Elsevier

American Heart Journal

Volume 261, July 2023, Pages 104-108
American Heart Journal

Research Letters
Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?

https://doi.org/10.1016/j.ahj.2023.03.010Get rights and content

ABSTRACT

We conducted a multi-center pragmatic trial of a low-risk intervention focused on medication adherence using an opt-out consent approach, where patients could opt out by letter and then electronically. We focus on the cohort after opt-out by mail. Here, we describe that 8% of patients opted out electronically, resulting in a 92% participation rate. Patients who self-identify as Black or Hispanic were less likely to opt out in the study, and half the study cohort was female. This demographic data is useful for planning future trials employing this approach.

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.

References (12)

  • FA Masoudi et al.

    Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure

    Am. Heart J.

    (2003)
  • M Hordijk-Trion et al.

    WJM Scholte Op Reimer. Patients enrolled in coronary intervention trials are not representative of patients in clinical practice: results from the Euro heart survey on coronary revascularization

    Eur Heart J

    (2006)
  • S Wei et al.

    Factors associated with racial and ethnic diversity among heart failure trial participants: a systematic bibliometric review

    Circ. Heart Fail.

    (2022)
  • RE Glasgow et al.

    The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial

    Trials

    (2021)
  • LC Sandy et al.

    Leave me out: patients’ characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence

    Medicine (Baltimore)

    (2021)
  • SJ Mehta et al.

    A randomized controlled trial of opt-in versus opt-out colorectal cancer screening outreach

    Am. J. Gastroenterol.

    (2018)
There are more references available in the full text version of this article.

Cited by (0)

View full text