Clinical trial NCT05937685: Reducing Blood Pressure in Patients With High Cardiovascular Risk
Official title: BP-REACH: Blood Pressure Disparities Reduction, Equity, and Access Among Safety Net Patients With Cardiovascular Health Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Hypertension
Stroke
Keywords: stroke
myocardial infarction
hypertension
self-management
chronic disease
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
First posted: 2023-07-10
Enrollment: 546
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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?

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic blood pressure (SBP) mmHG
timeFrame: 12 months
Secondary outcomes:
measure: Life's Essential 8
timeFrame: 12 months
measure: BMI (body mass index)
timeFrame: 12 months
measure: Total cholesterol
timeFrame: 12 months
measure: HgbA1c (hemoglobin A1C)
timeFrame: 12 months
measure: Diet
timeFrame: 12 months
measure: Physical activities
timeFrame: 12 months
measure: Smoking
timeFrame: 12 months
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: LA General Medical Center
state: California
city: Sylmar
country: United States
facility: Olive View Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Alejandra Casillas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Amytis Towfighi, MD
role: PRINCIPAL_INVESTIGATOR
References: