Pragmatic clinical trials are conducted as part of routine healthcare delivery and often compare an intervention to usual care. To do this, researchers must understand, monitor, and document standard care at participating research sites.
At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Duke University’s Emily O’Brian asked a panel of trialists about the strategies they used to define and document usual care. The panelists included Rachel Winer, co–principal investigator (PI) of STEP-2;, Richard Platt, co-PI of INSPIRE; and Christine Goertz, co-PI of IMPACt-LBP.
Key Strategies
- Establish a community of individuals who are interested in and committed to answering the research question
- Develop relationships: visit each site and have monthly coaching calls
- Get commitment in advance from sites to hold their practice constant for the duration of the trial
- Have sites complete readiness surveys or feasibility assessments that include questions about potential upcoming quality improvement initiatives
- Minimize burden on sites as much as possible
The Navigating the Unknown chapter of the Living Textbook includes descriptions of unanticipated challenges that may occur during the years-long course of a study that can have profound effects on usual care, including:
- Staff Turnover, Leadership Changes, and Health System Acquisition and Mergers
- Impact of Electronic Health Record Updates and Changes
- Impact of COVID-19
- Challenges Related to Recruitment and Implementation
- Responding to Guideline and Policy Changes That Affect Ongoing ePCTs
- Accounting for Quality Improvement During ePCTs
These challenges all require close collaboration with research partners to develop solutions.
This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.