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Pragmatic Clinical Trials - Unique Opportunities for Disseminating, Impleme...

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National Institutes of Health Lister Hill Auditorium

8600 Rockville Pike

NIH Building 38A

Bethesda, MD 20894

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Pragmatic Clinical Trials – Unique Opportunities for Disseminating, Implementing & Sustaining Evidence-Based Practices into Clinical Care

You will be able to view the event at https://videocast.nih.gov when the event is live.

This one-day Workshop will explore challenges and strategies for the dissemination, implementation and sustainability of pragmatic clinical trial findings. Pragmatic trials are distinct from more traditional clinical trials, as they are designed to assess the impact of interventions delivered in usual or real-world conditions. Moreover, performing pragmatic trials within fully integrated health care systems facilitates large-scale, efficient trials that leverage existing infrastructure to answer important clinical questions. Pragmatic clinical trials can also bridge the critical gap between clinical evidence, practice and policy in health care systems.

The NIH Health Care Systems Research Collaboratory, initiated in 2012 by the NIH Common Fund, has launched a set of pragmatic clinical trials in partnership with several US health care systems. These trials have served as case studies for many issues related to pragmatic research, including strategies for designing trials in partnership with health care systems that plan for dissemination, implementation and sustainability of research findings. Such planning requires careful considerations for engaging all relevant stakeholders in the clinical research enterprise.

The Workshop will include a series of moderated discussions about how to plan for and include dissemination and implementation strategies in pragmatic trials with the partnering health care systems. Each presentation will utilize case examples from the Collaboratory pragmatic trials and include some of their health care system collaborators to illustrate how dissemination and implementation strategies were addressed in the various settings. The Workshop aims to inform research funders and investigators on progress in NIH-funded pragmatic clinical trials, and discuss strategies for conducting future trials that can make a difference, and readily bridge the gap between evidence, practice and policy.

Objectives:

  • Describe the unique challenges and opportunities pragmatic clinical trials (PCTs) offer in dissemination, implementation and sustainability of trial findings

  • Provide strategies to address some of these challenges from ongoing PCTs and how to take advantage of the opportunities that arise in designing PCTs

  • Identify available and needed resources to assist stakeholders in planning future pragmatic studies

We invite participants to submit questions or specific areas of concern during the registration process. We will attempt to address as many questions/areas of concern as possible during the workshop. Questions will also be welcomed by email during the workshop. Please send questions to the following address: PragClinTrialsWkshp@nih.gov



Agenda:

May 24, 2017
Lister Hill Auditorium
8:00 am – 4:30 pm


8:00 am Welcome and Introduction

Josephine P. Briggs, MD
Director
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Richard Hodes, MD
Director
National Institute on Aging
National Institutes of Health, DHHS

Catherine M. Meyers, MD
Director, Office of Clinical & Regulatory Affairs
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS



8:10 am Keynote

David Chambers, DPhil
Deputy Director for Implementation Science
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health, DHHS



8:40 am Setting the Stage for Dissemination and Implementation

Moderator: David Chambers, DPhil
Deputy Director for Implementation Science
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health, DHHS

Panel:
Susan S. Huang, MD, MPH
Professor, Infectious Diseases
Medical Director, Epidemiology and Infection Prevention
University of California, Irvine School of Medicine

Douglas F. Zatzick, MD
Professor, Psychiatry and Behavioral Sciences
University of Washington School of Medicine
Harborview Medical Center

Gloria Coronado, PhD
Senior Investigator, Mitch Greenlick Endowed Scientist for Health Disparities
Kaiser Permanente Center for Health Research
Kaiser Permanente Northwest

Moderator Summary
Q&A




10:15 am Break



10:30 am Health System Engagement: Partnership, Relationships and Transparency

Moderator: Eric B. Larson, MD, MPH
Vice President, Research and Health Care Innovation
Kaiser Foundation Health Plan of Washington
Executive Director and Senior Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington

Panel:
Miguel Vazquez, MD
Clinical Chief Nephrology Division
Professor, Internal Medicine
University of Texas Southwestern Medical Center

John J. Warner, M.D.
Chief Executive Officer, University Hospitals and Clinics
University of Texas Southwestern Medical Center

