Stakeholder Engagement in Pragmatic Clinical Trials: Emphasizing Relationships to Improve Pain Management Delivery and Outcomes

Author:

Bastian Lori A12,Cohen Steven P3ORCID,Katsovich Lily2,Becker William C12,Brummett Bradley R45,Burgess Diana J67ORCID,Crunkhorn Andrea E8,Denneson Lauren M9,Frank Joseph W1011,Goertz Christine12,Ilfeld Brian13,Kanzler Kathryn E14ORCID,Krishnaswamy Akshaya1516,LaChappelle Kathryn1,Martino Steve12,Mattocks Kristin45,McGeary Cindy A14,Reznik Thomas E1718,Rhon Daniel I1920ORCID,Salsbury Stacie A21,Seal Karen H1516,Semiatin Alicia M22,Shin Marlena H23,Simon Corey B12,Teyhen Deydre S24,Zamora Kara1516,Kerns, Robert D12,

Affiliation:

1. VA Connecticut Healthcare System, West Haven, CT

2. Yale School of Medicine, New Haven, CT

3. The Johns Hopkins School of Medicine, Baltimore, MD

4. VA Central Western Massachusetts Healthcare System, Leeds, MA

5. University of Massachusetts, Amherst, MA

6. VA Minneapolis Healthcare System, Minneapolis, MN

7. University of Minnesota Medical School, Minneapolis, MN

8. Defense Health Headquarters, Falls Church, VA

9. VA Portland Health Care System, Portland, OR

10. VA Eastern Colorado Health Care System, Aurora, CO

11. University of Colorado School of Medicine, Aurora, CO

12. Duke University, Durham, NC

13. University of California, San Diego, CA

14. University of Texas Health Science Center at San Antonio, San Antonio, TX

15. San Francisco VA Health Care System, San Francisco, CA

16. University of California, San Francisco, CA

17. Providence VA Medical Center, Providence, RI

18. Warren Alpert Medical School of Brown University, Providence, RI

19. Brooke Army Medical Center, Fort Sam Houston, TX

20. Uniformed Services, University of Health Sciences, Bethesda, MD

21. Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA

22. Manchester VA Medical Center, Manchester, NH

23. VA Boston Healthcare System, Boston, MA

24. Walter Reed Army Institute of Research, Silver Spring, MD

Abstract

Abstract Background The NIH-DOD-VA Pain Management Collaboratory (PMC) supports 11 pragmatic clinical trials (PCTs) on nonpharmacological approaches to management of pain and co-occurring conditions in U.S. military and veteran health organizations. The Stakeholder Engagement Work Group is supported by a separately funded Coordinating Center and was formed with the goal of developing respectful and productive partnerships that will maximize the ability to generate trustworthy, internally valid findings directly relevant to veterans and military service members with pain, front-line primary care clinicians and health care teams, and health system leaders. The Stakeholder Engagement Work Group provides a forum to promote success of the PCTs in which principal investigators and/or their designees discuss various stakeholder engagement strategies, address challenges, and share experiences. Herein, we communicate features of meaningful stakeholder engagement in the design and implementation of pain management pragmatic trials, across the PMC. Design Our collective experiences suggest that an optimal stakeholder-engaged research project involves understanding the following: i) Who are research stakeholders in PMC trials? ii) How do investigators ensure that stakeholders represent the interests of a study’s target treatment population, including individuals from underrepresented groups?, and iii) How can sustained stakeholder relationships help overcome implementation challenges over the course of a PCT? Summary Our experiences outline the role of stakeholders in pain research and may inform future pragmatic trial researchers regarding methods to engage stakeholders effectively.

Funder

Research reported in this publication was partially supported by the National Center for Complementary and Integrative Health of the National Institutes of Health

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense

Pain Management Collaboratory - Pragmatic Clinical Trials Demonstration

HSR&D Award Numbers PRIME Center

United States Department of Veterans Affairs Health Services Research and Development Service

NIH

Publisher

Oxford University Press (OUP)

Subject

Anesthesiology and Pain Medicine,Clinical Neurology,General Medicine

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