At the NIH Pragmatic Trials Collaboratory’s 2025 Annual Steering Committee Meeting, Angelo Volandes, co–principal investigator (PI) of the ACP PEACE trial, led a panel of investigators who shared key challenges and lessons learned from their recently launched trials. The panelists included Stephanie Fitzpatrick, PI of the MOMs Chat & Care Study, Elizabeth Wick, co-PI of I CAN Do Surgical ACP, and ChenChen Wang and Robert Saper, co-PIs of TAICHIKNEE.
MOMs Chat & Care Study
Goal: To test the effectiveness of Northwell Health’s MOMs navigation program at 2 levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Latina birthing people and reduce risk for severe maternal morbidity
Key Challenge: Low recruitment
Solutions:
- Expanded inclusion criteria to include Hispanic/Latina patients, those with lower risk factor scores, and gestational of less than 17 weeks instead of less than 13 weeks
- Added manual review of charts to ensure the patients they telephoned for recruitment are pregnant and to determine the number of weeks of pregnancy
- Changed recruitment materials and general approach so that empathy is at the forefront
Learn more about the MOMs Chat & Care Study.
I CAN DO Surgical ACP
Goal: To identify a systems-based approach to help older adults undergoing major elective surgery engage in advance care planning decisions
Key Challenge: One site will finish 6 months early but will still have access to the platform for research, which provides an opportunity they do not want to waste
Solution: Use the trial infrastructure to pilot test another intervention in the remaining months of trial time. The plan is to develop and test human-in-the-loop patient-facing generative AI to assess the quality of patient–AI interactions and answer additional questions, potentially laying the groundwork for future trials.
Learn more about I CAN DO Surgical ACP.
TAICHIKNEE
Goal: To determine whether remotely delivered tai chi is feasible across the 4 partnering healthcare systems and if tai chi, compared with routine care, will improve physical health (including knee pain and function), mental health, and healthcare utilization
Key Challenge: Long delays at institutional review board due to backlogs
Solution: The PI understood that many organizations had to cut costs and reduce IRB and regulatory staff, which likely drove delays in regulatory approval. When the study leadership interacted with the IRB, they did so in a generous and curious way, asking how they could help. The regulatory staff acknowledged the problem and suggested that, as the trial is federally funded and meets the regulatory criteria to be considered minimal risk, it should take priority.
This summer, we are sharing highlights from the 2025 Annual Steering Committee Meeting. Access the complete collection of meeting materials.