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

Primary Purpose

Hypertension (HTN)

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Practice Facilitation (PF)

About this trial

This is an interventional health services research trial for Hypertension (HTN)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual care (UC) Group

Arm Description

Outcomes

Primary Outcome Measures

Rates of Blood Pressure (BP) Control

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

Organizational Implementation Costs

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

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.

Number of Practices that Adopted Practice Facilitation (PF)

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

PF Implementation Fidelity - Number of Practices that Displayed Adherence to PF

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05208450

First Posted

January 11, 2022

Last Updated

August 9, 2023

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT05208450

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

August 31, 2027 (Anticipated)

Study Completion Date

August 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension (HTN)

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Stepped-wedge cluster RCT

Masking

None (Open Label)

Allocation

Randomized

Enrollment

335 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Title

Usual care (UC) Group

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Practice Facilitation (PF)

Intervention Description

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)

Primary Outcome Measure Information:

Title

Rates of Blood Pressure (BP) Control

Description

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

Time Frame

Month 18

Title

Organizational Implementation Costs

Description

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

Time Frame

Month 18

Title

Incremental Cost Effectiveness Ratio (ICER)

Description

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

Time Frame

Month 18

Title

Number of Practices that Adopted Practice Facilitation (PF)

Description

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

Time Frame

Month 18

Title

PF Implementation Fidelity - Number of Practices that Displayed Adherence to PF

Description

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

Time Frame

Month 18

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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 18-85 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claire Cooper, MSH

Phone

916-718-5140

Claire.cooper@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gbenga Ogedegbe, MD, MPH

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nadia Islam, PhD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Antoinette Schoenthaler, EdD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will have access to data upon reasonable request. Requests should be directed to Jennifer.zanowiak@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Citations:

PubMed Identifier

36068611

Citation

Gyamfi J, Cooper C, Barber A, Onakomaiya D, Lee WY, Zanowiak J, Mansu M, Diaz L, Thompson L, Abrams R, Schoenthaler A, Islam N, Ogedegbe G. Needs assessment and planning for a clinic-community-based implementation program for hypertension control among blacks in New York City: a protocol paper. Implement Sci Commun. 2022 Sep 6;3(1):96. doi: 10.1186/s43058-022-00340-z.

Results Reference

derived

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

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