training

Essentials of Embedded Pragmatic Clinical Trials Workshop: Health Care Systems Research Network Annual Conference (April 2022)

Posted on by terren.green@duke.edu

April 11, 2022: The NIH Pragmatic Trials Collaboratory hosted a Pre-Conference Workshop at the 2022 Health Care Systems Research Network (HCSRN) Annual Conference. This training workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs) and provided firsthand ePCT experiences and case studies from the NIH Pragmatic Trials Collaboratory Trials.

Workshop Summary & Additional Resources

Agenda and Slides

Welcome and Introduction

Kevin Weinfurt, PhD

Session 1: What Are Embedded PCTs (ePCTs)?
Kevin Weinfurt, PhD

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

Session 3: Measuring Outcomes
Devon Check, PhD

Session 4: ePCT Experimental Design & Analysis
Patrick Heagerty, PhD

 

Agenda and Slides

Session 5: Pilot & Feasibility Testing
Miguel Vazquez, MD

Session 6: Ethical & Regulatory Oversight Considerations
Kevin Weinfurt, PhD

Session 7: Writing a Compelling Grant Application
Michael Ho, MD, PhD

Session 8: ePCTs in Context: Panel Discussion
Moderator: Kevin Weinfurt, PhD

*This presentation contains case studies.

Session 9: Next Steps
Kevin Weinfurt, PhD

 

Case Studies

Examples from NIH Collaboratory Trials:

Convergence of Dissemination & Implementation Research Methods and Embedded Pragmatic Trials: Examples From the NIH Health Care Systems Research Collaboratory and NIA IMPACT ADRD Collaboratory (Virtual, December 2021)

Posted on by terren.green@duke.edu

December 13, 2021: The NIH Pragmatic Trials Collaboratory and the NIA IMPACT Collaboratory co-hosted a Pre-Conference Workshop for AcademyHealth’s Annual Conference on the Science of Dissemination & Implementation (D&I) in Health.  This training workshop introduced concepts in the design, conduct, and implementation of embedded pragmatic clinical trials (ePCTs), with a particular focus on the intersection between ePCTs and implementation research methods. The workshop provided an introduction to the investigative opportunities for embedded health systems research, along with strategies for integrating implementation research methods in the design and conduct of ePCTs with the goal of providing real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the NIH Health Care Systems Research Collaboratory and the NIA IMPACT ADRD Collaboratory supported and illustrated the topics presented.

Workshop Summary

Video Recording

Agenda and Slides

Welcome and Introduction

Wendy Weber, ND, PhD, MPH

Session 1: What Are Embedded Pragmatic Clinical Trials (ePCTs) and How Do They Intersect with D&I Research?

Wendy Weber, ND, PhD, MPH

Session 2: Stakeholder Engagement and Planning for D&I From the Beginning

Devon Check, PhD

Case Study Presentations
Moderator: Kevin Weinfurt, PhD

Session 3: Integrating D&I Into ePCT Study Designs & Analysis

An Overview of Hybrid Designs
Geoff Curran, PhD

Case Study Presentations
Moderator: Devon Check, PhD

Session 4: Additional Considerations When Conducting ePCTS

Ethical and Regulatory Considerations
Stephanie Morain, PhD

Pilot and Feasibility Testing
Wendy Weber, ND, PhD, MPH

A Framework for Achieving Health Equity in Pragmatic Trials
Jonathan Jackson, PhD

Case Study Presentations
Moderator: Vince Mor, PhD

Closing Remarks

David Chambers. PhD

 

Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

Posted on by terren.green@duke.edu

Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

A workshop focused on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators

Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

Posted on by dcridigital

In 2021, NIH Collaboratory Grand Rounds held a special workshop series to provide insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators. The Grand Rounds series included moderated panel discussions, case examples from the NIH Collaboratory Trials, and culminated with a podcast discussion from a panel of experts.

Agenda and Slides

Session 1: May 14, 2021: Keynote: Diverse Representation Among Clinical Trial Participants: Why it is Important and How Can We Improve

Moderator: Kanecia Zimmerman, MD
Speaker: Clyde W. Yancy, MD, MSc

Session 2: June 4, 2021: Planning for Diversity: Stakeholder Engagement and Site Selection to Maximize Diversity

Moderator: Wendy Weber, ND, PhD, MPH
Speakers: Julie Fritz, PhD, PT; David Wetter, PhD, MS; Gloria Coronado, PhD; Amanda Petrik, MS

Session 3: June 25, 2021: Meeting Participants Where They Are: Outreach, Trust, and Consent to Maximize Diversity

Moderator: Emily O'Brien, PhD
Speakers: Jonathan Jackson, PhD; Judith Schlaeger, PhD, CNM, Lac, FAAN; Stacy Sterling, DrPH, MSW, MPH

Session 4: July 16, 2021: Maximizing Diversity in PCTs: What Can We Learn From Implementation Trials

Moderator: David Chambers, DPhil
Speakers: Amanda Midboe, PhD; Anne Trontell, MD, MPS

Session 5: July 30, 2021: Diversity in the PCT Ecosystem: How Do We Develop a Pipeline of Diverse Investigators and Leaders in PCTs?

