Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative
November 27, 2015 updated by: Radboud University Medical Center
Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
1861
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Groningen, Netherlands, 9712 VK
- Therapeuticum Lemminkäinen36
-
Groningen, Netherlands, 9713 GZ
- Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde
-
Groningen, Netherlands, 9714 DX
- Huisartspraktijk35
-
Utrecht, Netherlands, 3527 GB
- Gezondheidscentrum Kanaleneiland38
-
Utrecht, Netherlands, 3563 AA
- Huisartspraktijk Carnegiedreef37
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Universitair Medisch Centrum st Radboud
-
Nijmegen, Gelderland, Netherlands, 6525 ZD
- Huisartspraktijk28
-
-
Groningen
-
Zuidhorn, Groningen, Netherlands, 9801 AD
- Huisartspraktijk7
-
-
Limburg
-
Kerkrade, Limburg, Netherlands, 6461 AL
- Atrium Medisch Centrum, Polikliniek Interne Geneeskunde
-
-
Noord-Brabant
-
Asten, Noord-Brabant, Netherlands, 5721 GK
- Huisartsenpraktijk Julianastraat14
-
Beuningen, Noord-Brabant, Netherlands, 6641 BJ
- Huisartspraktijk De Poort10
-
Dinteloord, Noord-Brabant, Netherlands, 4671 DA
- Praktijk Van Mechelen32
-
Fijnaart, Noord-Brabant, Netherlands, 4793 AW
- Huisartspraktijk33
-
Geldrop, Noord-Brabant, Netherlands, 5664 EH
- St. Annaziekenhuis, Maatschap Interne Geneeskunde
-
Helmond, Noord-Brabant, Netherlands, 5704 AP
- Huisartsenpraktijk Scholten17
-
Helmond, Noord-Brabant, Netherlands, 5704 CM
- Huisartsenpraktijk Dams15
-
Helmond, Noord-Brabant, Netherlands, 5707 HA
- Quartz Transmuraal Centrum voor de Regio Helmond, Elkerliek ziekenhuis Provisorium 1e etage
-
Helmond, Noord-Brabant, Netherlands, 5709 HX
- Huisartsenpraktijk van den Nieuwenhof16
-
Roosendaal, Noord-Brabant, Netherlands, 4702 GJ
- Huisartspraktijk34
-
Roosendaal, Noord-Brabant, Netherlands, 4702 NS
- Huisartspraktijk31
-
Roosendaal, Noord-Brabant, Netherlands, 4702 XD
- Huisartspraktijk13
-
Roosendaal, Noord-Brabant, Netherlands, 4703 HZ
- Huisartspraktijk Vincenten12
-
Roosendaal, Noord-Brabant, Netherlands, 4706 BL
- Huisartspraktijk30
-
Someren, Noord-Brabant, Netherlands, 5711 GV
- Huisartspraktijk22
-
Steenbergen, Noord-Brabant, Netherlands, 4651 ER
- Artsenpraktijk Ruiterstal11
-
Wijchen, Noord-Brabant, Netherlands, 6602 DD
- Huisartspraktijk De Heelhoek9
-
-
Noord-Holland
-
Alkmaar, Noord-Holland, Netherlands, 1815 JD
- Medisch Centrum Alkmaar
-
Alkmaar, Noord-Holland, Netherlands, 1825 CJ
- Huisartspraktijk1
-
Amsterdam, Noord-Holland, Netherlands, 1015 TV
- Huisartspraktijk24
-
Amsterdam, Noord-Holland, Netherlands, 1061 AE
- St. Lucas Andreas Ziekenhuis
-
Amsterdam, Noord-Holland, Netherlands, 1064 LG
- Huisartspraktijk29
-
Amsterdam, Noord-Holland, Netherlands, 1066 EC
- Slotervaartziekenhuis, Maatschap Interne
-
Amsterdam, Noord-Holland, Netherlands, 1066 PL
- Huisartspraktijk18
-
Amsterdam, Noord-Holland, Netherlands, 1068 ML
- Huisartspraktijk20
-
Amsterdam, Noord-Holland, Netherlands, 1068 NP
- Huisartspraktijk19
-
Amsterdam, Noord-Holland, Netherlands, 1091 AC
- Onze Lieve Vrouwe Gasthuis
-
Amsterdam, Noord-Holland, Netherlands, 1091 EB
- Huisartspraktijk21
-
Amsterdam, Noord-Holland, Netherlands, 1091 EB
- Huisartspraktijk23
-
Amsterdam, Noord-Holland, Netherlands, 1092 AT
- Huisartspraktijk25
-
Den Helder, Noord-Holland, Netherlands, 1781 JP
- Huisartspraktijk5
-
Den Helder, Noord-Holland, Netherlands, 1782 GZ
- Gemini Ziekenhuis
-
Den Helder, Noord-Holland, Netherlands, 1785 RM
- Gezondheidscentrum "De Schooten"6
-
Haarlem, Noord-Holland, Netherlands, 2012 CE
- Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde
-
Limmen, Noord-Holland, Netherlands, 1906 AW
- Huisartspraktijk27
-
Schoorl, Noord-Holland, Netherlands, 1871 ER
- Huisartspraktijk26
-
-
Utrecht
-
Bilthoven, Utrecht, Netherlands, 3723 MB
- Mesos Medisch Centrum
-
-
Zuid-Holland
-
Hoofddorp, Zuid-Holland, Netherlands, 2132 DW
- Huisartspraktijk2
-
Hoofddorp, Zuid-Holland, Netherlands, 2132 GB
- Huisartspraktijk3
-
Leiden, Zuid-Holland, Netherlands, 2333 ZA
- Leids Universitair Medisch Centrum
-
Leiden, Zuid-Holland, Netherlands, 2317 LV
- Medisch Centrum Het Joppe8
-
Leiden, Zuid-Holland, Netherlands, 2331 JE
- Gezondheidscentrum Stevenshof4
-
Leiden, Zuid-Holland, Netherlands, 2334 CK
- Diaconessenhuis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HbA1c
Time Frame: baseline, after 12 months and after 24 months
|
baseline, after 12 months and after 24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To improve the patient outcomes mentioned above, teams are supported:
Time Frame: baseline, after 12 months and after 24 months
|
baseline, after 12 months and after 24 months
|
|
(I) to introduce self-management of patients,
Time Frame: baseline, after 12 months and after 24 months
|
baseline, after 12 months and after 24 months
|
|
(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
|
baseline, after 12 months and after 24 months
|
|
(III) to introduce a system to administrate clinical parameters.
Time Frame: baseline, after 12 months and after 24 months
|
baseline, after 12 months and after 24 months
|
|
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
|
baseline, after 12 months and after 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 30, 2015
Last Update Submitted That Met QC Criteria
November 27, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breakthrough_LoesSchouten
- ZonMw grant no. 945-14-405
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.