasible before embarking on them is essential. The National Institute on Aging IMbedded Pragmatic Alzheimer's Disease (AD) and AD-Related Dementias Clinical Trials (IMPACT) Collaboratory was established in 2019 to build national capacity to conduct ePCTs in dementia care. Over 5 years, IMPACT funded 23 pilot ePCTs. Drawing on that experience, this Clinical Trials Workshop reviews a practical approach for designing pilot ePCTs.