Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Joseph Ali; Margaret Antonelli; Lori Bastian; William Becker; Cynthia A Brandt; Diana J Burgess; Amy Burns; Steven P Cohen; Alison F Davis; Christopher L Dearth; Jim Dziura; Rob Edwards; Joe Erdos; Shawn Farrokhi; Julie Fritz; Mary Geda; Steven Z George; Christine Goertz; Jeffrey Goodie; Susan N Hastings; Alicia Heapy; Brian M Ilfeld; Lily Katsovich; Robert D Kerns; Tassos C Kyriakides; Allison Lee; Cynthia R Long; Stephen L Luther; Steve Martino; Michael E Matheny; Don McGeary; Amanda Midboe; Paul Pasquina; Peter Peduzzi; Michael Raffanello; Daniel Rhon; Marc Rosen; Elizabeth Russell Esposito; Dylan Scarton; Susan N Hastings; Karen Seal; Norman Silliker; Sakasha Taylor; Stephanie L Taylor; Megan Tsui; Fred S Wright; Steven Zeliadt

doi:10.1093/milmed/usab458

Optimizing the Impact of Pragmatic Clinical Trials for Veteran and Military Populations: Lessons From the Pain Management Collaboratory

Mil Med. 2022 Jul 1;187(7-8):179-185. doi: 10.1093/milmed/usab458.

Authors

Joseph Ali¹, Margaret Antonelli^{2

3}, Lori Bastian^{2

3}, William Becker^{2

3}, Cynthia A Brandt^{2

3}, Diana J Burgess^{4

5}, Amy Burns^{2

3}, Steven P Cohen⁶, Alison F Davis³, Christopher L Dearth^{7

8}, Jim Dziura³, Rob Edwards⁹, Joe Erdos^{2

3}, Shawn Farrokhi¹⁰, Julie Fritz¹¹, Mary Geda³, Steven Z George¹², Christine Goertz¹³, Jeffrey Goodie¹⁴, Susan N Hastings^{15

