training

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:

January 29, 2024: IMPACT Collaboratory Announces Health Equity Certificate Program for Pragmatic Trials Researchers

Posted on by Damon Seils

The NIA IMPACT Collaboratory announced a new online certificate program designed to empower researchers at all levels in integrating health equity considerations into embedded pragmatic clinical trials (ePCTs) for people living with dementia and their care partners.

Program Overview

This comprehensive training program, aligned with the IMPACT Collaboratory's "Best Practices for Integrating Health Equity into ePCTs for Dementia Care" document, equips researchers with the knowledge and skills to incorporate health equity considerations into design and research activities at every level of ePCTs for people living with dementia. The program covers 6 essential topic areas:

  • Getting started
  • Community Partner Engagement
  • Design and Analysis
  • Intervention Design and Implementation
  • Healthcare System and Participant Selection
  • Selecting Outcomes

Key Features

  • Free, accessible online training
  • Six courses, each including 2 to 5 brief and engaging videos
  • Self-paced learning, typically completed in 3 hours or less
  • Certificate upon successful completion of the program

Access the Training

Visit the IMPACT Collaboratory website for details and links to set up your free learning account. This account not only provides access to the health equity training program but also to other certificate programs and training materials.

The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging.

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.

November 2, 2023: NIH Pragmatic Trials Collaboratory Launches New Online Training Resources

Posted on by Elizabeth Mccamic

The NIH Pragmatic Trials Collaboratory has launched an enhanced training section of rethinkingclinicialtrials.org that includes a new series of video learning modules and reorganized and refreshed pragmatic clinical trials training resources.

The new training section features a series of 8 self-paced, guided video modules on topics that cover every phase of a pragmatic clinical trial. The learning modules feature NIH Pragmatic Trials Collaboratory experts and can be viewed as a series or individually, depending on the goals of the learner.

The revamped training section also includes a newly organized video library, a workshops page, and a resources page with a categorized index of the NIH Collaboratory’s handouts, guides, and worksheets. These new webpages allow learners to more easily find resources that match their interests through the addition of new filters, categories, and improved search functions.

“The NIH Pragmatic Trials Collaboratory has a wealth of resources that are now easier and more engaging to use,” said Kevin Weinfurt, PhD, a co-principal investigator for the NIH Pragmatic Trials Collaboratory Coordinating Center. “I look forward to seeing how learners engage with our enhanced content and hope that the resources inspire future pragmatic clinical trials.”

The NIH Pragmatic Trials Collaboratory Coordinating Center led the training resource enhancements in partnership with Symphony Learning Partners. Additional learning tools will be available in the coming months.

“I’m excited for learners to experience our enhanced training offerings, which include a wealth of knowledge we’ve generated as a program,” said Tammy Reece, MS, PMP, CCRA, program director of the NIH Pragmatic Trials Collaboratory Coordinating Center. “This is a unique online resource in the field of pragmatic research that will continue to expand.”

July 12, 2023: Workshop Materials Now Available From ‘Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings’

Posted on by Damon Seils

Photo of group discussion at the AcademyHealth WorkshopComplete materials are now available from the NIH Pragmatic Trials Collaboratory’s recent workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings.“

The 2-day workshop, held in June at the 2023 AcademyHealth Annual Research Meeting in Seattle, 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. Presenters shared firsthand experiences and case studies from the NIH Collaboratory Trials.

The learning objectives of the workshop included:

  • To clarify the definition of embedded pragmatic clinical trials and explain their utility.
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing these trials within diverse healthcare systems.
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic trials in real-world settings, driving tomorrow’s research outcomes.

Access the complete workshop materials, including slides, speaker biographies, and the full participant guide.

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

Posted on by Lauren Stewart

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
Speaker Biographies
Program Overview
Participant Guide

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

Day 2: June 24

Welcome and Opening Remarks

Kevin Weinfurt, PhD

Session 8: Pilot and Feasibility Testing
Wendy Weber, ND, PhD, MPH

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: Vince Mor, PhD
Panel: Margaret Kuklinski, PhD; Ardith Doorenbos, Phd

Closing Remarks

Kevin Weinfurt, PhD

 

Case Studies

Examples from NIH Collaboratory Trials:

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

Posted on by Lauren Stewart

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.

Workshop Agenda

Workshop Description

Workshop Summary

Videocast Recording: Day 1

Videocast Recording: Day 2

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

 

May 8, 2023: Pragmatic Trials Workshop Offered at AcademyHealth Conference

Posted on by Damon Seils

Logo for AcademyHealthThe NIH Pragmatic Trials Collaboratory is partnering with AcademyHealth to offer a 1.5-day preconference workshop at the 2023 Annual Research Meeting in Seattle, Washington.

The workshop, “Driving Tomorrow’s Outcomes Through Clinical Research in Real-World Settings,” will cover the essentials of embedded healthcare systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Attendees will participate in facilitated, hands-on learning activities and interact with principal investigators of pragmatic clinical trials embedded in healthcare systems, including NIH Collaboratory Trials.

Firsthand experiences and case studies from the NIH Collaboratory will support and illustrate the topics presented and demonstrate how pragmatic trials embedded in real-world settings are driving tomorrow’s outcomes. Speakers will include program officers and senior staff from NIH Institutes, Centers, and Offices and senior investigators from the NIH Collaboratory Trials and the Coordinating Center leadership.

The learning objectives of the workshop include:

  • To clarify the definition of embedded pragmatic clinical trials and explain their utility.
  • To introduce attendees to the unique characteristics and challenges of designing, conducting, and implementing these trials within diverse healthcare systems.
  • To increase the capacity of health services researchers to address important clinical questions with pragmatic trials in real-world settings, driving tomorrow’s research outcomes.

Workshop details and registration
Friday, June 23, 2023, 8:15 a.m.-4:25 p.m.
Saturday, June 24, 2023, 8:00 a.m.-12:00 p.m.
Seattle Convention Center
Seattle, Washington

Intervention Complexity Calculator

Posted on by Lauren Stewart

Intervention Complexity Calculator

The Intervention Complexity Calculator was developed as a standard tool to capture intervention complexity with the intent to enhance communication challenges of intervention delivery.

This version of the tool is most likely to be useful to the trial team and its health care system partners during trial planning and conduct. The tool was developed with an awareness of intervention complexity literature, but it was not our intent to create a comprehensive classification approach. We expect that this tool may further evolve with as more pragmatic trials are conducted and feedback is received on the tool performance.

For further details, see the Living Textbook Chapter on Intervention Complexity.