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临床试验/NCT00160017
NCT00160017已完成不适用

Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs

Radboud University Medical Center52 个研究点 分布在 1 个国家目标入组 1,861 人开始时间: 2005年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,861
试验地点
52
主要终点
HbA1c

研究概览

简要总结

The study tests whether implementing professional evidence-based guidelines and best practices for diabetes care -through participation of multidisciplinary teams in a Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs. Determinants of success are studied. Data on diabetes will also be used to better understand Breakthrough as an implementation or improvement method.

详细描述

Diabetes mellitus as a chronic disease is a major and growing health care problem. Studies on the prevention of severe complications provide evidence for the necessity of tight control. Different interventions and models to achieve strict control and reduce diabetes related risks of complications are available. These are, however, not implemented in daily practice. Our study focuses on this implementation problem: it tests whether implementing professional evidence-based guidelines and best practices -through participation of multidisciplinary teams in the Breakthrough collaborative- results in an improvement of diabetes care, its health outcomes and economic costs.

Data on diabetes will also be used to explore and better understand the Breakthrough model as an implementation method. Only uncontrolled observational studies have, so far, described the outcomes of Breakthrough collaboratives. They also describe significant differences between teams in specific improvements made in patient care and organisational performance, resulting in different implementation and medical costs. There is hardly any information regarding these costs and the cost-effectiveness of collaboratives, and little knowledge about how they could be made more effective. Insight is also needed into the factors that influence the success of individual teams. There are no data regarding the sustainability of improvements.

研究设计

研究类型
Observational
时间视角
Prospective

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

  • each patient, male or female, visiting the hospital outpatient clinic or general practice with type II diabetes mellitus during a specified period. Patients should be able to read and write the Dutch language.

排除标准

  • pregnancy
  • patients with a life expectancy < 1 year

结局指标

主要结局

HbA1c

时间窗: baseline, after 12 months and after 24 months

次要结局

  • (I) to introduce self-management of patients,(baseline, after 12 months and after 24 months)
  • (II) to change professional performance and the organisation of care (by implementing guidelines and local protocols focusing on the prevention of severe complications and introducing diabetes nurses) and(baseline, after 12 months and after 24 months)
  • (III) to introduce a system to administrate clinical parameters.(baseline, after 12 months and after 24 months)
  • These intermediate outcomes will be measured as well, in both the intervention and the control group.(baseline, after 12 months and after 24 months)
  • To improve the patient outcomes mentioned above, teams are supported:(baseline, after 12 months and after 24 months)

研究者

申办方类型
Other

研究点 (52)

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