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OpenTrials
Completed

NCT Number: NCT00160017

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huisartspraktijk28, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breakthrough collaborative

Behavioral

Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care

Primary outcomes

  1. HbA1c

    Time frame: baseline, after 12 months and after 24 months

Secondary outcomes

  1. To improve the patient outcomes mentioned above, teams are supported:

    Time frame: baseline, after 12 months and after 24 months

  2. (I) to introduce self-management of patients,

    Time frame: baseline, after 12 months and after 24 months

  3. (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

  4. (III) to introduce a system to administrate clinical parameters.

    Time frame: baseline, after 12 months and after 24 months

  5. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • College of Health Insurances CVZ
  • Dutch Institute for HealthCare Improvement (CBO)
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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