PRESSURE CHECK: Find Your Path to Better Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community Health Worker (CHW), Remote Blood Pressure (BP) Management Program (RBPM).
- Who it may be relevant to
- Registry conditions: Blood Pressure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Behavioral Community Health Worker (CHW)
Participants will receive the additional support of a Community Health Worker (CHW); specific activities include: 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). - Other Remote Blood Pressure (BP) Management Program (RBPM)
Participants will receive a medical model of remote BP management (RBPM). Care is 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.
Primary outcome measures
- Blood Pressure Control [Time frame: 6 months]
Secondary outcome measures (4)
- Difference in systolic BP between study groups, measured at CBO [Time frame: 6 months, 12 months, 18 months]
- Difference in BP control by study group, measured at CBO [Time frame: 6 months, 12 months, 18 months]
- Change in Well-being [Time frame: 6 months, 12 months, 18 months]
- Change in Lifestyle behaviors [Time frame: 6 months, 12 months, 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- Yale — New Haven
- Massachusetts General Brigham Hospital — Boston
- Houston Methodist — Houston
- Sentara Health — Norfolk
Identifiers
NCT: NCT06122246 · 2000036141 · HM-2022C2-28354