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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
  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: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Effectiveness and Cost-Effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs

Resource links provided by NLM:


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
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

  Hide Study Locations
Locations
Netherlands
Huisartspraktijk28
Nijmegen, Gelderland, Netherlands, 6525 ZD
Universitair Medisch Centrum St Radboud
Nijmegen, Gelderland, Netherlands, 6525 GA
Huisartspraktijk7
Zuidhorn, Groningen, Netherlands, 9801 AD
Atrium Medisch Centrum, Polikliniek Interne Geneeskunde
Kerkrade, Limburg, Netherlands, 6461 AL
Huisartsenpraktijk Julianastraat14
Asten, Noord-Brabant, Netherlands, 5721 GK
Huisartspraktijk De Poort10
Beuningen, Noord-Brabant, Netherlands, 6641 BJ
Praktijk Van Mechelen32
Dinteloord, Noord-Brabant, Netherlands, 4671 DA
Huisartspraktijk33
Fijnaart, Noord-Brabant, Netherlands, 4793 AW
St. Annaziekenhuis, Maatschap Interne Geneeskunde
Geldrop, Noord-Brabant, Netherlands, 5664 EH
Quartz Transmuraal Centrum voor de Regio Helmond, Elkerliek ziekenhuis Provisorium 1e etage
Helmond, Noord-Brabant, Netherlands, 5707 HA
Huisartsenpraktijk Scholten17
Helmond, Noord-Brabant, Netherlands, 5704 AP
Huisartsenpraktijk van den Nieuwenhof16
Helmond, Noord-Brabant, Netherlands, 5709 HX
Huisartsenpraktijk Dams15
Helmond, Noord-Brabant, Netherlands, 5704 CM
Huisartspraktijk34
Roosendaal, Noord-Brabant, Netherlands, 4702 GJ
Huisartspraktijk Vincenten12
Roosendaal, Noord-Brabant, Netherlands, 4703 HZ
Huisartspraktijk30
Roosendaal, Noord-Brabant, Netherlands, 4706 BL
Huisartspraktijk31
Roosendaal, Noord-Brabant, Netherlands, 4702 NS
Huisartspraktijk13
Roosendaal, Noord-Brabant, Netherlands, 4702 XD
Huisartspraktijk22
Someren, Noord-Brabant, Netherlands, 5711 GV
Artsenpraktijk Ruiterstal11
Steenbergen, Noord-Brabant, Netherlands, 4651 ER
Huisartspraktijk De Heelhoek9
Wijchen, Noord-Brabant, Netherlands, 6602 DD
Huisartspraktijk1
Alkmaar, Noord-Holland, Netherlands, 1825 CJ
Medisch Centrum Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1815 JD
St. Lucas Andreas Ziekenhuis
Amsterdam, Noord-Holland, Netherlands, 1061 AE
Huisartspraktijk19
Amsterdam, Noord-Holland, Netherlands, 1068 NP
Huisartspraktijk20
Amsterdam, Noord-Holland, Netherlands, 1068 ML
Huisartspraktijk21
Amsterdam, Noord-Holland, Netherlands, 1091 EB
Huisartspraktijk23
Amsterdam, Noord-Holland, Netherlands, 1091 EB
Huisartspraktijk24
Amsterdam, Noord-Holland, Netherlands, 1015 TV
Huisartspraktijk25
Amsterdam, Noord-Holland, Netherlands, 1092 AT
Huisartspraktijk29
Amsterdam, Noord-Holland, Netherlands, 1064 LG
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord-Holland, Netherlands, 1091 AC
Slotervaartziekenhuis, Maatschap Interne
Amsterdam, Noord-Holland, Netherlands, 1066 EC
Huisartspraktijk18
Amsterdam, Noord-Holland, Netherlands, 1066 PL
Gemini Ziekenhuis
Den Helder, Noord-Holland, Netherlands, 1782 GZ
Gezondheidscentrum "De Schooten"6
Den Helder, Noord-Holland, Netherlands, 1785 RM
Huisartspraktijk5
Den Helder, Noord-Holland, Netherlands, 1781 JP
Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde
Haarlem, Noord-Holland, Netherlands, 2012 CE
Huisartspraktijk27
Limmen, Noord-Holland, Netherlands, 1906 AW
Huisartspraktijk26
Schoorl, Noord-Holland, Netherlands, 1871 ER
Mesos Medisch Centrum
Bilthoven, Utrecht, Netherlands, 3723 MB
Huisartspraktijk3
Hoofddorp, Zuid-Holland, Netherlands, 2132 GB
Huisartspraktijk2
Hoofddorp, Zuid-Holland, Netherlands, 2132 DW
Medisch Centrum Het Joppe8
Leiden, Zuid-Holland, Netherlands, 2317 LV
Diaconessenhuis
Leiden, Zuid-Holland, Netherlands, 2334 CK
Leids Universitair Medisch Centrum
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Gezondheidscentrum Stevenshof4
Leiden, Zuid-Holland, Netherlands, 2331 JE
Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde
Groningen, Netherlands, 9713 GZ
Huisartspraktijk35
Groningen, Netherlands, 9714 DX
Therapeuticum Lemminkäinen36
Groningen, Netherlands, 9712 VK
Gezondheidscentrum Kanaleneiland38
Utrecht, Netherlands, 3527 GB
Huisartspraktijk Carnegiedreef37
Utrecht, Netherlands, 3563 AA
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:
No publications provided by Radboud University

Additional 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: May 7, 2008
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014