workshop training

Dissemination and Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions: AcademyHealth (December 2025)

Posted on by Sophia Ramirez

December 14, 2025: The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 18th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

Agenda

Speaker Biographies

Program Overview

Participant Guide

Agenda and Slides

Morning Sessions

Welcome and Opening Remarks
Emily O'Brien, PhD

Session 1: Embedded Pragmatic Clinical Trials (ePCTs) and Hybrid Effectiveness-Implementation Trials: Similarities and Differences
Hayden Bosworth, PhD

Session 2: Design and Analysis Considerations
Qilu Yu, PhD

Session 3: Measuring Effectiveness and Implementation Outcomes
Angelo Volandes, MD, MPH

Session 4: ePCTs in Context: Small Group Work Followed by Panel Discussion With NIH Collaboratory Trial PIs
Moderator: Emily O'Brien, PhD
*This session includes case study presentations.

Afternoon Sessions

Session 5: Pilot and Feasibility Testing
Lanay Mudd, PhD

Session 6: Ethical and Regulatory Considerations and Posttrial Obligations
Stephanie Morain, PhD, MPH

Session 7: Engaging and Aligning With Health System and Community Partners
Hayden Bosworth, PhD

Session 8: Posttrial Sustainment or Deimplementation of Study Interventions
Vince Mor, PhD

Session 9: ePCTs in Context: Small Group Work Followed by Panel Discussion With NIH Collaboratory Trial PIs
Moderator: Stephanie Morain, PhD, MPH
*This session includes case study presentations.

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

Closing Remarks
Beda Jean-Francois, PhD

 

Case Studies

Examples from the NIH Collaboratory Trials

ACP PEACE: Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly (Angelo Volandes, MD, MPH)

BeatPain Utah: Nonpharmacologic Pain Management in Federally Qualified Health Centers Primary Care Clinics (Julie Fritz, PhD, PT)

LungSMART Utah: Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers (David Wetter, PhD, MS)

RAMP: Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention (Diana Burgess, PhD)

PROVEN: Pragmatic Trial of Video Education in Nursing Homes (Vincent Mor, PhD)

Digging Into Dilemmas of Pragmatic Clinical Trials: NIH-Hosted Workshop (November 2025)

Posted on by Sophia Ramirez

November 4-5, 2025: This 2-day workshop focused on the perspectives of providers, healthcare systems, regulators, and payers that can inform better approaches to research embedded in healthcare delivery. A series of panels discussed considerations for research in healthcare systems across a variety of communities; platform trials as an emerging method; implications of pragmatic trials with null findings for future pragmatic research; and the role of pragmatic trials in comparative effectiveness research of artificial intelligence algorithms.

Agenda

Workshop Description

Workshop Recording

Agenda, Slides, and Recordings

Day 1: November 4

Welcome and Introduction

Wendy Weber, ND, PhD, MPH*
Helene Langevin, MD*
Presented by: Lesley Curtis, PhD

Keynote: Landscape of Healthcare in America: Gaps and Opportunities (That Researchers Need to Hear)

David Zaas, MD, MBA

Session 1: Understanding Needs and Priorities of Health Systems Across Communities

Moderator: Cherise Harrington, PhD, MPH

Panel:

  • Aimee Eden, PhD, MPH*
  • Rachel Gold, PhD, MPH
  • Caleb Holtzer, MD, MPH
  • Ann Sheehy, MD, MS*
  • Sebastian Tong, MD, MPH

Session 2: Realizing the Potential of Platform Trials

Moderator: Adrian Hernandez, MD, MHS

Panel:

  • Marianne Kearney Chase
  • Martin Landray, MB ChB, PhD
  • Gregory Levin, PhD
  • Christopher Lindsell, PhD
  • Bijoy Menon, MBBS, MD, DM, MSc

Summary and Concluding Remarks

Lesley Curtis, PhD
Cherise Harrington, PhD, MPH
Adrian Hernandez, MD, MHS
Wendy Weber, ND, PhD, MPH*

Day 2: November 5

Welcome and Introduction

Wendy Weber, ND, PhD, MPH*
Helene Langevin, MD*
Presented by: Kevin Weinfurt, PhD

Session 3: What Do We Learn From Null Pragmatic Trials?

Presenter: Kevin Weinfurt, PhD

Moderator: Josephine Briggs, MD

Panel:

  • Corita Grudzen, MD, MSHS
  • Michael Ho, MD, PhD
  • Vincent Mor, PhD
  • Miguel Vazquez, MD

Session 4: What Is the Role of ePCTs in the Age of Artificial Intelligence?

