Steering Committee Meeting
May 14-16, 2018
Bethesda, MD
Main Purpose
Day 1: Welcome the new UG3 NIH Collaboratory Trials; provide introductions, an overview of the Collaboratory, and an understanding of the Core Working Groups; and discuss lessons learned, data sharing, and current ethics and regulatory issues.
Day 2: Celebrate the Collaboratory's progress; kick off the next 5 years; receive updates from the Core Working Groups; and hear about the top barriers/challenges and lessons learned from the UH3s.
Day 3: Intensive workshop to start discussions on embedded A vs. B pragmatic clinical trials.
Monday, May 14, 2018
Welcome, Opening Remarks, and Introductions
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Overview of a Cooperative Agreement
Wendy Weber, ND, PhD, MPH
Overview of the NIH HCS Research Collaboratory Program
David Shurtleff, PhD
Panel of Directors: Richard Hodes, MD; Wilson Compton, MD; David Murray, PhD; Bill Riley, PhD; Gary Gibbons, MD; Rob Star, MD
Collaboratory Coordinating Center Overview and Goals
Adrian Hernandez, MD, MHS
Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials
Jonathan McCall, MS
Policies and Guidance Documents
NIH Collaboratory Data Sharing Policy and Considerations
Adrian Hernandez, MD, MHS
Publications and Products Process
Eric Larson, MD, MPH
Data Quality
Rachel Richesson, PhD, MPH
New UG3 NIH Collaboratory Trials Updates
Brief overview of the projects
- Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
Michael Ho, MD, PhD; Sheana Bull, PhD, MPH - Primary Palliative Care for Emergency Medicine (PRIM-ER)
Corita Grudzen, MD, MSHS - Parents, Pediatricians, and Prevention: Pathways to Adolescent Health (P4TH)
Richard Catalano, PhD - Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED)
Ted Melnick, MD, MHS - Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (ACP PEACE)
James Tulsky, MD - Pragmatic Trial of Higher vs. Lower Serum Phosphate Targets in Patients Undergoing Hemodialysis (HiLo)
Myles Wolf, MD
NIH and Other Requirements for ClinicalTrials.gov Reporting
Deborah Zarin, MD
Results Reporting of ePCTs
Adrian Hernandez, MD, MHS
Distributed Research Network Query Capabilities
Richard Platt, MD; Lesley Curtis, PhD
Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Tuesday, May 15, 2018
Welcome and Opening Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Landscape of National ePCT Initiatives
Explanation of initiatives that are promoting ePCTs and future directions
- Patient-Centered Outcomes Research Institute (PCORI)
Anne Trontell, MD, MPH - National Institutes of Health (NIH)
Catherine Meyers, MD - Veterans Affairs (VA)
Ryan Ferguson, ScD, MPH
Health Systems Engagement Issues and Lessons Learned from the Health Care Systems Interactions Core
Eric Larson, MD, MPH
UH3 NIH Collaboratory Trials
Top barriers/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 - Collaborative Care for Chronic Pain in Primary Care (PPACT)
Lynn DeBar, PhD, MPH - Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC)
Bev Green, MD, MPH - Active Bathing to Eliminate (ABATE) Infection
Susan Huang, MD, MPH - Suicide Prevention Outreach Trial (SPOT)
Greg Simon, MD, MPH - Lumbar Imaging with Reporting of Epidemiology (LIRE)
Jerry Jarvik, MD, MPH - Time to Reduce Mortality in End-Stage Renal Disease (TiME)
Laura Dember, MD
Tuesday, May 15, 2018 (Continued)
Discussion From New UG3 NIH Collaboratory Trials
Overview of project and discussion
- Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
Michael Ho, MD, PhD; Sheana Bull, PhD, MPH - Primary Palliative Care for Emergency Medicine (PRIM-ER)
Corita Grudzen, MD, MSHS - Parents, Pediatricians, and Prevention: Pathways to Adolescent Health (P4TH)
Richard 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 - 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
CMS Quality Measures
Reena Duseja, MD
Lessons Learned From Core Groups
Discussion on generalizable knowledge created out of the Cores, how it can be used, and future work of the Cores
- Biostatistics and Study Design
Liz DeLong, PhD - Electronic Health Records
Greg Simon, MD, MPH; Rachel Richesson, PhD, MPH - Regulatory/Ethics
Adrian Hernandez, MD, MHS
Data Sharing Principles and Lessons Learned
Greg Simon, MD, MPH
Closing Remarks
David Shurtleff, PhD; Richard Hodes, MD; Lesley Curtis, PhD
Wednesday, May 16, 2018
- Videocast of the workshop on Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions
Welcome and Introduction
David Shurtleff, PhD; Richard Hodes, MD; Catherine Meyers, MD; Wendy Weber, PhD, MPH
Panel Discussions
- Steve Friedhoff, MD
- Kenneth Sands, MD, MPH
- Joseph Chin, MD
Panel 2: Examples in Action: Embedded A vs. B Trials Moderator: Beverly Green, MD, MPH
- Ryan Ferguson, ScD, MPH
- Susan Huang, MD, MPH
- Michael Kappelman, MD, MPH
- Scott Solomon, MD
- Rachael Fleurence, PhD
- Kourtney Davis, PhD, MSPH
- Jacqueline Corrigan-Curay, MD, JD
- Owen Faris, PhD
- Julie Kaneshiro, MA
- Barbara Bierer, MD
- Spencer Hey, PhD
- Judith Carrithers, JD, MPA
Summary Expert Panel Discussion Moderator: Cathy Meyers, MD
- Adrian Hernandez, MD
- Rich Platt, MD, MSc
- Beverly Green, MD, MPH
- Greg Simon, MD, MPH
- Dave Wendler, PhD
Concluding Remarks
Adrian Hernandez, MD, MHS; Rich Platt, MD, MSc
February 20-21, 2018: This workshop provided training to mid- to senior-level investigators who are interested in conducting embedded pragmatic clinical trials (ePCTs). During the workshop, the NIH Collaboratory p