Blood Pressure
Conditions
Keywords
hypertension, remote patient monitoring, community health worker, digital health
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 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
BEHAVIORALCommunity 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).
OTHERRemote 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.
Sponsors
Yale University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control | 6 months | Participants will be assessed at 6 months for Blood Pressure (BP) control- defined as BP \<130/80 mmHg. To assess BP control, blood pressure will be measured in-person at the CBO (or another location) at Baseline, 6, 12 and 18 months with the primary endpoint of assessment as BP control at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in systolic BP between study groups, measured at CBO | 6 months, 12 months, 18 months | Mean difference in BP measured at CBO at baseline and follow-up; take average of last 2 of 3 measurements |
| Difference in BP control by study group, measured at CBO | 6 months, 12 months, 18 months | Proportion of participants with BP with: Ideal \<120/80 mmHg Intermediate: \<=135/85 mmHg Poor: \>135/85mmHg |
| Change in Well-being | 6 months, 12 months, 18 months | Well-being is assessed with the 12-item 100 Million Healthier Lives. Cantrill's Ladder: stratification into Thriving, Suffering, Struggling. Will assess mean differences of 0.5 as meaningfully different |
| Change in Lifestyle behaviors | 6 months, 12 months, 18 months | Differences in self-reported measures using a survey.Each measure is categorized as "ideal"(2 points), "intermediate"(1 point) or "poor" (0 point). |
Countries
United States
Contacts
CONTACTBonnie Garmisa, MAT
CONTACTJocelyn Dorney, MPH
PRINCIPAL_INVESTIGATORErica Spatz, MD
Yale University
PRINCIPAL_INVESTIGATORRafael Perez-Escamilla, MD
Yale University
Outcome results
None listed