Moderator: Emily O'Brien, PhD

Panel:

  • Adrian Hernandez, MD, MHS
  • Michael Ho, MD, PhD
  • Rohan Khera, MD, MS
  • Edward Melnick, MD, MHS
  • Jeremy Sugarman, MD, MPH, MA
  • Kenneth Wiley, PhD*


Summary and Concluding Remarks

Josephine Briggs, MD
Lesley Curtis, PhD
Emily O'Brien, PhD
Wendy Weber, ND, PhD, MPH*
Kevin Weinfurt, PhD

*Participated in workshop planning but unable to attend the live event due to the federal government shutdown.

September 29, 2025: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference

Posted on by Damon Seils

Logo for the 18th Annual Conference on the Science of Dissemination and Implementation in HealthThe NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 18th Annual Conference on the Science of Dissemination and Implementation in Health in National Harbor, Maryland. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Science-Powered Strategies to Sustain and Spread Effective Interventions,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant to health services researchers.

The learning objectives of the workshop include:

  • To identify key areas of synergy between pragmatic trials and implementation research
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing pragmatic clinical trials embedded within diverse health care systems, and to describe opportunities for integrating implementation research methods into pragmatic trials
  • To increase the capacity of health services researchers to address important clinical questions with embedded pragmatic clinical trials and share lessons from implementation science for supporting intervention adoption, sustainment, scale-up, and/or deimplementation

The theme of this year’s D&I conference is “Realizing the Benefits of Dissemination & Implementation Science.” The annual conference is cohosted by the NIH and AcademyHealth.

WORKSHOP DETAILS AND REGISTRATION
Sunday, December 14, 10:00 am-6:00 pm
Gaylord National, National Harbor, Maryland
Information and registration: https://academyhealth.org/page/2025-di-adjunct-events

Dissemination and Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research: AcademyHealth (December 2024)

Posted on by Damon Seils

A photo from the 2024 AcademyHealth D&I Workshop showing panelists at a dais answering questions from workshop participants.December 8, 2024: The NIH Pragmatic Trials Collaboratory hosted a workshop at AcademyHealth's 17th Annual Conference on the Science of Dissemination and Implementation in Health. The workshop introduced concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a focus on methods relevant to health services researchers.

Agenda

Speaker Biographies

Program Overview

Participant Guide

Agenda and Slides

Morning Sessions

Welcome and Introduction
Emily O'Brien, PhD

Session 1: What Are Embedded Pragmatic Clinical Trials?
Beda Jean-Francois, PhD

Session 2: Trial Objectives and Design: An Overview of Hybrid Designs
Devon Check, PhD

Session 3: Engaging With Health System and Community Partners
Hayden Bosworth, PhD

Session 4: ePCTs in Context: Small Group Work and Panel Discussion With NIH Collaboratory Trial Investigators
Moderator: Angelo Volandes, MD, MPH
*This session includes case study presentations.

Afternoon Sessions

Session 5: Measuring Outcomes
Angelo Volandes, MD, MPH

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 and Panel Discussion With NIH Collaboratory Trials Investigators
Moderator: Stephanie Morain, PhD, MPH
*This session includes case study presentations.

Closing Remarks
Emily O'Brien, PhD

 

Case Studies

Examples from the NIH Collaboratory Trials

AIM-CP: Adapting and Implementing a Nurse Care Management Model to Care for Rural Patients With Chronic Pain (Sebastian Tong, MD, MPH)

BeatPain Utah: Nonpharmacologic Pain Management in Federally Qualified Health Centers Primary Care Clinics (Julie Fritz, PhD, PT)

Chat 4 Heart Health: Using Artificially Intelligent Text Messaging Technology to Improve American Heart Association’s Life’s Essential 8 Health Behaviors (Michael Ho, MD, PhD)

NOHARM: Nonpharmacological Options in Post-operative Hospital Based and Rehabilitation Pain Management Pragmatic Trial (Andrea Cheville, MD, MSCE)

Nudge: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Michael Ho, MD, PhD)

December 3, 2024: Sharing Results With Research Participants Raises Special Considerations in Pragmatic Trials

Posted on by Damon Seils

Cover image of the journal Clinical TrialsIn a new report from the NIH Pragmatic Trials Collaboratory, a team of bioethicists explores the ethical obligation to share aggregate results from pragmatic clinical trials with research participants. They conclude with recommendations for how to meet this obligation.

