Highlight
– Remote blood pressure (BP) monitoring enrollment remains a challenge despite its clinical benefits.
– A pragmatic 3-arm RCT assessed whether behavioral economic opt-out framing improves enrollment and retention versus opt-in framing.
– No significant difference was observed in enrollment rates, BP data submissions, or patient engagement between opt-out and opt-in groups.
– Both intervention groups achieved higher rates of blood pressure control than usual care, underscoring benefits of remote monitoring.
Study Background and Disease Burden
Hypertension affects nearly half of adults worldwide and remains a leading risk factor for cardiovascular morbidity and mortality. Effective blood pressure (BP) management reduces stroke, myocardial infarction, and mortality risks. Remote BP monitoring facilitates timely home-based measurement, enabling real-time clinical adjustments and enhanced patient engagement. However, widespread implementation faces barriers, notably low patient enrollment and sustained engagement, limiting its impact on blood pressure control and clinical outcomes. Behavioral economic strategies, such as opt-out framing where patients are automatically enrolled unless they decline, have improved uptake in various health interventions. Yet, their efficacy in remote BP monitoring programs required rigorous evaluation.
Study Design
This pragmatic, three-arm randomized clinical trial conducted at an academic family medicine practice in Philadelphia enrolled 424 patients aged 18 to 75 years with diagnosed hypertension. Eligibility required patients to have used text messaging, have at least two elevated BP readings over the prior 24 months, and be prescribed antihypertensive medication. Participants were randomized 2:2:1 into three groups: (1) opt-in remote BP monitoring recruitment, (2) opt-out recruitment, and (3) usual care control.
In the opt-in group, patients received outreach to consent and enroll, after which consenting patients were provided home BP monitors. The opt-out group received home BP monitors automatically prior to consent, accompanied by similar recruitment outreach. Both intervention arms engaged participants over six months via weekly text message reminders to submit BP readings and received support from social partners or clinicians as needed. The control group received usual care without remote monitoring.
The primary outcome was the proportion of patients in the intervention arms consenting to remote BP monitoring enrollment. Secondary outcomes included the number of BP measurements submitted, proportion of patients actively engaged, BP values, and the proportion achieving controlled BP.
Key Findings
Among 424 randomized patients (171 opt-in, 168 opt-out, 85 controls), the mean age was 52.1 years, and 62.3% were female. Enrollment rates in remote BP monitoring were comparable: 33.9% (58 patients) in the opt-in arm and 37.5% (63 patients) in the opt-out arm, with no statistically significant difference (difference: 3.6 percentage points; 90% CI, -5.0 to 12.1 pp; P = .49).
The mean number of BP readings submitted during the 6-month period did not differ significantly between opt-in and opt-out groups (unadjusted difference: -0.03 measurements; 95% CI, -0.09 to 0.03; P = .30). Similarly, the proportions of actively engaged patients were similar (absolute difference: -0.7 percentage points; 90% CI, -15.6 to 14.3; P = .94).
Importantly, BP control rates measured during clinic visits favored the intervention groups compared to usual care. Controlled BP was achieved in 32.2% of opt-in patients and 38.1% of opt-out patients, against 21.2% in controls. Compared to controls, the opt-in arm showed an 11.7 percentage point increase (95% CI, -0.2 to 23.5 pp; P = .05), while the opt-out arm showed an 18.0 percentage point increase (95% CI, 6.1 to 30.0 pp; P = .003), indicating statistically significant improvement only for the opt-out group.
No safety concerns or adverse events were reported related to remote BP monitoring or behavioral framing.
Expert Commentary
This trial provides valuable insights into the application of behavioral economic principles in promoting remote health monitoring for hypertension. Despite the theoretical appeal of opt-out framing—often associated with increased participation in organ donation and retirement savings programs—it did not significantly improve enrollment or engagement in this context. Multiple factors likely attenuated its impact: patient concerns about technology use, perceived burden of frequent measurements, or clinical inertia could have limited efficacy.
Moreover, both intervention groups demonstrated enhanced BP control versus usual care, emphasizing the clinical value of remote monitoring itself regardless of framing strategy. This aligns with growing evidence supporting telemonitoring for hypertension management. However, low overall uptake (approximately one-third) underscores that framing alone is insufficient—more comprehensive, multifaceted strategies targeting patient education, clinician involvement, and systemic barriers may be required.
Study limitations include the single-center design potentially limiting generalizability, reliance on text messaging which may exclude less tech-savvy populations, and relatively short follow-up. Further research might explore tailored behavioral interventions, integration with digital health platforms, and cost-effectiveness analyses.
Conclusion
In this well-conducted randomized clinical trial, applying opt-out behavioral economic framing did not significantly enhance enrollment or retention in a remote blood pressure monitoring program compared with opt-in framing. However, both approaches were associated with improved BP control relative to usual care, highlighting the potential benefits of remote monitoring in hypertension management. These findings call for innovative, patient-centered approaches beyond framing to increase participation and engagement, critical for maximizing the promise of remote health technologies.
References
1. Mehta SJ, Teel J, Okorie E, et al. Behavioral Economic Framing for Enrollment and Retention of Patients in Remote Blood Pressure Monitoring: A Randomized Clinical Trial. JAMA Netw Open. 2025;8(9):e2529825. doi:10.1001/jamanetworkopen.2025.29825.
2. Agarwal R, Bills JE, Hecht TJ, Budoff MJ. Role of Home Blood Pressure Monitoring in Hypertension Management. J Am Coll Cardiol. 2020;75(22):2764-2776.
3. Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl J Med. 2018;378(3):214-216.
4. Omboni S, Caserini M, Coronetti C. Telemedicine and M-health in Hypertension Management: Technologies, Applications and Clinical Evidence. High Blood Press Cardiovasc Prev. 2016;23(3):187-196.