Dissemination and Implementation in Embedded Pragmatic Trials: Raising the Bar for Real-World Research: AcademyHealth (December 2023)

December 10, 2023: The NIH Pragmatic Trials Collaboratory hosted a workshop at the 2023 AcademyHealth 16th Annual Conference on the Science of Dissemination and Implementation in Health. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Agenda and Slides

Morning Sessions

Welcome and Introduction

Emily O'Brien, PhD

Session 1: What Are Embedded Pragmatic Clinical Trials?
Emily O'Brien, PhD

Session 2: Objectives and Trial Design: An Overview of Hybrid Designs
Hayden Bosworth, PhD

Session 3: Engaging With Health System and Community Partners
Devon Check, PhD

Session 4: ePCTs in Context: Small Group Work Followed by Panel Discussion with NIH Collaboratory Trials PIs

Moderator: Emily O'Brien, PhD

*This session includes case study presentations.

Afternoon Sessions

Session 5: Measuring Outcomes
Christy Zigler, PhD, MSEd

Session 6: ePCT Design
Jonathan Moyer, PhD

Session 7: ePCT Analysis
Jonathan Moyer, PhD

Session 8: Pilot and Feasibility Testing
Beda Jean-Francois, PhD

Session 9: Ethical and Regulatory Oversight Considerations
Stephanie Morain, PhD, MPH

Session 10: Writing a Compelling Grant Application
Beda Jean-Francois, PhD

Session 11: ePCTs in Context: Small Group Work Followed by Panel Discussion with NIH Collaboratory Trials PIs

Moderator: Emily O'Brien, PhD

*This session includes case study presentations.

Concluding Remarks

Emily O'Brien, PhD

 

Case Studies

Examples from NIH Collaboratory Trials

November 1, 2023 Virtual Onboarding Meeting: iPATH, AIM-CP, I CAN DO Surgical ACP, MOMS, RAMP, and ARBOR-Telehealth

NIH Pragmatic Trials Collaboratory Onboarding Meeting

November 1, 2023
Virtual

Purpose

Welcome the new UG3 and R01 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 and R01 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trial investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Beda Jean-Francois, PhD

NIH Collaboratory Coordinating Center: Overview and Goals
Lesley Curtis, PhD

Program Policies and Guidance Documents
Rich Platt, MD, MSc
Gina Uhlenbrauck

Discussion of New NIH Collaboratory Trials

  • iPATH
    Sara Singer, PhD, MBA
  • AIM-CP
    Sebastian Tong, MD, MPH
    Kushang Patel, Phd, MPH
  • MOMs
    Stephanie Fitzpatrick, PhD
  • RAMP
    Diana Burgess, PhD
    Roni Evans, DC, MS, PhD
    Katherine Hadlandsmyth, PhD

Lessons Learned From Seasoned NIH Collaboratory Trials
Moderator: Lesley Curtis, PhD

Panel:

  • Lynn Debar, PhD
  • Angelo Volandes, MD, MPH
  • Susan Huang, MD, MPH
  • Michael Ho, MD, PhD
  • Kathleen Sluka, PT, PhD
  • Andrea Cheville, MD

Closing Remarks
Beda Jean-Francois, PhD
Lesley Curtis, PhD

July 17, 2023 Virtual Onboarding Meeting: BEST-ICU, LE8 Bot + Backup, and TAICHIKNEE

NIH Pragmatic Trials Collaboratory Onboarding Meeting

July 17, 2023
Virtual

Purpose

Welcome the new UG3 NIH Collaboratory Trials; provide introductions and an overview of the NIH Collaboratory program; hear from the new UG3 project teams; and discuss lessons learned from the seasoned NIH Collaboratory Trials investigators.

Welcome and Opening Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Overview of the NIH Pragmatic Trials Collaboratory and a Cooperative Agreement
Wendy Weber, ND, PhD, MPH

NIH Collaboratory Coordinating Center: Overview and Goals
Adrian Hernandez, PhD

Program Policies and Guidance Documents
Adrian Hernandez, MD, MHS
Damon Seils, MA

Discussion of New UG3 NIH Collaboratory Trials

  • BEST-ICU
    Michele Balas, PhD, RN, CCRN-K, FCCM, FAAN
    Eduard Vasilevskis, MD, MPH
  • TAICHIKNEE
    Chenchen Wang, MD, MSc
    Eric Roseen, DC, MSc
    Robert Saper, MD
    Helen Lavertsky, MD, MS

Lessons Learned From Seasoned NIH Collaboratory Trials
Moderator: Lesley Curtis, PhD

Panel:

