PRESSURE CHECK: Find Your Path to Better Health

Yale University

Status: Enrolling

Conditions: Blood Pressure

Treatments: Behavioral: Community Health Worker (CHW); Other: Remote Blood Pressure (BP) Management Program (RBPM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06122246

2000036141

HM-2022C2-28354 (Other Grant/Funding Number)

Details and patient eligibility

About

This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.

Full description

In this comparative effectiveness trial, we aim to answer the research question of whether a remote blood pressure management program (RBPM, inclusive of home blood pressure monitoring and telehealth visits with a nurse or pharmacist delivering protocol-supported BP management, inclusive of medications and lifestyle modifications) alone or an RBPM program with community health worker (CHW) support is more effective than standard screening with education and referral to primary care in controlling blood pressure and addressing social determinants that lead to poor health outcomes.

This is a multisite study using a stepped wedge design. Health systems in 4 different cities are each partnered with 10 community based organizations (CBOs). CBOs are randomized into one of 4 sequences. Each sequence moves through the 3 study arms at different time points: Community Standard, RBPM alone, and RBPM+CHW.

At the CBOs, research health advocates screen for hypertension. Qualifying individuals who provide informed consent can enroll in the study and are assigned to the intervention that the CBO is in at that particular time. All participants receive a blood pressure cuff and a device that syncs their data with the research database. If enrolled in the RBPM arm, participants are scheduled for telehealth visits with the Pressure Check medical team to improve blood pressure control through lifestyle support and medication initiation/titration. If enrolled in the RBPM+CHW arm, participants additionally receive support from a CHW to help with medical visits and address social determinants of health. The primary outcome is blood pressure control at 6 months. Additional outcomes include implementation science to understand factors associated with adoption and outcomes, and 12 and 18 month blood pressure control.

In partnering with the community, health systems can extend their reach. CBO leaders support health messaging around hypertension and increase trust between the health system and their clients (patients). The two models, RBPM alone and RBPM+CHW, are based on the concept that disparities in hypertension control among Black, Latinx, and low-income populations exist because of inequities related to health system access and trust, individual-level socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. Addressing these barriers may improve blood pressure control.

Enrollment: 1,440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings

Exclusion criteria

• People who are pregnant or who plan to become pregnant in the next 6 months at study entry
• Those that have end stage renal disease on dialysis
• People receiving active chemotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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1,440 participants in 3 patient groups

Remote Blood Pressure (BP) Management Program

Active Comparator group

Description:

Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated.

Treatment:

Other: Remote Blood Pressure (BP) Management Program (RBPM)

Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW)

Experimental group

Description:

Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a Pressure Check nurse or pharmacist plus a social model with a CHW. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. As part of the CHW component, participants receive support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability). The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated.

Treatment:

Other: Remote Blood Pressure (BP) Management Program (RBPM)

Behavioral: Community Health Worker (CHW)

Usual Care

No Intervention group

Description:

Participants receive education about hypertension and are referred to primary care for ongoing management. If a participant does not have a PCP, they receive assistance making an appointment with a new PCP.