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)
February 20, 2023: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the Health Care Systems Research Network 2023 Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory 
This virtual workshop introduced concepts in the design, conduct, and implementation of ePCTs, with a particular focus on methods relevant to health services researchers. The workshop provided a greater understanding of the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the Collaboratory Demonstration Projects illustrated the topics presented.