Integrating Community Health Workers Into Primary Care Teams to Improve Diabetes Prevention in Underserved Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- Patient Activation Measure (PAM) scores
研究概览
简要总结
Cluster randomized trial to test the impact of peer health coaches on prediabetic patients. This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus, using low cost, culturally congruent personnel to promote prevention of Diabetes Mellitus in patient-centered medical home (PCMH) practice.
详细描述
This population based trial aims to understand the impact of peer health interventions on panels of patients in a real clinic environment
Investigators will conduct a cluster-randomized trial to test the impact of peer health coaches on prediabetic patients cared for by patient-centered medical home model (PCMH) teams to:
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Reduce the incidence of type 2 DM in pre-diabetic, PCMH patients;
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Promote weight loss among pre-diabetic patients;
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Increase patient activation levels, a measureable construct of engagement, efficacy, skills, and confidence in managing one's health, among pre-DM patients, resulting in:
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Improved secondary clinical outcomes: better glycemic and blood pressure control, and lower Framingham risk scores;
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Increased utilization of preventive services (e.g. MOVE!, TeleMOVE!, Healthy Lifestyles, etc);
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Improved health behaviors (e.g. making dietary and exercise changes); and
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Develop, implement and assess strategies to recruit, train, and integrate peer CHW health coaches within the PCMH model.
This study will test a scalable model of peer health coaching to address the millions of patients at risk for Diabetes Mellitus (DM),using low cost, culturally congruent personnel to promote prevention of DM in PCMH practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having at least one HbA1c result in the prediabetic range (5.7-6.5%) in the 5 years prior to the start date of Phase 2.
排除标准
- •A diagnosis of DM, based on ICD-9 codes applied during ambulatory encounters in the 2 years prior to Phase 2
- •Treatment with DM medication other than metformin (e.g. insulin or oral agents)
- •age greater than 75 years
- •exclusion by patient's PCP due to contraindication for lifestyle intervention or CHW outreach.
- •Does not speak English or Spanish (necessary to communicate with community health worker)
结局指标
主要结局
Patient Activation Measure (PAM) scores
时间窗: 36 Months
The PAM survey reliably predicts future ER visits, hospital admissions and readmissions, medication adherence and more.
Incidence rates of type 2 DM
时间窗: 36 Months
Cumulative DM incidence rates and time to DM incidence
Weight loss and obesity rates
时间窗: 36 Months
Will conduct chi-square test to compare DM incidence rates at 36-months follow-up of the intervention and control arms.
次要结局
未报告次要终点