Implementing remote patient monitoring to improve hypertension control in a primary care network: Rationale and design of the monitor-BP Cluster Randomized Trial.

BACKGROUND: Home blood pressure monitoring with clinical or technological support (Supported HBPM) is an evidence-based intervention recommended by national guidelines for improving hypertension (HTN) control. However, few healthcare systems have implemented Supported HBPM because it remains unclear how best to promote uptake among patients and clinicians, and the real-world effectiveness of Supported HBPM is unknown. The Monitor-BP Trial aims to determine the impact of implementing a flexible Supported HBPM program on practice-level HTN control and to evaluate the reach, adoption, maintenance, and cost-effectiveness of the program in a socioeconomically diverse primary care network.

METHODS: The Monitor-BP Trial takes place in 15 primary care practices affiliated with two large academic medical centers in New York City. It is a hybrid 2 effectiveness-implementation cluster randomized pre-post trial testing early implementation of a Supported HBPM program (8 practices) versus usual care (7 practices). Adult patients with diagnosed HTN and their primary care clinicians are eligible for inclusion. The intervention consists of two program options: (1) MyCare Hypertension, a low resource intensity option in which patients use their own BP devices to track home BP in the online patient portal with automated triage support for extreme readings and portal-delivered educational modules, (2) RPM Hypertension, a high resource intensity option in which patients are loaned wireless BP devices that automatically transmit home BP data to the electronic health record (EHR) with telehealth navigator onboarding and nursing support to triage extreme readings. Both options include EHR-integrated ordering and home BP data visualization for clinicians. Key features of the implementation strategy include clinician education and training via presentations, clinician prompts and reminders via e-mails and mailed postcards, detailed instructional materials for patients and clinicians via websites, and at least monthly problem-solving meetings with clinical champions to iteratively tailor implementation to individual practices. The primary effectiveness outcome is practice-level pre- to post-implementation change in the mean 12-month change in office systolic BP among patients with uncontrolled office BP at baseline. The primary implementation outcomes are reach (uptake of the Supported HBPM program by patients) and adoption (uptake of the Supported HBPM program by clinicians). Secondary outcomes include estimating the short- and long-term cost-effectiveness of the program.

CONCLUSIONS: The Monitor-BP Trial tests a scalable approach to implementing telemonitoring-enabled Supported HBPM interventions into real-world clinical settings. Our findings have the potential to inform how health systems can shift the paradigm of BP assessments from the office to the home.