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. 2022 Mar;29(1):185-194.
doi: 10.1007/s10880-021-09790-4. Epub 2021 Jun 7.

Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations

Kathryn E Kanzler  1   2   3 , Donald D McGeary  4   5   6 , Cindy McGeary  4 , Abby E Blankenship  4 , Stacey Young-McCaughan  4 , Alan L Peterson  4   6   7 , J Christine Buhrer  8 , Briana A Cobos  4 , Anne C Dobmeyer  9 , Christopher L Hunter  10 , Aditya Bhagwat  10 , John A Blue Star  11 , Jeffrey L Goodie  12
Affiliations

Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations

Kathryn E Kanzler et al. J Clin Psychol Med Settings. 2022 Mar.

Abstract

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.

Keywords: Chronic pain; Dissemination and implementation science; Pragmatic trials; Primary care; Primary care behavioral health.

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Conflict of interest statement

Kathryn E. Kanzler, Donald D. McGeary, Cindy McGeary, Abby E. Blankenship, Stacey Young-McCaughan, Alan L. Peterson, J. Christine Buhrer, Briana A. Cobos, Anne C. Dobmeyer, Christopher L. Hunter, Aditya Bhagwat, John A. Blue Star, and Jeffrey L. Goodie declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Our study ratings on the domains presented in the PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) wheel Loudon et al., 2015; tool available at www.precis-2.org
See this image and copyright information in PMC

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