Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Behavioral: Breakthrough collaborative |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
| Official Title: | Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs |
- HbA1c [ Time Frame: baseline, after 12 months and after 24 months ]
- To improve the patient outcomes mentioned above, teams are supported: [ Time Frame: baseline, after 12 months and after 24 months ]
- (I) to introduce self-management of patients,
- (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
- (III) to introduce a system to administrate clinical parameters.
- These intermediate outcomes will be measured as well, in both the intervention and the control group.
| Estimated Enrollment: | 1800 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | March 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 52 Study Locations| Principal Investigator: | Marlies E.J.L. Hulscher, MSc, PhD | Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research |
| Principal Investigator: | Louis W. Niessen, MD, PhD | Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG) |
| Study Director: | Richard PTM Grol, Prof. | Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research |
| Study Director: | Robbert Huijsman, Prof. | Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG) |
More Information
Additional Information:
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00160017 History of Changes |
| Other Study ID Numbers: | Breakthrough_LoesSchouten, ZonMw grant no. 945-14-405 |
| Study First Received: | September 9, 2005 |
| Last Updated: | May 7, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Quality assurance health care Diabetes Breakthrough collaborative (IHI) Evaluation |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013