Research LettersSecondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?
Graphical abstract
Section snippets
Methods
The study was conducted as a part of an ongoing federally funded multicenter pragmatic cardiovascular disease trial, the Nudge study, (Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications; NCT03973931). Briefly, the patients were systematically identified via the electronic health record (EHR) if they: (1) had at least 1 CV condition (hypertension, coronary artery disease, atrial fibrillation, diabetes, and hyperlipidemia) as defined by
Results
Ultimately, 6,396 patients identified via the EHR from October 2019 through May 2021 were randomized to receive messages and had not opted out via mailed card (Figure).5 Among the 6,396 patients randomized to receive text or IVR messages, 9.5% (602) received IVR messages, whereas the rest received text messages. Among the enrolled cohort receiving messages, 47% (2,975 patients) were female, 70% (4,438) were white, and mean age was 60. Most patients enrolled were from DH (85%, 5,400) and spoke
Discussion
In summary, we demonstrate the timing and differential rates of opt-outs using an electronic opt-out approach in a low-risk CV pragmatic clinical trial to improve medication adherence. Only 8% of patients opted out, resulting in a participation rate of 92% among the eligible population. Patients opted out after a median of 44 days after randomization. Overall, this resulted in a diverse trial population, with higher opt-out rates among patients identifying as white, and lower opt-out rates
Funding
PG has research funding from the National Institute of Health (5T32HL007822-24). PK has research grant support from the National Heart, Lung, and Blood Institute (NHLBI; K23HL145122) and the University of Colorado Ludeman Center for Women's Health Research. This work was supported within the NIH Pragmatic Trials Collaboratory by cooperative agreement UH3HL144163 from the NHLBI. This work also received logistical and technical support from the NIH Pragmatic Trials Collaboratory Coordinating
Conflict of interest
LAA has consulting relationships with ACI Clinical, Amgen, Boston Scientific, Cytokinetics, and Novartis; and has received grant funding from the American Heart Association, the National Institutes of Health, and the Patient-Centered Outcomes Research Institute. Remaining authors have no disclosures. PMH is supported by grants from NHLBI, VA HSR&D, and University of Colorado School of Medicine.
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