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

NCT ID: NCT00160017

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1861 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Non-Insulin-Dependent

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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

Breakthrough collaborative

Intervention Type BEHAVIORAL

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

No interventions assigned to this group

Interventions

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Breakthrough collaborative

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Dutch Institute for HealthCare Improvement (CBO)

UNKNOWN

Sponsor Role collaborator

College of Health Insurances CVZ

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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Marlies E.J.L. Hulscher, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research

Louis W. Niessen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG)

Richard PTM Grol, Prof.

Role: STUDY_DIRECTOR

Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research

Robbert Huijsman, Prof.

Role: STUDY_DIRECTOR

Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG)

Locations

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Universitair Medisch Centrum St Radboud

Nijmegen, Gelderland, Netherlands

Site Status

Huisartspraktijk28

Nijmegen, Gelderland, Netherlands

Site Status

Atrium Medisch Centrum, Polikliniek Interne Geneeskunde

Kerkrade, Limburg, Netherlands

Site Status

Huisartsenpraktijk Julianastraat14

Asten, North Brabant, Netherlands

Site Status

Huisartspraktijk De Poort10

Beuningen, North Brabant, Netherlands

Site Status

Praktijk Van Mechelen32

Dinteloord, North Brabant, Netherlands

Site Status

Huisartspraktijk33

Fijnaart, North Brabant, Netherlands

Site Status

St. Annaziekenhuis, Maatschap Interne Geneeskunde

Geldrop, North Brabant, Netherlands

Site Status

Huisartsenpraktijk Scholten17

Helmond, North Brabant, Netherlands

Site Status

Huisartsenpraktijk Dams15

Helmond, North Brabant, Netherlands

Site Status

Quartz Transmuraal Centrum voor de Regio Helmond, Elkerliek ziekenhuis Provisorium 1e etage

Helmond, North Brabant, Netherlands

Site Status

Huisartsenpraktijk van den Nieuwenhof16

Helmond, North Brabant, Netherlands

Site Status

Huisartspraktijk34

Roosendaal, North Brabant, Netherlands

Site Status

Huisartspraktijk31

Roosendaal, North Brabant, Netherlands

Site Status

Huisartspraktijk13

Roosendaal, North Brabant, Netherlands

Site Status

Huisartspraktijk Vincenten12

Roosendaal, North Brabant, Netherlands

Site Status

Huisartspraktijk30

Roosendaal, North Brabant, Netherlands

Site Status

Huisartspraktijk22

Someren, North Brabant, Netherlands

Site Status

Artsenpraktijk Ruiterstal11

Steenbergen, North Brabant, Netherlands

Site Status

Huisartspraktijk De Heelhoek9

Wijchen, North Brabant, Netherlands

Site Status

Medisch Centrum Alkmaar

Alkmaar, North Holland, Netherlands

Site Status

Huisartspraktijk1

Alkmaar, North Holland, Netherlands

Site Status

Huisartspraktijk24

Amsterdam, North Holland, Netherlands

Site Status

St. Lucas Andreas Ziekenhuis

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk29

Amsterdam, North Holland, Netherlands

Site Status

Slotervaartziekenhuis, Maatschap Interne

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk18

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk20

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk19

Amsterdam, North Holland, Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk21

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk23

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk25

Amsterdam, North Holland, Netherlands

Site Status

Huisartspraktijk5

Den Helder, North Holland, Netherlands

Site Status

Gemini Ziekenhuis

Den Helder, North Holland, Netherlands

Site Status

Gezondheidscentrum "De Schooten"6

Den Helder, North Holland, Netherlands

Site Status

Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde

Haarlem, North Holland, Netherlands

Site Status

Huisartspraktijk27

Limmen, North Holland, Netherlands

Site Status

Huisartspraktijk26

Schoorl, North Holland, Netherlands

Site Status

Therapeuticum Lemminkäinen36

Groningen, Provincie Groningen, Netherlands

Site Status

Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde

Groningen, Provincie Groningen, Netherlands

Site Status

Huisartspraktijk35

Groningen, Provincie Groningen, Netherlands

Site Status

Huisartspraktijk7

Zuidhorn, Provincie Groningen, Netherlands

Site Status

Huisartspraktijk2

Hoofddorp, South Holland, Netherlands

Site Status

Huisartspraktijk3

Hoofddorp, South Holland, Netherlands

Site Status

Medisch Centrum Het Joppe8

Leiden, South Holland, Netherlands

Site Status

Gezondheidscentrum Stevenshof4

Leiden, South Holland, Netherlands

Site Status

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Site Status

Diaconessenhuis

Leiden, South Holland, Netherlands

Site Status

Mesos Medisch Centrum

Bilthoven, Utrecht, Netherlands

Site Status

Gezondheidscentrum Kanaleneiland38

Utrecht, Utrecht, Netherlands

Site Status

Huisartspraktijk Carnegiedreef37

Utrecht, Utrecht, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 20808258 (View on PubMed)

Related Links

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http://www.wokresearch.nl

Information about the Centre for Quality of Care Research

Other Identifiers

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ZonMw grant no. 945-14-405

Identifier Type: -

Identifier Source: secondary_id

Breakthrough_LoesSchouten

Identifier Type: -

Identifier Source: org_study_id