TY - JOUR
T1 - Conducting a Pragmatic Trial in Integrated Primary Care
T2 - Key Decision Points and Considerations
AU - Kanzler, Kathryn
AU - Mcgeary, Donald D
AU - McGeary, Cindy A
AU - Blankenship, Abby E.
AU - Young-mccaughan, Stacey
AU - Peterson, Alan L
AU - Buhrer, J. Christine
AU - Cobos, Briana A.
AU - Dobmeyer, Anne C.
AU - Hunter, Christopher L.
AU - Bhagwat, Aditya
AU - Star, John A.Blue
AU - Goodie, Jeffrey L.
N1 - Funding Information:
The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702–5014 is the awarding and administering acquisition office. This work was supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory—Pragmatic Clinical Trials Demonstration Projects under Award No. W81XWH-18-2-0008. Opinions, interpretations, conclusions and recommendations are those of the authors and do not reflect an endorsement by or the official policy or position of the US Army, the Department of Defense, the Department of Health and Human Services, the Department of Veterans Affairs, or the US Government. Additional research support for this publication was provided by the National Center for Complementary and Integrative Health of the National Institutes of Health under Award Number U24AT009769 and the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under Award Number K23DK123398. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
PY - 2021
Y1 - 2021
N2 - Pragmatic trials testing the effectiveness of interventions under “real world” conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.
AB - Pragmatic trials testing the effectiveness of interventions under “real world” conditions help bridge the research-to-practice gap. Such trial designs are optimal for studying the impact of implementation efforts, such as the effectiveness of integrated behavioral health clinicians in primary care settings. Formal pragmatic trials conducted in integrated primary care settings are uncommon, making it difficult for researchers to anticipate the potential pitfalls associated with balancing scientific rigor with the demands of routine clinical practice. This paper is based on our experience conducting the first phase of a large, multisite, pragmatic clinical trial evaluating the implementation and effectiveness of behavioral health consultants treating patients with chronic pain using a manualized intervention, brief cognitive behavioral therapy for chronic pain (BCBT-CP). The paper highlights key choice points using the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) tool. We discuss the dilemmas of pragmatic research that we faced and offer recommendations for aspiring integrated primary care pragmatic trialists.
KW - Chronic pain
KW - Dissemination and implementation science
KW - Pragmatic trials
KW - Primary care
KW - Primary care behavioral health
UR - http://www.scopus.com/inward/record.url?scp=85107572044&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107572044&partnerID=8YFLogxK
U2 - 10.1007/s10880-021-09790-4
DO - 10.1007/s10880-021-09790-4
M3 - Article
AN - SCOPUS:85107572044
JO - Journal of Clinical Psychology in Medical Settings
JF - Journal of Clinical Psychology in Medical Settings
SN - 1068-9583
ER -