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

Diabetes Mellitus, Non-Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160017
• Other study ID #: Breakthrough_LoesSchouten
• Secondary ID: ZonMw grant no.
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: November 27, 2015
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: November 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1861
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Non-Insulin-Dependent
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Breakthrough collaborative
Participants (professionals) participate in a Breakthrough Collaborative to improve diabetes care

Locations

Country	Name	City	State
Netherlands	Huisartspraktijk1	Alkmaar	Noord-Holland
Netherlands	Medisch Centrum Alkmaar	Alkmaar	Noord-Holland
Netherlands	Huisartspraktijk18	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk19	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk20	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk21	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk23	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk24	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk25	Amsterdam	Noord-Holland
Netherlands	Huisartspraktijk29	Amsterdam	Noord-Holland
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	Noord-Holland
Netherlands	Slotervaartziekenhuis, Maatschap Interne	Amsterdam	Noord-Holland
Netherlands	St. Lucas Andreas Ziekenhuis	Amsterdam	Noord-Holland
Netherlands	Huisartsenpraktijk Julianastraat14	Asten	Noord-Brabant
Netherlands	Huisartspraktijk De Poort10	Beuningen	Noord-Brabant
Netherlands	Mesos Medisch Centrum	Bilthoven	Utrecht
Netherlands	Gemini Ziekenhuis	Den Helder	Noord-Holland
Netherlands	Gezondheidscentrum "De Schooten"6	Den Helder	Noord-Holland
Netherlands	Huisartspraktijk5	Den Helder	Noord-Holland
Netherlands	Praktijk Van Mechelen32	Dinteloord	Noord-Brabant
Netherlands	Huisartspraktijk33	Fijnaart	Noord-Brabant
Netherlands	St. Annaziekenhuis, Maatschap Interne Geneeskunde	Geldrop	Noord-Brabant
Netherlands	Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde	Groningen
Netherlands	Huisartspraktijk35	Groningen
Netherlands	Therapeuticum Lemminkäinen36	Groningen
Netherlands	Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde	Haarlem	Noord-Holland
Netherlands	Huisartsenpraktijk Dams15	Helmond	Noord-Brabant
Netherlands	Huisartsenpraktijk Scholten17	Helmond	Noord-Brabant
Netherlands	Huisartsenpraktijk van den Nieuwenhof16	Helmond	Noord-Brabant
Netherlands	Quartz Transmuraal Centrum voor de Regio Helmond, Elkerliek ziekenhuis Provisorium 1e etage	Helmond	Noord-Brabant
Netherlands	Huisartspraktijk2	Hoofddorp	Zuid-Holland
Netherlands	Huisartspraktijk3	Hoofddorp	Zuid-Holland
Netherlands	Atrium Medisch Centrum, Polikliniek Interne Geneeskunde	Kerkrade	Limburg
Netherlands	Diaconessenhuis	Leiden	Zuid-Holland
Netherlands	Gezondheidscentrum Stevenshof4	Leiden	Zuid-Holland
Netherlands	Leids Universitair Medisch Centrum	Leiden	Zuid-Holland
Netherlands	Medisch Centrum Het Joppe8	Leiden	Zuid-Holland
Netherlands	Huisartspraktijk27	Limmen	Noord-Holland
Netherlands	Huisartspraktijk28	Nijmegen	Gelderland
Netherlands	Universitair Medisch Centrum St Radboud	Nijmegen	Gelderland
Netherlands	Huisartspraktijk Vincenten12	Roosendaal	Noord-Brabant
Netherlands	Huisartspraktijk13	Roosendaal	Noord-Brabant
Netherlands	Huisartspraktijk30	Roosendaal	Noord-Brabant
Netherlands	Huisartspraktijk31	Roosendaal	Noord-Brabant
Netherlands	Huisartspraktijk34	Roosendaal	Noord-Brabant
Netherlands	Huisartspraktijk26	Schoorl	Noord-Holland
Netherlands	Huisartspraktijk22	Someren	Noord-Brabant
Netherlands	Artsenpraktijk Ruiterstal11	Steenbergen	Noord-Brabant
Netherlands	Gezondheidscentrum Kanaleneiland38	Utrecht
Netherlands	Huisartspraktijk Carnegiedreef37	Utrecht
Netherlands	Huisartspraktijk De Heelhoek9	Wijchen	Noord-Brabant
Netherlands	Huisartspraktijk7	Zuidhorn	Groningen

Sponsors (4)

Lead Sponsor	Collaborator
Radboud University	College of Health Insurances CVZ, Dutch Institute for HealthCare Improvement (CBO), ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		baseline, after 12 months and after 24 months	No
Secondary	To improve the patient outcomes mentioned above, teams are supported:		baseline, after 12 months and after 24 months	No
Secondary	(I) to introduce self-management of patients,		baseline, after 12 months and after 24 months	No
Secondary	(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		baseline, after 12 months and after 24 months	No
Secondary	(III) to introduce a system to administrate clinical parameters.		baseline, after 12 months and after 24 months	No
Secondary	These intermediate outcomes will be measured as well, in both the intervention and the control group.		baseline, after 12 months and after 24 months	No

External Links

•   Information about the Centre for Quality of Care Research