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

NYU Langone Health

Status: Invitation-only

Conditions: Hypertension (HTN)

Treatments: Other: Practice support And Community Engagement (PACE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05208450

20-01114

Details and patient eligibility

About

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)

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

1. Refusal to participate

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

500 participants in 2 patient groups

Usual care (UC) Group

No Intervention group

Description:

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.

Intervention Group

Experimental group

Description:

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.

Treatment:

Other: Practice support And Community Engagement (PACE)