Provider experiences with and attitudes about an embedded pragmatic clinical trial

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 hydroch...

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Main Authors: Sarah M. Leatherman, Britte Beaudette-Zlatanova, Gregory Robben, Peter A. Glassman, Patricia Woods, Ryan E. Ferguson, William C. Cushman, Areef Ishani
Format: Article
Language:English
Published: BMC 2025-04-01
Series:BMC Primary Care
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Online Access:https://doi.org/10.1186/s12875-025-02799-w
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author Sarah M. Leatherman
Britte Beaudette-Zlatanova
Gregory Robben
Peter A. Glassman
Patricia Woods
Ryan E. Ferguson
William C. Cushman
Areef Ishani
author_facet Sarah M. Leatherman
Britte Beaudette-Zlatanova
Gregory Robben
Peter A. Glassman
Patricia Woods
Ryan E. Ferguson
William C. Cushman
Areef Ishani
author_sort Sarah M. Leatherman
collection DOAJ
description 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 .
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spelling doaj-art-3ad6cab4ee3e458e941e16d6f532d0dd2025-08-20T03:15:12ZengBMCBMC Primary Care2731-45532025-04-012611910.1186/s12875-025-02799-wProvider experiences with and attitudes about an embedded pragmatic clinical trialSarah M. Leatherman0Britte Beaudette-Zlatanova1Gregory Robben2Peter A. Glassman3Patricia Woods4Ryan E. Ferguson5William C. Cushman6Areef Ishani7Cooperative Studies Program Coordinating Center, VA Boston Healthcare SystemCooperative Studies Program Coordinating Center, VA Boston Healthcare SystemCooperative Studies Program Coordinating Center, VA Boston Healthcare SystemPharmacy Benefits Management Services, Department of Veterans AffairsCooperative Studies Program Coordinating Center, VA Boston Healthcare SystemCooperative Studies Program Coordinating Center, VA Boston Healthcare SystemMedical Service, Memphis VA Medical CenterMinneapolis VA Healthcare SystemAbstract 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 .https://doi.org/10.1186/s12875-025-02799-wPrimary carePragmatic clinical trialsProvider experienceEmbedded trialsHypertensionDiuretics
spellingShingle Sarah M. Leatherman
Britte Beaudette-Zlatanova
Gregory Robben
Peter A. Glassman
Patricia Woods
Ryan E. Ferguson
William C. Cushman
Areef Ishani
Provider experiences with and attitudes about an embedded pragmatic clinical trial
BMC Primary Care
Primary care
Pragmatic clinical trials
Provider experience
Embedded trials
Hypertension
Diuretics
title Provider experiences with and attitudes about an embedded pragmatic clinical trial
title_full Provider experiences with and attitudes about an embedded pragmatic clinical trial
title_fullStr Provider experiences with and attitudes about an embedded pragmatic clinical trial
title_full_unstemmed Provider experiences with and attitudes about an embedded pragmatic clinical trial
title_short Provider experiences with and attitudes about an embedded pragmatic clinical trial
title_sort provider experiences with and attitudes about an embedded pragmatic clinical trial
topic Primary care
Pragmatic clinical trials
Provider experience
Embedded trials
Hypertension
Diuretics
url https://doi.org/10.1186/s12875-025-02799-w
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