Abstract
IMPORTANCE: Remote blood pressure (BP) monitoring for hypertension has been limited by low participation and engagement. OBJECTIVE: To evaluate if an opt-out behavioral economic approach to remote BP monitoring improves enrollment and BP outcomes compared with an opt-in approach. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, 3-arm randomized clinical trial included patients aged 18 to 75 years with hypertension who were followed up by an academic family medicine practice in Philadelphia. Eligible patients used text messaging, had at least 2 elevated BP measurements during the prior 24 months, and were prescribed hypertension medication. Patients were randomized beginning February 25, 2021, and the last patient completed the program March 22, 2022. Data were analyzed from December 2023 to January 2024. INTERVENTIONS: Prior to consent, patients were randomized 2:2:1 to opt-in or opt-out recruitment for remote monitoring of BP or to usual-care control. The opt-in group received outreach to consent and enroll in remote monitoring, and those who consented received a home BP monitor; the opt-out group received a home BP monitor and similar recruitment and follow-up. For 6 months, participants in the opt-in and opt-out groups received weekly text messages requesting BP readings and received support from a social partner or clinician as needed. MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of all participants in the intervention arms consenting to enroll in remote BP monitoring. Secondary outcomes for the intervention groups included number of BP measurements submitted and proportion of patients actively engaged. Secondary outcomes for all participants were BP measurements and the proportion with controlled BP. RESULTS: Among 424 randomized patients (171 opt-in, 168 opt-out, and 85 control), the mean (SD) age was 52.1 (11.5) years, and 264 (62.3%) were female. A total of 58 patients (33.9%) in the opt-in and 63 (37.5%) in the opt-out arm consented to enroll in monitoring, yielding no significant difference in enrollment rate (3.6 percentage points [pp]; 90% CI, -5.0 to 12.1 pp; P = .49). There was no difference in the mean number of BP measurements submitted (unadjusted difference, -0.03 [95% CI, -0.09 to 0.03] measurements; P = .30) or proportion of actively engaged patients (absolute difference, -0.7 pp [90% CI, -15.6 to 14.3 pp]; P = .94) between intervention arms. Using BP measurements from clinic visits, 55 patients (32.2%) in the opt-in arm and 64 (38.1%) in the opt-out arm had controlled BP, compared with 18 (21.2%) in the control arm (opt-in difference vs control, 11.7 pp [95% CI, -0.2 to 23.5 pp]; P = .05; opt-out difference vs control, 18.0 pp [95% CI, 6.1-30.0 pp]; P = .003). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, the behavioral economic approach of opt-out framing vs opt-in framing did not improve enrollment and retention of patients in a remote BP monitoring program. The findings suggest additional approaches are needed to boost participation. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04714398.