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| Name | Class |
|---|---|
| University of Utah | OTHER |
| Pastors 4 PCOR | UNKNOWN |
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Hypertension affects 1 in every 3 adults in the US and contributes to 410,000 deaths annually. Hypertension and its associated complications disproportionately affect minority populations living in urban areas. In Chicago, health status indicators show worsening disparities between black and white residents, with the highest rates of hypertension, heart disease, and stroke clustering in the predominantly black South and West Sides. Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates. However, it is unclear whether a health system centered intervention can be adapted to other settings, particularly under-resourced urban communities. Therefore, the overall goal is to support a community-centered design and adaptation of the Kaiser bundle. The investigative team will adapt the delivery model of the Kaiser bundle to be centered within churches within the South Side of Chicago, one of the most medically underserved communities in the United States. The proposed interventions are the same as in the Kaiser bundle (e.g., registry/audit and feedback, simplified treatment regimens, accurate Blood Pressure measurement) but implementation of the components of the bundle will be adapted for delivery in the community. The intervention will be carried out by local community health workers and ministry facilitators, with health clinics and hospitals in the community as support, all connected through a common data platform.
Thus, the proposed project will identify the best strategies to support adoption, implementation with fidelity, and sustainability of the Kaiser bundle in the community setting. The proposed study will follow the Exploration, Preparation, Implementation and Sustainment (EPIS) process model and implementation is rigorously evaluated using a multimethod approach to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (REAIM) evaluation framework. The specific aims are: Aim 1: Convene community stakeholders in order to adapt implementation strategies using the Dynamic Adaptation Process model. Aim 2: Design, implement, and evaluate pilot projects in order to optimize implementation strategies within the target community. Aim 3: Implement, test and evaluate an adapted implementation strategy to control hypertension through faith-based organizations in the South Side of Chicago. The study uses a hybrid Type 3 effectiveness-implementation design based within one primary community area (South Side Chicago) and in two settings (church and clinic). The overall study outcomes reach (implementation) and blood pressure (clinical effectiveness). Aim 4: Disseminate findings internally to community stakeholders and externally through creation of community implementation toolkits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practice Facilitation | Experimental | Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle |
|
| Non-Practice Facilitation | Active Comparator | implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practice Facilitation | Other | Tailored interventions provided by a trained Practice Facilitator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | The investigators will examine change in systolic blood pressure measured via automatic and manual devices as a result of participating in the intervention | 3-6 months per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of implementation | The investigators will evaluate stakeholder perceptions of the feasibility of the Kaiser BP Bundle and how it is being implemented after an iterative community-based adaptation process prior to and during the trial. This measure will use the validated Feasibility of Implementation (FIM) scale (Weiner et al. 2017) which contains 3-items rated on a scale of 1-5 (range: 3-15) with higher scores indicating greater feasibility. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Heinrich, MHA | Contact | 312-503-5477 | jennifer.heinrich@northwestern.edu | |
| Allison Carroll, PhD | Contact | 312-503-1631 | allison.carroll@northwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pastors4PCOR | Recruiting | Chicago | Illinois | 60643 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40325453 | Derived | Smith JD, Carroll AJ, Tedla YG, Sanuade OA, Merle JL, Heinrich J, Bannon J, Abramsohn EM, Ahmad FS, Lazar D, Lindau ST, McHugh MC, Khatib R, Donovan R, Pinkerton EA, Rosul LL, Walunas TL, Watson R, Ganbote T, Kandula N, Youmans QR, Davis P, Kho AN. Community intervention to reduce cardiovascular disease in Chicago (CIRCL-Chicago): protocol for a type 3 hybrid effectiveness-implementation study using a parallel cluster-randomized trial design. Implement Sci. 2025 May 5;20(1):19. doi: 10.1186/s13012-025-01431-w. |
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Available by request 1 year after completion of enrollment
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Available by request 1 year after completion of enrollment
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 29, 2024 | Jul 10, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Non-Practice Facilitation | Other | Implementation support without using Practice Facilitation |
|
| 2 years |
| Acceptability of Intervention Measure | The investigators will evaluate stakeholder perceptions of the acceptability of delivering the Kaiser BP Bundle after an iterative community-based adaptation process prior to and during the trial. This measure will use the validated Acceptability of Intervention Measure (AIM) (Weiner et al. 2017) which contains 3-items rated on a scale of 1-5 (range: 3-15) with higher scores indicating greater acceptability. | 2 years |
| Access Community Health Network | Recruiting | Chicago | Illinois | 60653 | United States |
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| Advocate Aurora Health | Recruiting | Chicago | Illinois | 60657 | United States |
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