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

This study has been completed.
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: November 27, 2015
Last verified: November 2015

September 9, 2005
November 27, 2015
January 2005
March 2008   (final data collection date for primary outcome measure)
HbA1c [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • (I) to introduce self-management of patients, [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]
  • (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 [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]
  • (III) to introduce a system to administrate clinical parameters. [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]
  • These intermediate outcomes will be measured as well, in both the intervention and the control group. [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]
  • * 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.
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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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

6 intervention and 9 control sites representing multiporfessional provider teams from 13 outpatient clinics (47 internists) and 37 general practices (42 general practitioners)

NB To assess the effects of the collaborative, patient outcomes, professional performance, and structural aspects of care management are measured. Patients visiting the clinics were invited to participate by filling out questionnaires and providing written consent to have their medical records examined. Below information on patient inclusion is provided.

Diabetes Mellitus, Non-Insulin-Dependent
Behavioral: Breakthrough collaborative
Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care
  • Collaborative group
    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
    Intervention: Behavioral: Breakthrough collaborative
  • usual care group
    Participants are offered no intervention and care is provided as usual
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. doi: 10.1097/MLR.0b013e3181eb318f.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1861
March 2008
March 2008   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00160017
Breakthrough_LoesSchouten, ZonMw grant no. 945-14-405
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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
November 2015

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