Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net

Study Overview
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Brief Summary
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BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services public healthcare system. The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are: Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care? Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?

Detailed Description
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Hypertension is the leading contributor to preventable death and a major risk factor for recurrent cardiovascular events. To enhance BP control after stroke or myocardial infarction (MI), multilevel interventions are needed that incorporate health system, patient, and community level factors. BP-REACH aims to test the impact of an intervention on systolic blood pressure (SBP) for individuals with a history of stroke or MI in a randomized controlled trial in the Los Angeles Department of Health Services public healthcare system. The primary outcome will be change in systolic blood pressure (SBP) at 12 months. Hypothesis: Patients randomized to the intervention will achieve >2.4 mm Hg greater reduction in SBP at 1 year versus those randomized to usual care. The study population will include participants from the inpatient and outpatient settings in Los Angeles County Department of Health Services health centers. The participants will be randomized in a 1:1 fashion to usual care or intervention, stratified by site, language and cardiovascular event (myocardial infarction, stroke). Outcomes will be collected from all participants at Baseline, 3 month and 12 month timepoints. The primary outcome is SBP. Participants randomized to the intervention arm will receive additional a home blood pressure monitor, monthly phone calls from a health coach, and medication initiation and titration by a clinical pharmacist. The pharmacist will follow Los Angeles County Department of Health Services expected practices, which align with the ACC/AHA guidelines for blood pressure control and AHA guidelines for Secondary Stroke Prevention.

Official Title
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BP-REACH: Blood Pressure Disparities Reduction, Equity, and Access Among Safety Net Patients With Cardiovascular Health Risk

Conditions
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Myocardial Infarction, Hypertension, Stroke

Intervention / Treatment
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* Behavioral: BP REACH Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of LA General Medical Center, Rancho Los Amigos, Olive Medical Center or Harbor-UCLA Medical Center with ischemic stroke, hemorrhagic stroke, or myocardial infarction English or Spanish speaking Systolic blood pressure (SBP) ≥ 130 mm Hg Exclusion Criteria: Age < 35 years SBP < 130 mm Hg Only speaks a language other than English or Spanish Cannot provide informed consent due to dementia or aphasia

Ages Eligible for Study
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Minimum Age: 35 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Participants receive the usual care received by patients of the medical center | |
| Experimental: Intervention<br>Participants follow the intervention protocol, including receiving educational materials, a home blood pressure monitor, coaching calls from BP REACH coaches and medication management from a pharmacist. | Behavioral: BP REACH Intervention<br>* Educational materials, written and digital. Home blood pressure monitor and self management education from BP REACH coach. Monthly coaching calls from BP REACH coach. Medication management by pharmacist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure (SBP) mmHG | Collected by study staff using blood pressure monitor | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Life's Essential 8 | American Heart Association - survey measure. Score of 0-100, with 100 indicating a perfect score for cardiovascular health | 12 months | 
| BMI (body mass index) | Height (cm) and weight (kg) collected by study staff, height divided by height indicating percentage of fat on the body | 12 months | 
| Total cholesterol | Lab collection by study staff | 12 months | 
| HgbA1c (hemoglobin A1C) | Lab collection by study staff | 12 months | 
| Diet | Survey - California Health Interview Survey | 12 months | 
| Physical activities | Survey - Behavioral Risk Factor Surveillance System Survey Questionnaire | 12 months | 
| Smoking | Survey - PATH wave 1 survey | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, myocardial infarction, hypertension, self-management