The article was published online ahead of print in Clinical Trials.

There is growing appreciation of the importance of sharing aggregate results of clinical trials with research participants. However, this practice has not been examined in the context of pragmatic clinical trials, which have special features that may complicate the ethics and logistics of sharing aggregate results.

The report’s authors summarize the ethical arguments for sharing aggregate results and describe the features of pragmatic trials that may raise logistical and other barriers to disclosure. They also discuss the important role healthcare system partners play in sharing results from pragmatic trials.

The authors offer the following recommendations:

  • Sharing aggregate results with research participants should be the default, and decisions not to share should be justified
  • Planning for sharing aggregate results should begin early in the planning of the trial
  • The healthcare care systems in which the trial is embedded should be key partners in decisions about what and how to share
  • Proactive sharing of results from a pragmatic trial that was conducted under a waiver or alteration of consent, including an explanation for why consent was not obtained in the study, can promote trust in the investigators and their healthcare system partners

Read the full report.

The article was coauthored by members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core, including Stephanie Morain, Abigail Brickler, Joseph Ali, Caleigh Propes, and Kayla Mehl of Johns Hopkins University; Pearl O’Rourke, formerly of Partners HealthCare; Kayte Spector-Bagdady of the University of Michigan; Benjamin Wilfond of the Seattle Children’s Hospital; Vasiliki Rahimzadeh of the Baylor College of Medicine; and David Wendler of the NIH Clinical Center.

October 3, 2024: JAMA Commentary Highlights Gap Between Research Results and Implementation Decisions

Posted on by Karen Staman

Headshots of Richard Platt, Hayden Bosworth, and Greg SimonIn a JAMA Viewpoint published online this week, leaders from the NIH Pragmatic Trials Collaboratory discuss the discordance between the results of pragmatic clinical trials and the implementation of those results in healthcare settings, even in settings that championed the work.

Coauthors Richard Platt, Hayden Bosworth, and Gregory Simon posit that, to provide evidence that healthcare systems leaders will actually use, changes are necessary:

  • Trials need to be faster (2 to 3 years)
  • Trials should consider outcomes that healthcare system leaders care about (such as costs and subgroup analyses)
  • The evidence required for change should be at the level that healthcare system leaders use (such as not necessarily rejecting the null hypothesis at P < .05 but also considering results of Bayesian methods and interim analyses)

Read the full article.

“We believe it is possible to make pragmatic clinical trials of policies and procedures more useful to delivery systems by accommodating their priorities, introducing flexibility in the level of evidence trials require, shortening the duration of planning and implementation, addressing system leaders’ interest in multiple outcomes and subgroup analyses, encouraging modification of protocols during the implementation phase, and by providing timely interim analyses that can guide decisions about continuing or modifying an intervention,” the authors wrote.

This work was based on an NIH Pragmatic Trials Collaboratory workshop held in 2023, Getting the Right Evidence to Decision-Makers Faster. The workshop explored the critical cycle of evidence generation to decision by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

Platt is a cochair of the NIH Collaboratory’s Distributed Research Network and the Harvard Pilgrim Health Care Institute Distinguished Professor of Population Medicine at the Harvard Pilgrim Health Care Institute and Harvard Medical School. Bosworth is a cochair of the Implementation Science Core and a professor in population health sciences at Duke University. Simon is the chair of the Health Care Systems Interactions Core and a senior investigator at the Kaiser Permanente Washington Health Research Institute.

View the full workshop materials.

Going From Zero to 100: Generating Evidence Through Pragmatic Research to Address Pressing Healthcare Issues: NIH-Hosted Workshop (July 2024)

Posted on by dcridigital

July 15-16, 2024: This 2-day workshop focused on the preparatory actions researchers can undertake in the planning and application phase (Phase Zero) to ensure pragmatic clinical trials yield actionable evidence for a variety of settings. Key aspects include formulating the right research question and engaging with patients, funders, and healthcare system leaders. The workshop also addressed challenges in initiating trials across diverse settings, such as navigating data systems, site diversification, and reducing administrative burdens.

