Pragmatic clinical trials embedded in healthcare systems rely on partnerships between investigators and healthcare system leaders to conduct research. As the end of a pragmatic trial approaches, research teams and their partners often face uncertainties around this undefined phase when researchers are waiting on results. End-of-trial decision-making, including whether to sustain an intervention, has implications for research teams, healthcare systems, and patients.
A new chapter of the Living Textbook of Pragmatic Clinical Trials, published this week, describes the challenges investigators face during this common period of ambiguity and offers considerations for decision-making that honors researchers’ responsibilities and fosters ongoing collaboration with healthcare system partners while awaiting trial results:
- Section 1 introduces possible trial outcomes and describes the intersection of posttrial responsibilities, sustainment, and deimplementation.
- Section 2 provides case studies describing how research teams from 3 NIH Collaboratory Trials approached end-of-trial decision-making.
- Section 3 focuses on considerations for investigators and an end-of-trial decision-making framework.
- Section 4 provides approaches that investigators might take to support research teams and healthcare system partners as they navigate the last part of a trial, before outcomes are known.
The chapter was developed by members of the NIH Pragmatic Trials Collaboratory’s Health Care Systems Interactions Core.
The 
Gregory Simon, MD, MPH
Anne Trontell, MD, MPH
Steven George, PhD
