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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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)](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care (UC) Group | No 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. | |
| Intervention Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice support And Community Engagement (PACE) | Other | A practical and sustainable implementation strategy, referred to as Practice Facilitation And social deTerminants of health support utilizing CHWs (PATCH), to support the implementation and evaluation of three multi-level evidence-based interventions: [nurse case management (NCM) + remote blood pressure monitoring (RBPM) + social determinants of health (SDOH) support] delivered as an integrated community-clinic linkage model [Practice support And Community Engagement (PACE)] |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Nurses who adopt the PACE intervention | Defined at the Nurse-level who adopt both electronic health record (EHR) remote BP monitoring (RBPM) and social determinants of health (SDOH) Smartsets | Month 12 |
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UH3 IMPLEMENTATION PHASE (Years 4 - 7): INTERVENTION
Inclusion Criteria:
Patients are eligible if he/she:
Exclusion Criteria:
Patients will be ineligible for the study if they:
IMPLEMENTATION EVALUATION
Exclusion Criteria:
1. Refusal to participate
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| Name | Affiliation | Role |
|---|---|---|
| Gbenga Ogedegbe, MD, MPH | NYU Langone Health | Principal Investigator |
| Nadia Islam, PhD | NYU Langone Health | Principal Investigator |
| Antoinette Schoenthaler, EdD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36068611 | Derived | 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. |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Stepped-wedge cluster RCT
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