  • Miguel Vazquez, MD (ICD-Pieces)
  • Sheana Bull, PhD, MPH (Nudge)
  • Angelo Volandes, MD, MPH (ACP PEACE)
  • Stacy Sterling, DrPH, MSW (GGC4H)
  • Lynn DeBar, PhD (PPACT, BackInAction)
  • Julie Fritz, PhD, PT (BeatPain Utah)

Closing Remarks
Wendy Weber, ND, PhD, MPH
Lesley Curtis, PhD

Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials: AcademyHealth (June 2023)

June 23-24, 2023: This workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials, with a focus on methods relevant to health services researchers, while providing firsthand experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Agenda and Slides

Day 1: June 23

Welcome and Opening Remarks

Kevin Weinfurt, PhD

Session 1: What are Embedded Pragmatic Clinical Trials (ePCTs)?
Wendy Weber, ND, PhD, MPH

Session 2: Engaging Stakeholders and Aligning With Health System Partners
Emily O’Brien, PhD

Session 3: Objectives and Trial Design: An Overview of Hybrid Designs
Hayden Bosworth, PhD

Session 4: Measuring Outcomes
Emily O’Brien, PhD

Session 5: ePCT Design
Patrick Heagerty, PhD

Session 6: ePCT Analysis
Patrick Heagerty, PhD

Session 7: ePCTs in Context: Small Group Work Followed by Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Kevin Weinfurt, PhD
Panel: Margaret Kuklinski, PhD; Angelo Volandes, MD; Michael Parchman, MD

Closing Remarks

Kevin Weinfurt, PhD

Getting the Right Evidence to Decision-Makers Faster: Insights From the NIH Pragmatic Trials Collaboratory: NIH-Hosted Workshop (June 2023)

June 20-21, 2023: This two-day workshop explores the critical cycle of evidence generation to decision by health system leaders to implement the findings of pragmatic clinical trials (PCTs) conducted within health care systems.

Agenda and Slides

Day 1: June 20

Welcome and Introduction

Wendy Weber, ND, PhD, MPH

Keynote: Learning Health Systems: Reflections from the C-Suite

Andrew B. Bindman, MD

Session 1: How Have Health Systems Made Decisions Based on Evidence Collected in PCTs?

Review of Collaboratory Experience
Devon Check, PhD

Moderator: Gregory Simon, MD, MPH

Panel:

Session 2: How Do We Generate the Right Evidence to Support Decision-Makers?

Moderator: Hayden Bosworth, PhD

Panel:

Summary and Concluding Remarks

Wendy Weber, ND, PhD, MPH
Richard Platt, MD, MSc
Gregory Simon, MD, MPH
Hayden Bosworth, PhD

 

Day 2: June 21

Welcome and Introduction

Wendy Weber, ND, PhD, MPH

Session 3: Learning Faster

Moderator/Speaker: Kevin Weinfurt, PhD

Panel:

Session 4: Potential Structures and Incentives for Faster Learning

Moderator: Richard Platt, MD, MSc

Panel:

  • David Chambers, DPhil
  • Wynne Norton, PhD
  • Tisha Wiley, MD

Respondents:

  • Kenneth Sands, MD
  • Edward Septimus, MD
  • Gloria Coronado, PhD
  • Natalia Morone, MD, MS
  • Corita Grudzen, MD, MSHS

Summary and Concluding Remarks

Wendy Weber, MD, PhD, MPH
Kevin Weinfurt, PhD
Richard Platt, MD, MSc

 

Changing Trials for Changing Times: Essentials of Embedded Pragmatic Clinical Trials Workshop: Health Care Systems Research Network Conference (February 2023)

February 20, 2023: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the Health Care Systems Research Network 2023 Annual Conference. This training workshop introduces concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provides firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Agenda and Slides

Morning Sessions

Welcome and Introduction

Wendy Weber, ND, PhD, MPH

Session 1: What are Embedded Pragmatic Clinical Trials (ePCTs)?
Wendy Weber, ND, PhD, MPH

Session 2: Engaging Stakeholders & Aligning with Health System Partners
Emily O’Brien, PhD

Session 3: Objectives and Trial Design: An Overview of Hybrid Designs
Patrick Heagerty, PhD

Session 4: Measuring Outcomes
Emily O’Brien, PhD

Session 5: ePCT Design and Analysis
Patrick Heagerty, PhD

Session 6ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Kevin Weinfurt, PhD

*This session includes the Case Study Presentations.

 

Afternoon Sessions

Session 7: Pilot & Feasibility Testing
Wendy Weber, ND, PhD, MPH

Session 8: Ethical & Regulatory Oversight Considerations
Stephanie Morain, PhD, MPH

Session 9: Writing a Compelling Grant Application
Beda Jean-Francois, PhD

Session 10: ePCTs in Context: Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Kevin Weinfurt, PhD

*This session includes the Case Study Presentations.

Session 11: Next Steps
Kevin Weinfurt, PhD