Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study

Self-measured blood pressure monitoring (SMBP) is essential to effective management of hypertension. This study aims to evaluate effectiveness and implementation of SMBP that leverages: cellular-enabled home BP monitors without a need for Wi-Fi or Bluetooth; simple communication modalities such as text messaging to support patient engagement; and integration into existing team-based workflows in safety-net clinics. This study will be conducted with patients in San Francisco who are treated within a network of safety-net clinics. English and Spanish-speaking patients with diagnosed hypertension will be eligible for the trial if they have recent BP readings ≥140/90 mmHg and do not have co-morbid conditions that make home BP monitoring more complex to manage. This study will implement a three-arm randomized controlled trial to compare varying levels of implementation support: 1) cellular-enabled BP monitors (with minimal implementation support), 2) cellular-enabled BP monitors with protocol-based implementation support (text reminders for patients; aggregated BP summaries sent to primary care providers), and 3) cellular-enabled BP monitors and pharmacist-led support (pharmacist coaching and independent medication adjustments). For the main analysis, we will use mixed effects linear regression to compare the change in primary outcome of systolic BP. Secondary outcomes include BP control (<140/90 mmHg), medication intensification, patient-reported outcomes, and implementation processes (i.e., engagement with the intervention). This study will design and test a digital health intervention for use in marginalized populations treated within safety net settings, evaluating both effectiveness and implementation to advance more equitable health outcomes.