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
  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: Observational
Study Design: Time Perspective: Prospective
Official Title: Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • HbA1c [ Time Frame: baseline, after 12 months and after 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1861
Study Start Date: January 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Behavioral: Breakthrough collaborative
Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care
usual care group
Participants are offered no intervention and care is provided as usual

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160017

  Show 52 Study Locations
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Dutch Institute for HealthCare Improvement (CBO)
College of Health Insurances CVZ
Investigators
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:
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: November 27, 2015
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 July 26, 2016