This proposal seeks to address inequities in hypertension control and management through community partnerships. The project team will screen for high blood pressure in community-based organizations and test whether remote blood pressure management (RBPM) with a medical team and trained community health workers (CHWs) are effective in improving blood pressure control and overall well-being. This study will be conducted in neighborhoods that are predominantly comprised of Black, Hispanic and/or low-income residents and that have high rates of hypertension and cardiovascular disease. Four institutions have committed to implementing this study in their respective urban areas, including Yale New Haven Health System in New Haven, Connecticut; Massachusetts General Hospital in Boston, Massachusetts; Houston Methodist in Houston, Texas and Sentara Healthcare in Norfolk, Virginia.
Uncontrolled hypertension is the leading risk factor for developing cardiovascular diseases like heart attacks and stroke. Poor blood pressure control has various causes such as unhealthy lifestyle (e.g., smoking, poor diet, lack of exercise), sociocultural factors, the physical environment and health care access and quality. These factors along with experiences of individual and institutional bias and racism, stress, economic hardship and social determinants of health (SDOH) contribute to disproportionately high rates of hypertension.
Due to the COVID-19 pandemic, poorer communities faced powerful stressors such as lack of access to care and corresponding consequences including more severe disease and disproportionate mortality. It is essential to invest in multi-level and multi-component interventions that address social and health-system inequalities as part of the full continuum of care. Hypertension control is one of the most important preventive care measures and may be more effectively delivered in the community in spaces that are more welcoming and supportive. These principles have guided project SPACE, which stands for “A Study Leveraging Community Partners and Remote Blood Pressure Monitoring to Control Hypertension and Eliminate Health Inequities.”
To reach individuals in safe, trusted locations the study team has partnered with community-based organizations (CBOs) including local barbershops, beauty salons and faith-based organizations to set up blood pressure screenings. This community-engaged study uses a stepped-wedge design, which means every CBO will proceed through three phases of the study: referral to primary care (standard community screening intervention), followed by a medical model of RBPM with support from community pharmacists and nurses, followed by the RBPM plus CHW medical and social model. CBOs will transition through these steps at different timepoints to enable comparison within and between CBOs throughout the duration of the study. The goal for each health system is to partner with 10 CBOs and enroll approximately two individuals per CBO per month for two years, for a total study sample of 1,920 participants across all four sites.
Recruitment and enrollment will occur at the CBOs. Individuals who are 18 years or older and have a resting blood pressure of ≥135/85 mmHg during the initial screening will be eligible to participate. The duration of the study is 18 months. During the first six months, participants will be exposed to the intervention (referral to primary care, RBPM or RBPM+CHW). The study team will conduct follow-up assessments at three months, six months, 12 months and 18 months, compensating participants at each timepoint with the potential to receive up to $175. Study follow-ups can be done virtually; surveys will be sent by text or email, and blood pressure can be checked at the CBO or at home. Reminders to take the survey and check blood pressure will be sent. Participant surveys and blood pressure measurements will be captured and stored in a secure digital platform called Hugo Health that engages participants as data partners. Research assistants will aid participants in connecting to the platform and provide training on how to use and sync the blood pressure monitoring device.
The primary outcome is blood pressure control of <130/80 mmHg, comparing the first screening blood pressure with the six-month blood pressure. The study team will study whether the results are sustained at 12 and 18 months. The study team will also evaluate changes in social determinants of health and lifestyle behaviors, experiences with the healthcare system, well-being and care utilization. An implementation study will provide ongoing feedback about feasibility, acceptability and impact, and will be used to inform health care investments by health systems and policy makers.
*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.