Lynn DeBar, PhD, MPH
Senior Investigator
Kaiser Permanente Center for Health Research
Kaiser Permanente Northwest

Andrew Bertagnolli, PhD
(Former) Director, Integrated Behavioral Health
Care Management Institute
Kaiser Permanente

(Current) Vice President, Behavioral Health Clinical Products
Optum United Health Group

Vincent Mor, PhD
Florence Pirce Professor of Community Health
Brown University
Senior Health Scientist, Center on Innovation
Providence Veterans Administration Medical Center

Kevin Daugherty Hook, MSN, MA, MS, CRNP
Vice President, Nursing Practice and Education
Genesis HealthCare

Moderator Summary
Q&A



12:00 pm Lunch



12:45 pm Swimming with the Sharks – Translation of Pragmatic Trial Results

Moderator: Lesley H. Curtis, PhD
Professor of Medicine
Director, Center for Population Health Sciences, Duke School of Medicine
Director, Center for Pragmatic Health Systems Research, Duke Clinical Research Institute

Presenter: Gregory E. Simon, MD, MPH
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington

Responders:
Susan Mullaney, MHA
President
Kaiser Permanente Washington

Edward J. Septimus, MD
Vice President, Research and Infectious Diseases Clinical Services Group
Hospital Corporation of America

Matt Hough, MD
Medical Director
Jackson Care Connect
Care Oregon



1:30 pm Designing for Sustainability

Moderator: Amy Kilbourne, PhD, MPH
Director, VA Quality Enhancement Research Initiative (QUERI)
US Department of Veterans Affairs
Professor of Psychiatry
University of Michigan

Laura M. Dember, MD
Professor of Medicine and Epidemiology
Perelman School of Medicine, University of Pennsylvania

Jerry Jarvik, MD, MPH
Professor
University of Washington School of Medicine

Patrick H. Luetmer, MD
Associate Dean for Clinical Systems Oversight
Mayo Clinic

Gregory E. Simon, MD, MPH
Senior Scientific Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington

Moderator Summary
Q&A



3:00 pm Break



3:15 pm Stakeholder Reactions Panel Discussion

Moderator: Catherine M. Meyers, MD

Director, Office of Clinical & Regulatory Affairs
National Center for Complementary and Integrative Health
National Institutes of Health, DHHS

Panel:
John J. Warner, M.D.
Chief Executive Officer, University Hospitals and Clinics
University of Texas Southwestern Medical Center

Susan Mullaney, MHA
President
Kaiser Permanente Washington

Kevin Daugherty Hook, MSN, MA, MS, CRNP
Vice President, Nursing Practice and Education
Genesis HealthCare

Amy Kilbourne, PhD, MPH
Director, VA Quality Enhancement Research Initiative (QUERI)
US Department of Veterans Affairs
Professor of Psychiatry
University of Michigan



4:15 pm Concluding Remarks

David Chambers, DPhil
Deputy Director for Implementation Science
Division of Cancer Control and Population Sciences
National Cancer Institute
National Institutes of Health, DHHS

Eric B. Larson, MD, MPH
Vice President, Research and Health Care Innovation
Kaiser Foundation Health Plan of Washington
Executive Director and Senior Investigator
Kaiser Permanente Washington Health Research Institute
Kaiser Permanente Washington



General Lister Hill Center Information

  • All NIH visitor information, including Parking, Driving Directions, Maps, and Security information, can be found at http://www.nih.gov/about/visitor/index.htm

  • Wireless Internet Access -- The building has wireless access.

  • Cafeteria -- On Level B-1. Located down the stairs in the center of the lobby and to the left. http://www.ors.od.nih.gov/pes/dats/food/dining/Pages/Building-38A.aspx

  • Coat Room — The coat room is directly outside the auditorium. Luggage may be stored in the coat room but NLM is not responsible for missing or stolen items. There are no NIH Guards posted in Building 38A.

  • Rest rooms and a water fountain are located next to the elevators. There are additional restrooms on each floor of the LHC building.

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Location

National Institutes of Health Lister Hill Auditorium

8600 Rockville Pike

NIH Building 38A

Bethesda, MD 20894

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