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OpenTrials
Enrolling by Invitation

NCT Number: NCT05208450

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

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)

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION

Inclusion criteria

Patients are eligible if he/she:

  • identifies as Black (through EHR code or self-report)
  • is 18+ years of age
  • has a diagnosis of HTN (identified by ICD-10 codes for HTN)
  • prescribed an antihypertensive medication(s)
  • has a clinic BP > 130/80 mmHg

Exclusion criteria

Patients will be ineligible for the study if they:

  • 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)
  • participate in other hypertension-related clinical trials
  • have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR)
  • plan to discontinue care at the site within the next 12 months; or
  • are pregnant or planning to become pregnant in the next 12 months

IMPLEMENTATION EVALUATION

  • 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
  • NYULH Nurse case manager within centralized service; or
  • Staff and leadership of community- and faith-based organizations serving the Black community; or
  • NYULH Organizational leadership; or
  • NYULH Project Staff: Community Health Workers/CHW Supervisor/Practice Facilitators; and
  • Able and willing to provide consent

Exclusion criteria

  • Refusal to participate

Treatment and study plan

Practice support And Community Engagement (PACE)

Other

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)]

Primary outcomes

  1. Number of Nurses who adopt the PACE intervention

    Time frame: Month 12

    Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2022
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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