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Recruiting NCT04755153

Community Intervention to Reduce CardiovascuLar Disease in Chicago

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Practice Facilitation, Non-Practice Facilitation.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Practice Facilitation
    Tailored interventions provided by a trained Practice Facilitator
  • Other Non-Practice Facilitation
    Implementation support without using Practice Facilitation

Primary outcome measures

  • Blood pressure [Time frame: 3-6 months per patient]
Secondary outcome measures (2)
  • Feasibility of implementation [Time frame: 2 years]
  • Acceptability of Intervention Measure [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Community: patients w/in participating clinics (by clinic location in community) OR within participating churches (by location in community)
  • Age: adults (18-89 y/o)

Exclusion criteria

  • Children less that 18 years of age

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Pastors4PCOR — Chicago
  • Access Community Health Network — Chicago
  • Advocate Aurora Health — Chicago

Publications

  • 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 usi PMID 40325453

Identifiers

NCT: NCT04755153 · STU00212622

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