April 2022 Steering Committee Meeting

Steering Committee Meeting

April 20-21, 2022

Bethesda, MD

Main Purpose

Celebrate 10 years of the Collaboratory program with discussions on the evolution and current landscape of embedded pragmatic clinical trials (ePCTs); share thoughts on priorities for the future of ePCTs, including how to better serve diverse populations; hear updates on progress and transition plans, as well as challenges and lessons learned, from the UG3 NIH Collaboratory Trials; and learn about the latest bioethics activities in the NIH Collaboratory.

Wednesday, April 20, 2022

Welcome and Opening Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Keynote Panel

Celebrate the success of the Collaboratory and describe the roadmap for its future

Moderator: Josie Briggs, MD

  • Cathy Meyers, MD
  • Wendy Weber, ND, PhD, MPH

Then, Now, and the Future…

Moderator: Adrian Hernandez, MD, MHS

The NIH's perspective on how the Collaboratory has propelled embedded pragmatic research throughout the NIH

This panel of contributors from throughout the Collaboratory's history will discuss the program's influence on the evolution of ePCTs over the past decade, including methodologic advances, surprising takeaways, and best practices generated from supporting over 20 large-scale trials within health systems.

Looking at the Landscape of National ePCT Initiatives

Presentations on lessons learned from the Collaboratory and the work of other ongoing pragmatic trial programs

Navigating the Challenges of Including Diverse Participants

Panel discussion questions:
1. Are ePCTs answering questions that are high priority for health systems that serve diverse patient populations?
2. How can we build capacity and infrastructure across institutions with fewer resources?
3. How do we develop a pipeline of diverse investigators across diverse sites?

Moderator: Rosa Gonzalez-Guarda, PhD, MPH, RN, CPH, FAAN

  • Karen Kehl, PhD, RN, FPCN
  • Rachel Gold, PhD, MPH
  • Julie Fritz, PhD, PT
  • Natalia Morone, MD
  • Mitch Knisely, PhD, RN-BC, ACNS-BC
  • Gloria Coronado, PhD

Discussion From New UG3 NIH Collaboratory Trial: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP)

Update on lessons learned from Year 1, ongoing transition issues, sustainability for the UH3 phase, and any challenges. Discuss the UG3’s current data sharing plans.

Christine Goertz, DC, PhD; Adam Goode, PT, DPT, PhD; Jon Lurie, MD, MS; Hrishikesh Chakraborty, DrPH

Closing Remarks/Adjourn

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

10th Anniversary Celebration

Highlights slides

Posters

 

Thursday, April 21, 2022

Welcome and Opening Remarks

Helene Langevin, MD, PhD; David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD

Perspectives From Our Federal Partners

U.S. Food and Drug Administration

Discuss how to generate evidence at a very large scale, especially for chronic health conditions like pain management

  • Rob Califf, MD

Centers for Medicare & Medicaid Services

  • Lee Fleisher, MD

HHS OS-Patient-Centered Outcomes Research Trust Fund

Share projects that may be of interest to Collaboratory investigators such as data linkages and social determinants of health data

  • Nancy DeLew, MA, MPA

Unanticipated Challenges

The NIH Collaboratory Trials on this panel encountered unanticipated challenges that caused them to change the randomization scheme of their trial. With the help of the Biostatistics and Study Design Core, we will explore the challenges, solutions, and lessons learned as part of this process.

Moderators: Patrick Heagerty, PhD; David Murray, PhD

Barriers and Challenges: Patient, Clinician, and Healthcare System Engagement

Of all the activities in ePCTs, patient, clinician, and healthcare system engagement is continuously ranked one of the most challenging by NIH Collaboratory Trials. Enrollment and engagement of participants is hard, as is engaging with clinicians, providers, and healthcare systems’ leaders throughout the life cycle of a study. We will discuss challenges encountered and solutions for engaging stakeholders to ensure a successful trial.

Moderator: Eric Larson, MD, MPH

Barriers and Challenges: Data Collection and Merging Data Sets

Collecting and aggregating data from diverse data sets, including the electronic health record, patient-report outcomes, and claims data, involves many expected and unexpected challenges. We will learn about the data-related barriers encountered by NIH Collaboratory Trials, their solutions, and their suggestions for future trials.

Moderator: Keith Marsolo, PhD

Barriers and Challenges: Implementing/Delivering Interventions Across Healthcare Organizations and Stability of Control

Successfully implementing and delivering an intervention across multiple organizations is dependent on many factors, including the complexity of the intervention, the stability of the control, and barriers to and promoters of uptake. We will learn from the NIH Collaboratory Trials’ experiences with implementation.

Moderator: Steven George, PhD

  • PRIM-ER: Corita Grudzen, MD, MSHS, FACEP
  • GRACE: Mitch Knisely, PhD, RN-BC, ACNS-BC
  • ACP PEACE: James Tulsky, MD
  • BackInAction: Karen Sherman, PhD, MPH

Bioethics Supplement Activities

An update on the activities of the Bioethics Supplement

Stephanie Morain, PhD

Closing Remarks

Helene Langevin, MD, PhD; Richard Hodes, MD; Lesley Curtis, PhD

NIH-Hosted Workshop: Critical Questions for Pragmatic Clinical Trialists: Insights From the NIH Pragmatic Trials Collaboratory’s First Decade

This 2-day workshop held during June 2022 is an opportunity to glean the most salient lessons learned from an experienced group of pragmatic trial investigators who openly shared the challenges they have encountered, solutions they have developed, and thoughts for the future. 

Citation:

April 2022 Steering Committee Meeting: April 2022 Steering Committee Meeting. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/april-2022-steering-committee-meeting/. Updated March 19, 2026.