Project Summary

What is the research about?

Patients can have high blood pressure (BP) levels that are uncontrolled, and this puts these individuals at higher risk for strokes and heart attacks. Monitoring BP at home between doctor visits using newer technologies that can transmit the BP values to a patient’s care team has been recommended but the full value of home monitoring and using pharmacists, nutritionists, and other team members to help control BP has not been explored, especially in minority individuals or those with social challenges. This study will compare a new model of care that uses this home BP telemonitoring combined with team-based BP control using a pharmacist to help manage BP medications and give patients advice on diet and exercise to an enhanced usual care group that only receives the monitoring device and basic instructions.

Who can this research help?

This research is especially designed to help patients, primary care providers, practices, health systems and insurance administrators learn if this new strategy will improve BP control levels and improve them more quickly, and thereby potentially reduce the risk of strokes or heart attacks.

What is the research team doing?

The research team will work with 13 primary care practice sites across North Carolina to enroll 780 adult patients (at least or more than 50 percent Black; 40 percent male) with a history of uncontrolled high BP and will assign them randomly to either the technology-enabled team care (TTC) group or the enhanced usual care (EUC) group. Both groups will be asked to check their BP at home using a provided home BP monitoring device. Patients in the TTC group will have regular phone calls from a clinically trained and experienced pharmacist that works with their doctor/provider and who has reviewed their home BP readings. This pharmacist will help them adjust their medicines and provide brief nutrition and physical activity advice, and may refer them for help with any social challenges (not enough proper food, transportation problems, etc.) that they may be experiencing. The research team involves leaders in high BP care and primary care research from leading medical schools and hospitals in North Carolina as well as patient and provider stakeholders.

Research methods at a glance:

Design: Randomized controlled trial

Population: Adults 18 years of age and older with a history of uncontrolled high BP from one of 13 primary care clinics across North Carolina

Interventions/ComparatorsTTC: Ongoing team-based, pharmacist-led telephonic management of high BP involving medications, diet and exercise, and referral for social problems and supported by telehealth-enabled weekly home BP monitoring; EUC: Home BP monitoring, basic diet and exercise instruction, and care by patient’s usual doctor/provider

OutcomesPrimary: Improved systolic BP at six months, measured as a step or more down in BP categories that are 10 mmHg wide; Secondary: Improved systolic BP at 12 months, measured as a step or more down in BP categories that are 10 mmHg wide, similar outcomes in race and sex subgroups, and the mean systolic BP reduction in each trial arm at six and 12 mo. Exploratory: Improved systolic BP, measured as a step or more down in BP categories that are 10 mmHg wide at the six- and 12-months follow-up visit within Social Vulnerability Index subgroups, hypertension self-efficacy/patient activation, therapeutic inertia, medication adherence, satisfaction with care, and DASH nutritional and physical activity behaviors, all at six and 12 months, as well as the adoption and sustainability of home BP monitoring at 18 months

Timeframe: Intervention = One year; primary and secondary outcomes at six and 12 months

Project Information

Doyle Cummings, PharmD
Jacqueline Halladay, MD, MPH
Brody School of Medicine at East Carolina University
$7,333,478 *

Key Dates

60 months *
2022

*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.

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Last updated: August 5, 2022