Community Intervention to Reduce CardiovascuLar Disease in Chicago
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 2,000
- 试验地点
- 9
- 主要终点
- Blood pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Children less that 18 years of age
研究组 & 干预措施
Non-Practice Facilitation
implementation of the Kaiser Blood Pressure Control Bundle without Practice Facilitation
干预措施: Non-Practice Facilitation (Other)
Practice Facilitation
Practice Facilitation to support implementation of the Kaiser Blood Pressure Control Bundle
干预措施: Practice Facilitation (Other)
结局指标
主要结局
Blood pressure
时间窗: 3-6 months per patient
The investigators will examine change in systolic blood pressure measured via automatic and manual devices as a result of participating in the intervention
次要结局
- Acceptability of Intervention Measure(2 years)
- Feasibility of implementation(2 years)
研究者
Justin D. Smith
Adjunct Associate Professor
Northwestern University
