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

University of Southern California

Status: Enrolling

Conditions: Hypertension; Stroke; Myocardial Infarction

Treatments: Behavioral: BP REACH Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05937685

1P50MD017366-01

Details and patient eligibility

About

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?

Full 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.

Enrollment: 546 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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546 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Participants receive the usual care received by patients of the medical center

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: BP REACH Intervention