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临床试验/NCT00436176
NCT00436176已完成3 期

The Expanded Chronic Care Model: Targeting Disparities in Diabetes Care

Harvard Vanguard Medical Associates2 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
6,000
试验地点
2
主要终点
Rate of LDL cholesterol control (< 100 mg/dL)

研究概览

简要总结

The goal of this study is to investigate methods of improving diabetes care for African Americans in primary care clinics. Primary care clinicians will receive training in the delivery of cross-cultural medicine as well as regular performance feedback reports.

详细描述

Effective solutions are needed to address the parallel persistence of a quality chasm and racial disparities in diabetes care. Many large health care systems are adopting components of the Chronic Care Model to achieve substantial gains in diabetes care, though few health systems have successfully incorporated elements specific to minority health. We have previously identified racial disparities in key diabetes outcomes measures within an integrated health care delivery system, Harvard Vanguard Medical Associates (HVMA). This project will use a randomized, controlled study design within HVMA to evaluate whether enhancements to the Chronic Care Model can produce significant improvement in the quality of diabetes care for black patients. Intervention clinicians will receive monthly panel-level disparities report cards, health navigation training, and cultural competency training, while control clinicians will function within the context of the generic Chronic Care Model. The study will occur over a 12 month period and involve 4,000 white patients and 2,500 black patients with diabetes receiving care at 8 health centers. The primary outcomes will include rates of glucose (HbA1c <7.0), LDL cholesterol (<100 mg/dL), and blood pressure (<130/80) control. We will use patient focus groups to identify significant barriers to care and guide health navigation training. We will survey clinicians pre- and post intervention to assess the effect of the intervention on knowledge and attitudes towards disparities. Patient experiences will be assessed pre- and post-intervention using a validated instrument to determine whether the intervention can reduce existing racial disparities in patient reports of quality. We will perform a cost analysis related to the intervention using a health system perspective. In summary, this project will provide health systems with a rigorous analysis of a defined set of tools to improve diabetes care for minority populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of diabetes mellitus (based on fasting glucose, HbA1c, and problem list)
  • At least 18 years old
  • At least one face-to-face visit with Harvard Vanguard primary care clinician in the last 2 years

排除标准

  • Any patient not categorized as either White or Black based on race identifier in the electronic medical record

结局指标

主要结局

Rate of LDL cholesterol control (< 100 mg/dL)

时间窗: 12 months

Rate of blood pressure control (< 130/80 mmHg)

时间窗: 12 months

Rate of HbA1c control (<7%)

时间窗: 12 months

次要结局

  • Rate of HbA1c control (<8%)(12 months)
  • Rate of LDL cholesterol control (< 130 mg/dL)(12 months)
  • Rate of blood pressure control (< 140/90 mmHg)(12 months)

研究者

申办方类型
Other

研究点 (2)

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