Clinical trial NCT06122246: PRESSURE CHECK: Find Your Path to Better Health
Official title: PRESSURE CHECK: Find Your Path to Better Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Keywords: hypertension
remote patient monitoring
community health worker
digital health
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-11-08
Enrollment: 1440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Community Based Organizations (CBO) will be randomized in a cluster-randomized stepped-wedge design in which CBOs will be randomized to one of 5 sequences.
Primary purpose: TREATMENT

Brief summary: 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) 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.

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
* Those that have end stage renal disease on dialysis
* People receiving active chemotherapy

Primary outcomes:
measure: Blood Pressure Control
timeFrame: 6 months
Secondary outcomes:
measure: Difference in systolic BP between study groups, measured at CBO
timeFrame: 6 months, 12 months, 18 months
measure: Difference in BP control by study group, measured at CBO
timeFrame: 6 months, 12 months, 18 months
measure: Change in Well-being
timeFrame: 6 months, 12 months, 18 months
measure: Change in Lifestyle behaviors
timeFrame: 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Brigham Hospital
state: Massachusetts
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Norfolk
country: United States
facility: Sentara Health
state: Virginia
Study officials:
affiliation: Yale University
name: Erica Spatz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Rafael Perez-Escamilla, MD
role: PRINCIPAL_INVESTIGATOR
References: