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

NCT ID: NCT05208450

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-12
• Study Completion Date: 2027-08-31

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)

Conditions

Hypertension (HTN)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Usual care (UC) Group

The study design is a randomized stepped wedge cluster trial whereby all clusters (practice sites) begin as part of the Usual Care (UC) control condition.

Clusters are then randomly assigned to cross over at different times with all clusters eventually receiving PACE. The study will involve each site starting with the UC, followed by a period of 3 months during which practice facilitators will train NCMs and CHWs, and finally followed by the PACE intervention for 12 months with a 6-month follow-up for outcome assessment. During the UC Period, patients at the sites will receive standard HTN care and standard printed HTN treatment guidelines. Immediately following this period, prior to implementation of PACE, we will conduct a practice capacity assessment at each site for 3 months. This period is then followed by the implementation of PACE.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Thus, each cluster will belong successively to the control group and the intervention group. During the control period (UC) patients at the sites will receive standard HTN care delivered by their primary care providers and standard printed HTN treatment guidelines. This period is then followed by the implementation of PACE. Clusters are randomly assigned to cross over at different times with all clusters eventually receiving PACE. During the PACE implementation period, which will last 12 months, practice facilitators will work with each site to implement the components of PACE.

Group Type: EXPERIMENTAL

Practice support And Community Engagement (PACE)

Intervention Type: 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 \[Practice support And Community Engagement (PACE)\]

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

1. Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gbenga Ogedegbe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Nadia Islam, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Antoinette Schoenthaler, EdD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36068611 (View on PubMed)

Other Identifiers

20-01114

Identifier Type: -

Identifier Source: org_study_id