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. 2025 Apr 23;26(1):121.
doi: 10.1186/s12875-025-02799-w.

Provider experiences with and attitudes about an embedded pragmatic clinical trial

Sarah M Leatherman  1   2 , Britte Beaudette-Zlatanova  3 , Gregory Robben  3 , Peter A Glassman  4   5   6 , Patricia Woods  3 , Ryan E Ferguson  3   7 , William C Cushman  8   9 , Areef Ishani  10   11
Affiliations

Provider experiences with and attitudes about an embedded pragmatic clinical trial

Sarah M Leatherman et al. BMC Prim Care. .

Abstract

Background/aims: The Diuretic Comparison Project (DCP) was a pragmatic clinical trial comparing rates of cardiovascular events between hydrochlorothiazide or chlorthalidone. VA primary care providers (PCPs) and their patients were participants in the study. Veterans ≥ 65 years taking hydrochlorothiazide were randomized to continue on hydrochlorothiazide or switch to chlorthalidone. Participating providers could decline the randomization of their patients. Providers were surveyed about their experience with DCP, and to ascertain providers' understanding of and attitudes towards embedded pragmatic trials.

Methods: A questionnaire was emailed to PCPs that provided informed consent to participate in the study. The survey asked about provider experience with the trial including interest in the study question, awareness of the study and educational materials, impact on the provider-patient relationship, burden of study participation, and their attitudes towards pragmatic trials. Respondents could also add free text comments.

Results: There were 180 completed surveys. Of those, most found the trial question of interest (91%) and found the time required to participate in the trial was reasonable (67%). Only 2 (1%) felt the study had a negative impact on the provider-patient relationship. 97% of providers were as comfortable with (59%) or more comfortable with (32%) DCP compared to traditional randomized controlled trials.

Conclusion: Responding providers' experience with DCP and their attitudes towards pragmatic trials were positive. Primary care providers indicated willingness to participate in future pragmatic trials if burden is low and it does not negatively impact patient care. Results support continued use of pragmatic embedded clinical trials in primary care.

Clinical trial registration: NCT02185417. Registered 9 July 2014. https://clinicaltrials.gov/ct2/show/NCT02185417 .

Keywords: Diuretics; Embedded trials; Hypertension; Pragmatic clinical trials; Primary care; Provider experience.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The Diuretic Comparison Project was reviewed and approved by the VA Central Institutional Review Board January 4, 2016. All participants provided informed consent to participate. DCP and the corresponding survey were conducted in accordance with the Declaration of Helsinki, International Conference on Harmonization Good Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and the Cooperative Studies Program Terms and Conditions of Award. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Provider experience with DCP survey
See this image and copyright information in PMC

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