Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Non-Insulin-Dependent

Intervention / Treatment
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* Behavioral: Breakthrough collaborative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: pregnancy patients with a life expectancy < 1 year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Collaborative group<br>Participants (i.e. profesionals) participate in a Breakthrough Collaborative intervention to improve diabetes care so that patients are provided more often with diabetes care as described in guidelines | Behavioral: Breakthrough collaborative<br>* Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care<br>|
| usual care group<br>Participants are offered no intervention and care is provided as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | baseline, after 12 months and after 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To improve the patient outcomes mentioned above, teams are supported: |  | baseline, after 12 months and after 24 months | 
| (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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality assurance health care, Diabetes, Breakthrough collaborative (IHI), Evaluation