Clinical trial NCT05208450: Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
Official title: Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension (HTN)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-26
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

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)

The goal for the UH3 Implementation Phase (Years 4-7, Intervention) is to evaluate a stepped-wedge cluster RCT of 20 primary care practices in Black patients with uncontrolled hypertension (HTN).


Eligibility 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 18-85 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

Exclusion Criteria:

1. Refusal to participate

Primary outcomes:
measure: Number of Nurses who adopt the PACE intervention
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Gbenga Ogedegbe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Antoinette Schoenthaler, EdD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.