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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Radboud University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Institute for HealthCare Improvement (CBO)
College of Health Insurances CVZ
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00160017
First received: September 9, 2005
Last updated: May 7, 2008
Last verified: May 2008

September 9, 2005
May 7, 2008
January 2005
Not Provided
HbA1c [ Time Frame: baseline, after 12 months and after 24 months ]
HbA1c at baseline, after 12 months and after 24 months
Complete list of historical versions of study NCT00160017 on ClinicalTrials.gov Archive Site
  • 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.
  • * blood pressure and cholesterol levels at baseline, after 12 months and after 24 months
  • To improve the patient outcomes mentioned above, teams are supported:
  • (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.
Not Provided
Not Provided
 
Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative
Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Diabetes Mellitus, Non-Insulin-Dependent
Behavioral: Breakthrough collaborative
Not Provided
Schouten LM, Niessen LW, van de Pas JW, Grol RP, Hulscher ME. Cost-effectiveness of a quality improvement collaborative focusing on patients with diabetes. Med Care. 2010 Oct;48(10):884-91.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1800
March 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00160017
Breakthrough_LoesSchouten, ZonMw grant no. 945-14-405
Not Provided
Not Provided
Radboud University
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Dutch Institute for HealthCare Improvement (CBO)
  • College of Health Insurances CVZ
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)
Radboud University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP