Practice Support and Community Engagement for High Blood Pressure

Overseen By Laurette Espinoza-Hernandez, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Antihypertensives

Disqualifiers: Psychiatric, Substance abuse, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

335 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

Gbenga Ogedegbe, MD, MPH

Principal Investigator

NYU Langone Health

Nadia Islam, PhD

Principal Investigator

NYU Langone Health

Antoinette Schoenthaler, EdD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

The ADDRESS-BP trial is for Black individuals with uncontrolled high blood pressure, documented on at least two visits in the past year. Participants must have had a routine non-emergent primary care appointment within the last 12 months at one of the participating NYU Langone Health practices in NYC.

Inclusion Criteria

Patients who identify as Black (through EHR code or self-report)

Patients with a clinic BP > 130/80 mmHg

I am between 18 and 85 years old.

Exclusion Criteria

Patients deemed unable to comply with the study protocol

Patients participating in other hypertension-related clinical trials

Patients with significant psychiatric comorbidity or reports of substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Usual Care (UC) Period

Patients receive standard hypertension care and printed treatment guidelines

3 months

Practice Capacity Assessment

Practice facilitators conduct a capacity assessment at each site

3 months

PACE Implementation

Implementation of PACE with practice facilitators working to implement components

12 months

Follow-up

Participants are monitored for outcome assessment after PACE implementation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Practice Facilitation

Trial Overview This trial tests an integrated community-clinic model called PACE, which includes nurse case management, remote blood pressure monitoring, and support for social determinants of health to improve hypertension control among Blacks across 25 primary care practices.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

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 II: Usual care (UC) Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+