Championing Hypertension Remote Monitoring for Equity and Dissemination (CHARMED): A multi-site factorial randomized...

We have evidence-based strategies such as remote patient monitoring and digital health tools to improve hypertension outcomes. Still, we lack large-scale studies focusing on disseminating these practices into routine clinical care. This is especially important to study within safety-net healthcare settings that disproportionately care for marginalized patient populations.

We will conduct a hybrid type 1 implementation trial (2 × 2 factorial design) with 25 safety-net clinics across three of California's public healthcare delivery systems, enrolling 2500 English- and Spanish-speaking patients with uncontrolled hypertension. Clinics will be randomized to receive baseline training on best practices in remote monitoring for hypertension management vs. training plus ongoing practice facilitation to support its implementation. Patients within these clinics will be randomized to receive cellular-enabled blood pressure monitors and automatic text message reminders to check their blood pressure at home vs. receipt of the same monitors as well as additional support via individually tailored text message feedback and support for hypertension management.

The primary outcome will be a change in systolic blood pressure collected during routine office visits. Secondary outcomes include changes in home blood pressure and patient-reported assessments of clinical care and medication adherence. Given the hybrid type I trial implementation, the primary implementation outcomes will be the adoption of intervention at the patient and clinic levels.

The evidence from this trial will advance implementation-focused research on hypertension management, such as the essential combination of both patient- and clinic-facing intervention strategies.

NCT, NCT06113458. Registered 23 October 2023, https://clinicaltrials.gov/study/NCT06113458.