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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05208450
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 335
• Arms: 2
• Anticipated Duration (Months): 61

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Hypertension (HTN)	Other: Practice Facilitation (PF)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 335 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Stepped-wedge cluster RCTStepped-wedge cluster RCT
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Actions to Decrease Disparities in Risk and Engage in Shared Support for Blood Pressure Control (ADDRESS-BP) in Blacks
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Aug 31, 2027
• Anticipated Study Completion Date: Aug 31, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group	Other: Practice Facilitation (PF); 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)
No Intervention: Usual care (UC) Group

Outcome Measures

Primary Outcome Measures

1. Rates of Blood Pressure (BP) Control [Month 18]

   Control is defined as: Systolic BP (SBP) < 130 mmHg and Diastolic BP (DBP) < 80 mmHg

2. Organizational Implementation Costs [Month 18]

   Organizational implementation costs will include costs for training and administering the intervention

3. Incremental Cost Effectiveness Ratio (ICER) [Month 18]

   ICER is defined as [(cost1-cost2)/(outcome1-outcome2)] and will be used to evaluate costs of implementing PACE in terms of BP control rates.

4. Number of Practices that Adopted Practice Facilitation (PF) [Month 18]

   Adoption will be defined as initiation of PF at the practice.

5. PF Implementation Fidelity - Number of Practices that Displayed Adherence to PF [Month 18]

   Adherence will be defined as continuing PF for the duration of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 18-85 years of age

3. has uncontrolled HTN documented in the EHR on at least two visits in the past year (defined as an average BP ≥ 130/80 mmHg)

4. 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:

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

Inclusion Criteria:

1. NYULH Primary care provider (MD/DO, NP), Clinical Director, Site Administrator, Medical Assistant, or administrative staff employed at the participating PCFs; 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• NYU Langone Health
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Gbenga Ogedegbe, MD, MPH, NYU Langone Health
• Principal Investigator: Nadia Islam, PhD, NYU Langone Health
• Principal Investigator: Antoinette Schoenthaler, EdD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT05208450
• Other Study ID Numbers: 20-01114
• First Posted: Jan 26, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jun 23, 2022