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

Completed

• Conditions: Diabetes Mellitus, Non-Insulin-Dependent

• Registration Number: NCT00160017
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-27
• Last Update Posted: 2015-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1861

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c	baseline, after 12 months and after 24 months

Secondary Outcome Measures

Name	Time	Method
(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

Trial Locations

Locations (52)

Universitair Medisch Centrum St Radboud; 🇳🇱 Nijmegen, Gelderland, Netherlands

Huisartspraktijk28; 🇳🇱 Nijmegen, Gelderland, Netherlands

Huisartspraktijk7; 🇳🇱 Zuidhorn, Groningen, Netherlands

Atrium Medisch Centrum, Polikliniek Interne Geneeskunde; 🇳🇱 Kerkrade, Limburg, Netherlands

Huisartsenpraktijk Julianastraat14; 🇳🇱 Asten, Noord-Brabant, Netherlands

Huisartspraktijk De Poort10; 🇳🇱 Beuningen, Noord-Brabant, Netherlands

Praktijk Van Mechelen32; 🇳🇱 Dinteloord, Noord-Brabant, Netherlands

Huisartspraktijk33; 🇳🇱 Fijnaart, Noord-Brabant, Netherlands

St. Annaziekenhuis, Maatschap Interne Geneeskunde; 🇳🇱 Geldrop, Noord-Brabant, Netherlands

Huisartsenpraktijk Scholten17; 🇳🇱 Helmond, Noord-Brabant, Netherlands

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