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.