Agenda

Workshop Description

Workshop Summary

Videocast Recording: Day 1

Videocast Recording: Day 2

Agenda and Slides

Day 1: July 15

Welcome and Introduction

Wendy Weber, ND, PhD, MPH
Helene Langevin, MD

Session 1: Phase Zero: Getting the Research Question Right

Moderator: Kevin Weinfurt, PhD

Panel:

Session 2: Engagement as the Cornerstone in Pragmatic Research

Moderator: Gregory Simon, MD

Panel:

Summary and Concluding Remarks

Lesley Curtis, PhD
Gregory Simon, MD
Wendy Weber, ND, PhD, MPH
Kevin Weinfurt, PhD

Day 2: July 16

Welcome and Introduction

Wendy Weber, ND, PhD, MPH
Helene Langevin, MD

Keynote: Connecting Lab, Clinic and Community: Communities Advancing Research Equity (CARE) for Health™

Monica Bertagnolli, MD

Session 3: How to Use Data From Disparate Data Systems

Moderator: Keith Marsolo, PhD

Panel:

Session 4: Retrofitting, Reimagining, and Redesigning Health Care Systems to Reach Populations Most Affected by Health Inequities

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

Panel:

Session 5: Overcoming Administrative Burden in Pragmatic Research

Moderator: Adrian Hernandez, MD, MHS

Panel:

Summary and Concluding Remarks

Lesley Curtis, PhD
Rosa Gonzalez-Guarda, PhD, MPH, RN
Adrian Hernandez, MD, MHS
Keith Marsolo, PhD
Wendy Weber, ND, PhD, MPH

Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials Workshop: Society for Clinical Trials (May 2024)

Posted on by Lauren Stewart

May 19, 2024: The NIH Pragmatic Trials Collaboratory hosted a preconference workshop, "Patient-Centered Research in Real-World Settings: Essentials of Embedded Pragmatic Clinical Trials,” at the 45th Annual Meeting of the Society for Clinical Trials in Boston. This training workshop introduces concepts in the design and implementation of embedded pragmatic clinical trials (ePCTs), and provides firsthand ePCT experiences and case studies from the NIH Collaboratory Trials.

Agenda
Speaker Biographies
Program Overview
Participant Guide

Agenda and Slides

Welcome and Introduction
Emily O'Brien, PhD

Session 1: What Are Embedded PCTs (ePCTs)?
Wendy Weber, ND, PhD, MPH

Session 2: Engaging and Aligning With Health System and Community Partners
Emily O'Brien, PhD

Session 3: ePCT Design and Analysis
Jonathan Moyer, PhD

Session 4: Measuring Outcomes
Angelo Volandes, MD, MPH

 

Session 5: Overview of NIH Collaboratory Trials
*This presentation contains case studies

Session 6: ePCTs in Context Part 1: Small Group Work
Emily O'Brien, PhD

Session 7: ePCTs in Context Part 2: Panel Discussion with NIH Collaboratory Trial PIs
Moderator: Emily O'Brien, PhD
Panel: Vincent Mor, PhD; Angelo Volandes, MD, MPH

Closing Remarks
Emily O'Brien, PhD; Wendy Weber, ND, PhD, MPH

 

 

Case Studies

Examples from NIH Collaboratory Trials:

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

Posted on by Lauren Stewart

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

Speaker Biographies

Program Overview

Participant Guide

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 28, 2023: Workshop Summary Now Available From ‘Getting the Right Evidence to Decision-Makers Faster’

Posted on by Karen Staman

The workshop summary is now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Getting the Right Evidence to Decision-Makers Faster.” The 2-day workshop explored the critical cycle of evidence generation by researchers to decision-making by healthcare system leaders to implement the findings of pragmatic clinical trials conducted within healthcare systems.

The workshop included 4 panels:

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

    • Panelists: Devon Check, Vincent Mor, Lynn DeBar, Kathryn Glassberg, Douglas Zatzick, Eileen Bulger, Susan Huang, Kenneth Sands, Edward Septimus; Moderator: Gregory Simon

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

    • Panelists: Kenneth Sands, Eileen Bulger, Edward Septimus, Amy Kilbourne, Rosa Gonzalez-Guarda, Patrick Heagerty; Moderator: Hayden Bosworth

  • Panel 3: Learning Faster

    • Panelists: Gloria Coronado, Natalia Morone, Corita Grudzen, Kevin Chan, Pearl O’Rourke, Cheryl Boyce, Andrea Cook; Moderator: Kevin Weinfurt

  • Panel 4: Potential Structures and Incentives for Faster Learning

    • Panelists: David Chambers, Wynne Norton, Tisha Wiley, Kenneth Sands, Edward Septimus, Gloria Coronado, Natalia Morone, Corita Grudzen; Moderator: Richard Platt

Access the complete workshop materials, including slides and videocast recordings, as well as the keynote presentation by Andrew Bindman, executive vice president and chief medical officer for Kaiser Permanente.