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 NIH Collaboratory Trials, get updates on progress and transition plans from the UG3 NIH Collaboratory Trials, 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
Moderator: Catherine Meyers
- NIH
Richard Hodes, MD - FDA
Jacqueline Corrigan-Curay, JD, MD - Centers for Medicare and Medicaid (CMS)
Joseph Chin, MD - Implementation Science
Danny Almirall, PhD
Landscape of ePCTs
Learn about the work of other ongoing pragmatic trial programs
- Patient-Centered Outcomes Research Institute (PCORI)
Anne Trontell, MD, MPH - NIH-DoD-VA Pain Management Collaboratory
Robert Kerns, PhD - Helping to End Addiction Long-term (HEAL) Initiative
Wendy Weber, ND, PhD, MPH
Break/Core Representative Consultations
Core Leaders are available for one-on-one discussions to follow up on issues/topics from the NIH Collaboratory Trials
- 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 NIH Collaboratory Trials
Top barriers and challenges and recent generalizable lessons learned
- A Policy-Relevant U.S. Trauma Care System Pragmatic Trial for PTSD and Comorbidity (Trauma Survivors Outcomes and Support [TSOS])
Doug Zatzick, MD - Improving Chronic Disease Management with Pieces (ICD-Pieces™)
Miguel Vazquez, MD - Pragmatic Trial of Video Education in Nursing Homes (PROVEN)
Vincent Mor, PhD
Susan Mitchell, MD, MPH
Angelo Volandes, MD, MPH - Suicide Prevention Outreach Trial (SPOT)
Greg Simon, MD, MPH - Lumber Imaging with Reporting of Epidemiology (LIRE)
Jerry Jarvik, MD, MPH
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
- Collaborative Care for Chronic Pain in Primary Care (PPACT)
Lynn DeBar, PhD, MPH - Time to Reduce Mortality in End-Stage Renal Disease (TiME)
Laura Dember, MD - Active Bathing to Eliminate (ABATE) Infection
Susan Huang, MD, MPH - Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC)
Beverly Green, MD, MPH
Updates from the UG3 NIH Collaboratory Trials
Updates on lessons learned and challenges from Year 1, ongoing transition issues, and sustainability for the UH3 phase
- Personalized patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
Michael Ho, MD, PHD - Primary Palliative Care for Emergency Medicine (PRIM-ER)
Corita Grudzen, MD, MSHS - Pragmatic Trial of Parent-Focused Prevention in Pediatric Primary Care: Implementation and Adolescent Health Outcomes in Three Health Systems (GGC4H: Guiding Good Choices for Health)
Rico Catalano, PhD
Stacy Sterling, DrPH, MSW, MPH
Margaret Kuklinski, PhD - Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (EMBED)
Ted Melnick, MD, MHS
Gail D'Onofrio, MD, MS - Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE)
James Tulsky, MD
Angelo Volandes, MD, MPH - Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
Myles Wolf, MD
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
Workshop Summary on the Design and Analysis of Pragmatic Clinical Trials
Welcome and Introduction
Workshop goals and expectations
Helene Langevin, MD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, ND, PhD, MPH
Keynote
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
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