SPACE-BP: Sustained Partnerships And Community Engagement for BP Control

Study Overview
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Brief Summary
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This study seeks to evaluate whether a community-partnered, multi-level health system strategy to manage elevated blood pressure (BP) in the community, either with a medical model of remote BP management (RBPM) alone or RBPM plus a social model with a community health worker (CHW), is more effective in controlling hypertension than standard community screening and referral to primary care.

Detailed Description
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In this comparative effectiveness trial, the aim of this study is to answer the research question of whether a remote blood pressure (BP) management program (RBPM, inclusive of home BP 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 BP and addressing social determinants that lead to poor health outcomes, and whether either program is more effective than the other. 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 factors, as well as socioeconomic and lifestyle factors, the physical/built environment, sociocultural factors, and discriminatory policies. This study will test the hypothesis if a medical model deployed in the community in conjunction with a CHW-driven social model that offers the full continuum of care with attendance to the social determinants of health (SDoH) will be most effective in controlling and sustaining BP control.

Official Title
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Sustained Partnerships And Community Engagement for BP Control

Conditions
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Blood Pressure

Intervention / Treatment
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* Behavioral: Community Health Worker (CHW)
* Other: Remote Blood Pressure (BP) Management Program (RBPM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Blood Pressure (BP) Management Program<br>Participants will receive a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist. | Other: Remote Blood Pressure (BP) Management Program (RBPM)<br>* Participants will receive a medical model of remote BP management (RBPM).<br>|
| Experimental: Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW)<br>Participants will receive a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist plus a social model with a CHW. | Behavioral: Community Health Worker (CHW)<br>* Participants will receive the additional support of a Community Health Worker (CHW).<br>Other: Remote Blood Pressure (BP) Management Program (RBPM)<br>* Participants will receive a medical model of remote BP management (RBPM).<br>|
| No Intervention: Usual Care<br>Participants will be monitored prior to any RBPM intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control | Participants will be assessed at 6 months for Blood Pressure (BP) control- defined as BP <130/80 mmHg. To assess BP control, participants will be assessed at Baseline, 6, 12 and 18 months with the primary endpoint of assessment as BP control at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in systolic BP between study groups, measured at CBO | Mean difference in BP measured at CBO at baseline and follow-up; take average of last 2 of 3 measurements | 6 months, 12 months, 18 months | 
| Difference in BP control by study group, measured at CBO | Proportion of participants with BP with: Ideal <120/80 mmHg Intermediate: <=135/85 mmHg Poor: >135/85mmHg | 6 months, 12 months, 18 months | 
| Change in Well-being | 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 | 6 months, 12 months, 18 months | 
| Change in Lifestyle behaviors | Differences in self-reported measures using a survey.Each measure is categorized as ideal(2 points), intermediate(1 point) or poor (0 point). | 6 months, 12 months, 18 months |