May 2019 Steering Committee Meeting

Steering Committee Meeting

May 1-2, 2019
Bethesda, MD

Main Purpose

Day 1: Discuss progress and sustainability of the NIH Collaboratory, hear perspectives on the landscape of embedded PCTs (ePCTs) and the need for real-world evidence, hear about challenges and lessons learned from the UH3 Demonstration Projects, get updates on progress and transition plans from the UG3 Demonstration Projects, discuss data sharing policy and planning, and conduct one-on-one consultations with representatives from the Core Working Groups.

Day 2: Intensive workshop to start discussions on statistical issues with ePCTs.

Wednesday, May 1, 2019

Welcome, Opening Remarks, and Introduction

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

Keynote Panel

Perspectives on generating real-world evidence and the importance of conducting ePCTs for knowledge dissemination and implementation

Moderator: Catherine Meyers

Landscape of ePCTs

Learn about the work of other ongoing pragmatic trial programs

Break/Core Representative Consultations

Core Leaders are available for one-on-one discussions to follow up on issues/topics from the Demonstration Projects

  • Biostatistics and Study Design Core: Liz Delong, PhD
  • Electronic Health Records Core: Rachel Richesson, PhD, MPH
  • Ethics and Regulatory Core: Judith Carrithers, JD, MPA
  • Health Care Systems Interactions Core: Eric Larson, MD, MPH
UH3 Demonstration Projects

Top barriers and challenges and recent generalizable lessons learned

Collaboratory's Review of Experiences with Manuscript Submissions

Devon Check, PhD

Data Sharing Plans

Adrian Hernandez, MD; Wendy Weber, ND, PhD, MPH

Lessons Learned from the Completed ePCTs

Experiences from the full lifecycle of an ePCT

Updates from the UG3 Demonstration Projects

Updates on lessons learned and challenges from Year 1, ongoing transition issues, and sustainability for the UH3 phase

Break/Core Representative Consultations
Review of Lessons Learned/Milestones from the Collaboratory and Sustainability of the Collaboratory*

Adrian Hernandez, MD

*Session topic deferred

Closing Remarks/Adjourn

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

Thursday, May 2, 2019

Videocast of the workshop on Design & Analysis of Embedded Pragmatic Clinical Trials
Welcome and Introduction

Workshop goals and expectations

Helene Langevin, MD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, ND, PhD, MPH


David Murray, PhD

Panel Discussions
Panel 1: Measurement and Data: Outcomes, Exposures, and Subgroups Based on EHR Data

Moderator: Rui Wang, PhD

  • Pragmatic Trial of Video Education in Nursing Homes (PROVEN): Vince Mor, PhD; Roee Gutman, PhD
  • STrategies to Reduce Injuries and Develop confidence in Elders (STRIDE): Nancy Latham, PhD, PT; Dave Ganz, MD, MPH; Peter Peduzzi, PhD
  • Active Bathing to Eliminate (ABATE) Infection: Susan Huang, MD, MPH; Ken Kleinman, ScD

Panel 2: To Cluster or Not to Cluster?

Moderator: Keith Goldfeld, DrPH

Pragmatic trials embedded in health care delivery systems must consider the organizational structure where individual patients are typically nested within providers, clinics, and higher level organizational units. Research design must consider trade-offs associated with elements of intervention delivery and analytical approaches that address the multi-level structure.

  • Improving Chronic Disease Management with Pieces (ICD-Pieces™): Miguel Vazquez, MD; Chul Ahn, PhD
  • Collaborative Care for Chronic Pain in Primary Care (PPACT): Lynn DeBar, PhD, MPH; William Vollmer, PhD
  • Suicide Prevention Outreach Trial (SPOT): Greg Simon, MD, MPH; Susan Shortreed, PhD

Panel 3: Choosing a Parallel Group or Stepped-Wedge Design

Moderator: Fan Li, PhD

Cluster-randomized trials are often limited in the number of clusters available for study, and therefore a variety of design alternatives are considered. One contemporary design is the stepped-wedge that leverages longitudinal follow-up of clusters and allows each cluster to be observed in both intervention and control states.

  • Lumbar Imaging with Reporting of Epidemiology (LIRE): Jerry Jarvik, MD, MPH; Patrick Heagerty, PhD
  • Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED): Ted Melnick, MD, MHS; Jim Dziura, MPH, PhD
  • A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS]): Doug Zatzick, MD; Patrick Heagerty, PhD

Panel 4: Unique Complications

Moderator: Andrea Cook, PhD

Embedded pragmatic clinical trials often encounter challenges that are associated with research embedded in a dynamic delivery system environment. Issues include questions about appropriate consent, strategies for monitoring trials for conduct quality and patient safety, and plans for handling unplanned changes in the research environment.

  • Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo): Myles Wolf, MD; Hrishikesh Chakraborty, DrPH
  • Strategies and Opportunities to Stop Colorectal Cancer in Priority Populations (STOP CRC): Bev Green, MD, MPH; William Vollmer, PhD
  • Time to Reduce Mortality in End-Stage Renal Disease (TiME): Laura Dember, MD; J. Richard Landis, PhD; Jesse Hsu, PhD
Summary and Concluding Remarks

Elizabeth Delong, PhD; Patrick Heagerty, PhD; Catherine Meyers, MD


May 2019 Steering Committee Meeting: May 2019 Steering Committee Meeting. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: Updated October 21, 2019.