Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- NYU Langone Health
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Number of Nurses who adopt the PACE intervention
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
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.
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.
Intervention: Practice support And Community Engagement (PACE) (Other)
Outcomes
Primary Outcomes
Number of Nurses who adopt the PACE intervention
Time Frame: Month 12
Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets
Secondary Outcomes
No secondary outcomes reported