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

Study Overview
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Brief Summary
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To use practice facilitation (PF) as a practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), home BP monitoring (HBPM), and use of Community Health Workers (CHWs)] 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 20 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 20 primary care practices in Black patients with uncontrolled hypertension (HTN).

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

Conditions
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Hypertension (HTN)

Intervention / Treatment
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* Other: Practice Facilitation (PF)


Participation Criteria
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Eligibility Criteria
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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 18-85 years of age has uncontrolled HTN documented in the EHR on at least two visits in the past year (defined as an average BP ≥ 130/80 mmHg) has had an appointment with a physician in the practice for routine non-emergent primary care in the last 12 months 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 Inclusion Criteria: NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating PCFs; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-wedge cluster RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br> | Other: Practice Facilitation (PF)<br>* A practical and sustainable implementation strategy to support the implementation and evaluation of three multi-level evidence-based interventions [nurse case management (NCM), home BP monitoring (HBPM), and use of Community Health Workers (CHWs)] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE)<br>|
| No Intervention: Usual care (UC) Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Blood Pressure (BP) Control | Control is defined as: Systolic BP (SBP) < 130 mmHg and Diastolic BP (DBP) < 80 mmHg | Month 18 | 
| Organizational Implementation Costs | Organizational implementation costs will include costs for training and administering the intervention | Month 18 | 
| Incremental Cost Effectiveness Ratio (ICER) | ICER is defined as [(cost1-cost2)/(outcome1-outcome2)] and will be used to evaluate costs of implementing PACE in terms of BP control rates. | Month 18 | 
| Number of Practices that Adopted Practice Facilitation (PF) | Adoption will be defined as initiation of PF at the practice. | Month 18 | 
| PF Implementation Fidelity - Number of Practices that Displayed Adherence to PF | Adherence will be defined as continuing PF for the duration of the study. | Month 18 |