December 13, 2021: The NIH Pragmatic Trials Collaboratory and the NIA IMPACT Collaboratory co-hosted a Pre-Conference Workshop for AcademyHealth’s Annual Conference on the Science of Dissemination & Implementation (D&I) in Health. This training workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), with a particular focus on the intersection between ePCTs and implementation research methods. The workshop provided an introduction to the investigative opportunities for embedded health systems research, along with strategies for integrating implementation research methods in the design and conduct of ePCTs with the goal of providing real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Health Care Systems Research Collaboratory and the NIA IMPACT ADRD Collaboratory supported and illustrated the topics presented.
Agenda and Slides
Welcome and Introduction
Wendy Weber, ND, PhD, MPH
Session 1: What Are Embedded Pragmatic Clinical Trials (ePCTs) and How Do They Intersect with D&I Research?
Wendy Weber, ND, PhD, MPH
Session 2: Stakeholder Engagement and Planning for D&I From the Beginning
Devon Check, PhD
Case Study Presentations
Moderator: Kevin Weinfurt, PhD
- PROVEN: PRagmatic trial Of Video Education in Nursing Homes (PROVEN) (Vince Mor, PhD)
- ALIGN: Aligning Medications with What Matters Most (ALIGN) (Ariel Green, PhD)
- HAS-QOL: The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (Ab Brody, PhD)
Session 3: Integrating D&I Into ePCT Study Designs & Analysis
An Overview of Hybrid Designs
Geoff Curran, PhD
Case Study Presentations
Moderator: Devon Check, PhD
- Music & MEmory: A Pragmatic TRial for Nursing Home Residents With ALzheimer's Disease_part1 (METRIcAL) (Ellen McCreedy, MhD)
- Integrating D&I Into ePCT Study Designs & Analysis (Patrick Heagerty, PhD)
Session 4: Additional Considerations When Conducting ePCTS
Ethical and Regulatory Considerations
Stephanie Morain, PhD
Pilot and Feasibility Testing
Wendy Weber, ND, PhD, MPH
A Framework for Achieving Health Equity in Pragmatic Trials
Jonathan Jackson, PhD
Case Study Presentations
Moderator: Vince Mor, PhD
- Pilot Pragmatic Clinical Trial to Embed Tele-Savvy into Health Care Systems (Richard Fortinsky, PhD)
- ADVANCE-PC: Testing Critical Components for a Trial of Advance Care Planning in Primary Care for Dementia (Annette Totten, PhD)
Closing Remarks
David Chambers. PhD