June 23-24, 2023: This workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials, with a focus on methods relevant to health services researchers, while providing firsthand experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.
Agenda and Slides
Day 1: June 23
Welcome and Opening Remarks
Kevin Weinfurt, PhD
Session 1: What are Embedded Pragmatic Clinical Trials (ePCTs)?
Wendy Weber, ND, PhD, MPH
Session 2: Engaging Stakeholders and Aligning With Health System Partners
Emily O’Brien, PhD
Session 3: Objectives and Trial Design: An Overview of Hybrid Designs
Hayden Bosworth, PhD
Session 4: Measuring Outcomes
Emily O’Brien, PhD
Session 5: ePCT Design
Patrick Heagerty, PhD
Session 6: ePCT Analysis
Patrick Heagerty, PhD
Session 7: ePCTs in Context: Small Group Work Followed by Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Kevin Weinfurt, PhD
Panel: Margaret Kuklinski, PhD; Angelo Volandes, MD; Michael Parchman, MD
Closing Remarks
Kevin Weinfurt, PhD
Day 2: June 24
Welcome and Opening Remarks
Kevin Weinfurt, PhD
Session 8: Pilot and Feasibility Testing
Wendy Weber, ND, PhD, MPH
Session 9: Ethical and Regulatory Oversight Considerations
Stephanie Morain, PhD, MPH
Session 10: Writing a Compelling Grant Application
Beda Jean-Francois, PhD
Session 11: ePCTs in Context: Small Group Work Followed by Panel Discussion With NIH Collaboratory Trials PIs
Moderator: Vince Mor, PhD
Panel: Margaret Kuklinski, PhD; Ardith Doorenbos, Phd
Closing Remarks
Kevin Weinfurt, PhD
Case Studies
Examples from NIH Collaboratory Trials:
- ACP PEACE: Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (Angelo Volandes, MD)
- GGC4H: Testing Feasibility and Effectiveness of Universal Parent-Focused Prevention in Three Healthcare Systems (Margaret Kuklinski, PhD)
- GRACE: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (Ardith Doorenbos, PhD)
- Can Value Champions Reduce Inappropriate Prescribing for People with Dementia? (Michael Parchman, MD)