Provider experiences with and attitudes about an embedded pragmatic clinical trial

TL;DR

This study examined how primary care providers experienced and felt about a real-world clinical trial comparing two diuretics for cardiovascular events in older Veterans.

Contribution

The study provides insights into provider attitudes and experiences with embedded pragmatic trials in primary care settings.

Findings

Most providers found the trial question interesting and the participation time reasonable.

Very few providers felt the trial negatively affected the provider-patient relationship.

Providers were as or more comfortable with the pragmatic trial compared to traditional trials.

Abstract

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.

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.

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.

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.

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

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