Moderator: Lesley Curtis, PhD
Speakers: Marie Bernard, MD; George Mensah, MD; Natalia Morone, MD

Session 6: August 2, 2021: Podcast: Summary Expert Panel Discussion

Moderator: Robin Boineau, MD, MA
Speakers: Kanecia Zimmerman, MD; Wendy Weber, ND, PhD, MPH; Emily O'Brien, PhD; David Chambers, DPhil; Lesley Curtis, PhD

ePCT Workshop: Health Care Systems Research Network (Virtual, May 2021)

Posted on by dcridigital

Logo for HCSRN 2021This virtual workshop introduced concepts in the design, conduct, and implementation of ePCTs, with a particular focus on methods relevant to health services researchers. The workshop provided a greater understanding of the investigative opportunities for embedded health systems research, along with strategies for conducting clinical trials that provide real-world evidence necessary to inform both practice and policy. Firsthand ePCT experiences and case studies from the Collaboratory Demonstration Projects illustrated the topics presented.

Workshop Agenda

Presenter Biosketches

 

Agenda and Slides

Day 1: May 11

Session 1: What Are Embedded PCTs (ePCTs)?

Wendy Weber, ND, PhD, MPH

View presentation

Session 2: Measuring Outcomes

Emily O'Brien, PhD

View presentation

Session 3: ePCT Design & Analysis

Patrick Heagerty, PhD

View presentation

Day 2: May 12

Session 1: Pilot & Feasibility Testing

Wendy Weber, ND, PhD, MPH

View presentation

Session 2: Ethical & Regulatory Oversight Considerations

Stephanie Morain, PhD, MPH

View presentation

Session 3: Writing a Compelling Grant Application

Marcel Salive, MD, MPH

View presentation

Session 4: ICD-Pieces Case Study

Miguel Vazquez, MD

View presentation

Session 5: LIRE Case Study

Jeffrey (Jerry) G. Jarvik, MD, MPH

View presentation

Session 6: OPTIMUM Case Study

Natalia Morone, MD

View presentation

EHR Workshop Video Modules

Posted on by dcridigital

EHR Video Modules

This selection of short educational videos is drawn from our 2020 EHR Workshop Grand Rounds Series, “Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials.” The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.

Advances at the Intersection of Digital Health, EHRs, and PCTs: NIH-Hosted Workshop (May-July 2020)

Posted on by dcridigital

May-July 2020: In 2020, NIH Collaboratory Grand Rounds held a special workshop series to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series highlighted advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials. The Grand Rounds series included moderated panel discussions that focused on the use of digital technologies in pragmatic clinical trials, case examples from the NIH Collaboratory Trials, and recent initiatives from the Office of the National Coordinator for Health Information Technology to reshape standards and drive the evolution of EHRs in healthcare and research. The series culminated with a podcast discussion from a panel of experts.

Agenda and Slides

 

Session 1: May 1, 2020: Keynote: Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?

Speaker: Robert Califf, MD, MACC

Session 2: May 8, 2020: Real World Evidence: Contemporary Experience and Future Directions

Speakers: Jacqueline Corrigan-Curay, JD, MD; Joshua C. Denny, MD, MS, FACMI
Moderator: Patrick J. Heagerty, PhD

Session 3: May 29, 2020: Experiences From the Collaboratory PCTs

Speakers: Jeffrey [Jerry] G. Jarvik, MD, MPH; Lynn DeBar, PhD; Doug Zatzick, MD; Vince Mor, PhD
Moderator: Wendy Weber, ND, PhD, MPH

Session 4: June 26, 2020: Keys to Success in the Evolving EHRs Environment

Speakers: Teresa Zayas-Cabán, PhD; George [Holt] Oliver, MD, PhD; Christopher A. Longhurst, MD, MS; Rachel Richesson, PhD, MPH
Moderator: Keith Marsolo, PhD

Session 5: July 8, 2020: Podcast: Summary Expert Panel Discussion

Speakers: Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH
Moderator: Lesley H. Curtis, PhD

EHR Video Modules

Watch our selection of short educational videos drawn from this 2020 EHR Workshop Grand Rounds Series. The series highlighted advances in digital health, new approaches and evolving standards for electronic health records (EHRs), and implications for researchers conducting pragmatic trials.