Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative - Full Text View

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
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00160017

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

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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 ]

Secondary Outcome Measures:

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

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Information about the Centre for Quality of Care Research This link exits the ClinicalTrials.gov site

Study ID Numbers:	Breakthrough_LoesSchouten, ZonMw grant no. 945-14-405
Study First Received:	September 9, 2005
Last Updated:	May 7, 2008
ClinicalTrials.gov Identifier:	NCT00160017
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

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009