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Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks

Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05208450
Enrollment
500
Registered
2022-01-26
Start date
2025-06-12
Completion date
2027-08-31
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension (HTN)

Brief summary

To use practice facilitation (PF) + community health worker (CHW) facilitation as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions \[nurse case management (NCM), remote blood pressure monitoring (RBPM), and social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE) to address patient-, physician-, health system-, and community-level barriers to hypertension (HTN) control in Blacks across 25 primary practices within NYU Langone Health in New York City (NYC) and, in partnership with an established Community-Clinic-Academic Advisory Board and HealthFirst (NYC's largest Medicaid payer). The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 25 primary care practices in Black patients with uncontrolled hypertension (HTN)

Interventions

OTHERPractice support And Community Engagement (PACE)

A practical and sustainable implementation strategy, referred to as Practice Facilitation And social deTerminants of health support utilizing CHWs (PATCH), to support the implementation and evaluation of three multi-level evidence-based interventions: \[nurse case management (NCM) + remote blood pressure monitoring (RBPM) + social determinants of health (SDOH) support\] delivered as an integrated community-clinic linkage model \[Practice support And Community Engagement (PACE)\]

Sponsors

NYU Langone Health
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Stepped-wedge cluster RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION Inclusion Criteria: Patients are eligible if he/she: 1. identifies as Black (through EHR code or self-report) 2. is 18+ years of age 3. has a diagnosis of HTN (identified by ICD-10 codes for HTN) 4. prescribed an antihypertensive medication(s) 5. has a clinic BP \> 130/80 mmHg

Exclusion criteria

Patients will be ineligible for the study if they: 1. are deemed unable to comply with the study protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks) 2. participate in other hypertension-related clinical trials 3. have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR) 4. plan to discontinue care at the site within the next 12 months; or 5. are pregnant or planning to become pregnant in the next 12 months IMPLEMENTATION EVALUATION 1. NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating practices and interacts with at least five patients with a diagnosis of hypertension; or 2. NYULH Nurse case manager within centralized service; or 3. Staff and leadership of community- and faith-based organizations serving the Black community; or 4. NYULH Organizational leadership; or 5. NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and 6. Able and willing to provide consent

Design outcomes

Primary

MeasureTime frameDescription
Number of Nurses who adopt the PACE interventionMonth 12Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGbenga Ogedegbe, MD, MPH

NYU Langone Health

PRINCIPAL_INVESTIGATORNadia Islam, PhD

NYU Langone Health

PRINCIPAL_INVESTIGATORAntoinette Schoenthaler, EdD

NYU Langone Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026