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Enrolling by invitation NCT05208450

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

No phase Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Practice support And Community Engagement (PACE).
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Practice 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 \[Practice support And Community Engagement (PACE)\]

Primary outcome measures

  • Number of Nurses who adopt the PACE intervention [Time frame: Month 12]

Eligibility criteria

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

1\. Refusal to participate

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • NYU Langone Health — New York

Publications

  • Gyamfi J, Cooper C, Barber A, Onakomaiya D, Lee WY, Zanowiak J, Mansu M, Diaz L, Thompson L, Abrams R, Schoenthaler A, Islam N, Ogedegbe G. Needs assessment and planning for a clinic-community-based implementation program for hypertension control among blacks in New York City: a protocol paper. Implement Sci Commun. 2022 Sep 6;3(1):96. doi: 10.1186/s43058-022-00340-z. PMID 36068611

Identifiers

NCT: NCT05208450 · 20-01114

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