16}, Alicia Heapy^{2

3}, Brian M Ilfeld¹⁷, Lily Katsovich³, Robert D Kerns^{2

3}, Tassos C Kyriakides^{2

3}, Allison Lee^{2

3}, Cynthia R Long¹⁸, Stephen L Luther^{19

20}, Steve Martino^{2

3}, Michael E Matheny^{21

22}, Don McGeary²³, Amanda Midboe²⁴, Paul Pasquina^{25

26}, Peter Peduzzi³, Michael Raffanello², Daniel Rhon²⁷, Marc Rosen^{2

3}, Elizabeth Russell Esposito²⁸, Dylan Scarton²⁹, Susan N Hastings^{30

31}, Karen Seal^{32

33}, Norman Silliker³, Sakasha Taylor², Stephanie L Taylor^{34

35}, Megan Tsui²⁹, Fred S Wright², Steven Zeliadt^{28

36}

Affiliations

¹ Johns Hopkins Berman Institute of Bioethics and Bloomberg School of Public Health, Baltimore, MD 21205, USA.
² VA Connecticut Healthcare System, West Haven, CT 06516, USA.
³ Yale University School of Medicine, New Haven, CT 06520, USA.
⁴ Minneapolis VA Health Care System, Minneapolis, MN 55417, USA.
⁵ University of Minnesota Medical School, Minneapolis, MN 55455, USA.
⁶ Johns Hopkins Medical Institutions, Clarksville, MD 21029, USA0.
⁷ DoD-VA Extremity Trauma and Amputation Center of Excellence, Bethesda, MD 20814, USA.
⁸ Department of Surgery, Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center, Bethesda, MD 20814, USA.
⁹ Department of Anesthesiology, Harvard Medical School, Brigham and Women's Hospital, Chestnut Hill, MA 02467, USA.
¹⁰ Naval Medical Center San Diego, Department of Physical Therapy, San Diego, CA 92134, USA.
¹¹ University of Utah, College of Health, Salt Lake City, UT 84108, USA.
¹² Duke Clinical Research Institute and Department of Orthopaedic Surgery, Duke University, Durham, NC 27715, USA.
¹³ Spine IQ, Oskaloosa, IA 52577, USA.
¹⁴ School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
¹⁵ Duke University School of Medicine, Durham, NC 27710, USA.
¹⁶ Durham VA Health Care System, Durham, NC 27705, USA.
¹⁷ Department of Anesthesiology, University of California San Diego School of Medicine, LaJolla, CA 92093, USA.
¹⁸ Palmer Center for Chiropractic Research, Davenport, IA 52803, USA.
¹⁹ James A. Haley Veterans Hospital, Tampa, FL 33612, USA.
²⁰ University of South Florida College of Public Health, Tampa, FL 33612, USA.
²¹ Tennessee Valley Healthcare System, Nashville, TN 37212, USA.
²² Department of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN 37212, USA.
²³ Department of Psychiatry & Behavioral Sciences, University of Texas Health Science Center, San Antonio, TX 78229, USA.
²⁴ VA Palo Alto Health Care System, Palo Alto, CA 94304, USA.
²⁵ Department of Physical Medicine & Rehabilitation, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
²⁶ Department of Rehabilitation, Walter Reed National Military Medical Center, Bethesda, MD 20814, USA.
²⁷ Brooke Army Medical Center, JBSA Fort Sam Houston, TX 78234, USA.
²⁸ VA Puget Sound Health Care System, Seattle, WA 98108, USA.
²⁹ Henry Jackson Foundation, Uniformed Services University of the Health Sciences, Bethesda, MD 20814, USA.
³⁰ Durham VA Medical Center, Durham, NC 27701, USA.
³¹ Department of Medicine, Duke University, Durham, NC 27708, USA.
³² University of California San Francisco, School of Medicine, San Francisco, CA 94143, USA.
³³ San Francisco VA Medical Center, San Francisco, CA 94121, USA.
³⁴ VA Greater Los Angeles Healthcare System, Los Angeles, CA 90073, USA.
³⁵ University of California Los Angeles Department of Medicine and Department of Health Policy and Management, Los Angeles, CA 90095, USA.
³⁶ University of Washington, School of Public Health, Seattle, WA 98195, USA.

Abstract

Pragmatic clinical trials (PCTs) are well-suited to address unmet healthcare needs, such as those arising from the dual public health crises of chronic pain and opioid misuse, recently exacerbated by the COVID-19 pandemic. These overlapping epidemics have complex, multifactorial etiologies, and PCTs can be used to investigate the effectiveness of integrated therapies that are currently available but underused. Yet individual pragmatic studies can be limited in their reach because of existing structural and cultural barriers to dissemination and implementation. The National Institutes of Health, Department of Defense, and Department of Veterans Affairs formed an interagency research partnership, the Pain Management Collaboratory. The partnership combines pragmatic trial design with collaborative tools and relationship building within a large network to advance the science and impact of nonpharmacological approaches and integrated models of care for the management of pain and common co-occurring conditions. The Pain Management Collaboratory team supports 11 large-scale, multisite PCTs in veteran and military health systems with a focus on team science with the shared aim that the "whole is greater than the sum of the parts." Herein, we describe this integrated approach and lessons learned, including incentivizing all parties; proactively offering frequent opportunities for problem-solving; engaging stakeholders during all stages of research; and navigating competing research priorities. We also articulate several specific strategies and their practical implications for advancing pain management in active clinical, "real-world," settings.

Publication types

Research Support, U.S. Gov't, Non-P.H.S.
Research Support, N.I.H., Extramural

MeSH terms

COVID-19
Humans
Military Personnel*
Pain Management
Pandemics
Pragmatic Clinical Trials as Topic*
Research Design
Veterans*

Abstract

Publication types

MeSH terms

Grants and funding