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Diabetes Mellitus, Non-Insulin-DependentNCT00160017

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

An observational study of Diabetes Mellitus, Non-Insulin-Dependent, run by Radboud University Medical Center at 52 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Non-Insulin-Dependent
What is being tested?
Breakthrough collaborative
How many people
1,861 participants
Where
52 sitesNetherlands
Study dates
Jan 2005to Mar 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • pregnancy
  • patients with a life expectancy < 1 year

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

Netherlands52 sites

  • Medisch Centrum Alkmaar

    Alkmaar, North Holland, 1815 JD

  • Huisartspraktijk1

    Alkmaar, North Holland, 1825 CJ

  • Huisartspraktijk24

    Amsterdam, North Holland, 1015 TV

  • St. Lucas Andreas Ziekenhuis

    Amsterdam, North Holland, 1061 AE

  • Huisartspraktijk29

    Amsterdam, North Holland, 1064 LG

  • Slotervaartziekenhuis, Maatschap Interne

    Amsterdam, North Holland, 1066 EC

  • Huisartspraktijk18

    Amsterdam, North Holland, 1066 PL

  • Huisartspraktijk20

    Amsterdam, North Holland, 1068 ML

  • Huisartspraktijk19

    Amsterdam, North Holland, 1068 NP

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1091 AC

  • Huisartspraktijk21

    Amsterdam, North Holland, 1091 EB

  • Huisartspraktijk23

    Amsterdam, North Holland, 1091 EB

  • Huisartspraktijk25

    Amsterdam, North Holland, 1092 AT

  • Huisartsenpraktijk Julianastraat14

    Asten, North Brabant, 5721 GK

  • Huisartspraktijk De Poort10

    Beuningen, North Brabant, 6641 BJ

  • Mesos Medisch Centrum

    Bilthoven, Utrecht, 3723 MB

  • Huisartspraktijk5

    Den Helder, North Holland, 1781 JP

  • Gemini Ziekenhuis

    Den Helder, North Holland, 1782 GZ

  • Gezondheidscentrum "De Schooten"6

    Den Helder, North Holland, 1785 RM

  • Praktijk Van Mechelen32

    Dinteloord, North Brabant, 4671 DA

  • Huisartspraktijk33

    Fijnaart, North Brabant, 4793 AW

  • St. Annaziekenhuis, Maatschap Interne Geneeskunde

    Geldrop, North Brabant, 5664 EH

  • Therapeuticum Lemminkäinen36

    Groningen, Provincie Groningen, 9712 VK

  • Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde

    Groningen, Provincie Groningen, 9713 GZ

  • Huisartspraktijk35

    Groningen, Provincie Groningen, 9714 DX

  • Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde

    Haarlem, North Holland, 2012 CE

  • Huisartsenpraktijk Scholten17

    Helmond, North Brabant, 5704 AP

  • Huisartsenpraktijk Dams15

    Helmond, North Brabant, 5704 CM

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

    Helmond, North Brabant, 5707 HA

  • Huisartsenpraktijk van den Nieuwenhof16

    Helmond, North Brabant, 5709 HX

  • Huisartspraktijk2

    Hoofddorp, South Holland, 2132 DW

  • Huisartspraktijk3

    Hoofddorp, South Holland, 2132 GB

  • Atrium Medisch Centrum, Polikliniek Interne Geneeskunde

    Kerkrade, Limburg, 6461 AL

  • Medisch Centrum Het Joppe8

    Leiden, South Holland, 2317 LV

  • Gezondheidscentrum Stevenshof4

    Leiden, South Holland, 2331 JE

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333 ZA

  • Diaconessenhuis

    Leiden, South Holland, 2334 CK

  • Huisartspraktijk27

    Limmen, North Holland, 1906 AW

  • Universitair Medisch Centrum St Radboud

    Nijmegen, Gelderland, 6525 GA

  • Huisartspraktijk28

    Nijmegen, Gelderland, 6525 ZD

  • Huisartspraktijk34

    Roosendaal, North Brabant, 4702 GJ

  • Huisartspraktijk31

    Roosendaal, North Brabant, 4702 NS

  • Huisartspraktijk13

    Roosendaal, North Brabant, 4702 XD

  • Huisartspraktijk Vincenten12

    Roosendaal, North Brabant, 4703 HZ

  • Huisartspraktijk30

    Roosendaal, North Brabant, 4706 BL

  • Huisartspraktijk26

    Schoorl, North Holland, 1871 ER

  • Huisartspraktijk22

    Someren, North Brabant, 5711 GV

  • Artsenpraktijk Ruiterstal11

    Steenbergen, North Brabant, 4651 ER

  • Gezondheidscentrum Kanaleneiland38

    Utrecht, Utrecht, 3527 GB

  • Huisartspraktijk Carnegiedreef37

    Utrecht, Utrecht, 3563 AA

  • Huisartspraktijk De Heelhoek9

    Wijchen, North Brabant, 6602 DD

  • Huisartspraktijk7

    Zuidhorn, Provincie Groningen, 9801 AD

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Breakthrough collaborative
Keywords
Quality assurance health care, Diabetes, Breakthrough collaborative (IHI), Evaluation
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breakthrough collaborativeBehavioural

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

Study groups in NCT00160017
Study groupRoleWhat they receive
Collaborative groupParticipants (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
Receives: Behavioral: Breakthrough collaborative
usual care groupParticipants are offered no intervention and care is provided as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Measured: baseline, after 12 months and after 24 months

Secondary outcomes (5)

  1. To improve the patient outcomes mentioned above, teams are supported:

    Measured: baseline, after 12 months and after 24 months

  2. (I) to introduce self-management of patients,

    Measured: baseline, after 12 months and after 24 months

  3. (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

    Measured: baseline, after 12 months and after 24 months

  4. (III) to introduce a system to administrate clinical parameters.

    Measured: baseline, after 12 months and after 24 months

  5. These intermediate outcomes will be measured as well, in both the intervention and the control group.

    Measured: baseline, after 12 months and after 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionMar 2008
  4. Study completionMar 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
1,861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00160017
Sponsor's protocol ID
Breakthrough_LoesSchouten
Other IDs
ZonMw grant no. 945-14-405
Status last verified
Nov 2015
First submitted
9 Sep 2005
Last updated
30 Nov 2015
Results posted
No

Publications

  • 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.

    PubMed 20808258

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Non-Insulin-Dependent, run by Radboud University Medical Center at 52 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: baseline, after 12 months and after 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00160017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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