Reducing Blood Pressure in Patients With High Cardiovascular Risk (BP-REACH)

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

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 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?

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Stroke; Hypertension
• Intervention / Treatment: Behavioral: BP REACH Intervention

Detailed Description

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 and patient 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 546
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Ayala-Rivera; Phone Number: (323) 442-0934; Email: ayalariv@usc.edu

Study Locations

• United States
  • California
    • Downey, California, United States, 90242
      • Recruiting
      • Rancho Los Amigos National Rehabilitation Center
      • Contact: Monica Ayala-Rivera; Phone Number: (323) 442-0934; Email: ayalariv@usc.edu
      • Principal Investigator: Antonio Moya, MD
    • Los Angeles, California, United States, 90033
      • Recruiting
      • LA General Medical Center
      • Contact: Monica Ayala-Rivera; Phone Number: (323) 442-0934; Email: ayalariv@usc.edu
      • Principal Investigator: Grace Kuo, MD
      • Principal Investigator: Ben Lin, MD
    • Sylmar, California, United States, 91342
      • Not yet recruiting
      • Olive View Medical Center
      • Contact: Monica Ayala-Rivera; Phone Number: (323) 442-0934; Email: ayalariv@usc.edu
      • Principal Investigator: Anthony Koppula, MD
      • Principal Investigator: Soma Wali, MD
    • Torrance, California, United States, 90502
      • Recruiting
      • Harbor UCLA Medical Center
      • Contact: Monica Ayala-Rivera; Phone Number: (323) 442-0934; Email: ayalariv@usc.edu
      • Principal Investigator: Kassi Kronfeld, MD
      • Principal Investigator: William French, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants receive the usual care received by patients of the medical center
Experimental: Intervention; 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; 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

What is the study measuring?

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
Total cholesterol	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
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
HgbA1c (hemoglobin A1C)	Lab collection by study staff	12 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: University of California, Los Angeles; University of California, Irvine
• Investigators: Principal Investigator: Alejandra Casillas, MD, University of California, Los Angeles; Principal Investigator: Amytis Towfighi, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 9, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: stroke; self-management; hypertension; myocardial infarction; chronic disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Hypertension; Myocardial Infarction; Infarction
• Other Study ID Numbers: 1P50MD017366-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No