Clinical trial NCT00160017: Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative
Official title: Effectiveness and Cost-effectiveness of the Diabetes Integrated Care Breakthrough Collaborative to Improve Diabetes Care, Its Health Outcomes and Economic Costs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Quality assurance health care
Diabetes
Breakthrough collaborative (IHI)
Evaluation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Dutch Institute for HealthCare Improvement (CBO)
name: College of Health Insurances CVZ
First posted: 2005-09-12
Enrollment: 1861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

Brief 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.

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 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

Primary outcomes:
measure: HbA1c
timeFrame: baseline, after 12 months and after 24 months
Secondary outcomes:
measure: To improve the patient outcomes mentioned above, teams are supported:
timeFrame: baseline, after 12 months and after 24 months
measure: (I) to introduce self-management of patients,
timeFrame: baseline, after 12 months and after 24 months
measure: (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
timeFrame: baseline, after 12 months and after 24 months
measure: (III) to introduce a system to administrate clinical parameters.
timeFrame: baseline, after 12 months and after 24 months
measure: These intermediate outcomes will be measured as well, in both the intervention and the control group.
timeFrame: baseline, after 12 months and after 24 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St Radboud
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Huisartspraktijk28
state: Gelderland
city: Zuidhorn
country: Netherlands
facility: Huisartspraktijk7
state: Groningen
city: Kerkrade
country: Netherlands
facility: Atrium Medisch Centrum, Polikliniek Interne Geneeskunde
state: Limburg
city: Asten
country: Netherlands
facility: Huisartsenpraktijk Julianastraat14
state: Noord-Brabant
city: Beuningen
country: Netherlands
facility: Huisartspraktijk De Poort10
state: Noord-Brabant
city: Dinteloord
country: Netherlands
facility: Praktijk Van Mechelen32
state: Noord-Brabant
city: Fijnaart
country: Netherlands
facility: Huisartspraktijk33
state: Noord-Brabant
city: Geldrop
country: Netherlands
facility: St. Annaziekenhuis, Maatschap Interne Geneeskunde
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Huisartsenpraktijk Scholten17
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Huisartsenpraktijk Dams15
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Quartz Transmuraal Centrum voor de Regio Helmond, Elkerliek ziekenhuis Provisorium 1e etage
state: Noord-Brabant
city: Helmond
country: Netherlands
facility: Huisartsenpraktijk van den Nieuwenhof16
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Huisartspraktijk34
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Huisartspraktijk31
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Huisartspraktijk13
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Huisartspraktijk Vincenten12
state: Noord-Brabant
city: Roosendaal
country: Netherlands
facility: Huisartspraktijk30
state: Noord-Brabant
city: Someren
country: Netherlands
facility: Huisartspraktijk22
state: Noord-Brabant
city: Steenbergen
country: Netherlands
facility: Artsenpraktijk Ruiterstal11
state: Noord-Brabant
city: Wijchen
country: Netherlands
facility: Huisartspraktijk De Heelhoek9
state: Noord-Brabant
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
state: Noord-Holland
city: Alkmaar
country: Netherlands
facility: Huisartspraktijk1
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk24
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: St. Lucas Andreas Ziekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk29
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Slotervaartziekenhuis, Maatschap Interne
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk18
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk20
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk19
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk21
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk23
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Huisartspraktijk25
state: Noord-Holland
city: Den Helder
country: Netherlands
facility: Huisartspraktijk5
state: Noord-Holland
city: Den Helder
country: Netherlands
facility: Gemini Ziekenhuis
state: Noord-Holland
city: Den Helder
country: Netherlands
facility: Gezondheidscentrum "De Schooten"6
state: Noord-Holland
city: Haarlem
country: Netherlands
facility: Spaarne Ziekenhuis, Afdeling Inwendige Geneeskunde
state: Noord-Holland
city: Limmen
country: Netherlands
facility: Huisartspraktijk27
state: Noord-Holland
city: Schoorl
country: Netherlands
facility: Huisartspraktijk26
state: Noord-Holland
city: Bilthoven
country: Netherlands
facility: Mesos Medisch Centrum
state: Utrecht
city: Hoofddorp
country: Netherlands
facility: Huisartspraktijk2
state: Zuid-Holland
city: Hoofddorp
country: Netherlands
facility: Huisartspraktijk3
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Medisch Centrum Het Joppe8
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Gezondheidscentrum Stevenshof4
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-Holland
city: Leiden
country: Netherlands
facility: Diaconessenhuis
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: Therapeuticum Lemminkäinen36
city: Groningen
country: Netherlands
facility: Academisch Ziekenhuis Groningen, Afdeling Inwendige Geneeskunde
city: Groningen
country: Netherlands
facility: Huisartspraktijk35
city: Utrecht
country: Netherlands
facility: Gezondheidscentrum Kanaleneiland38
city: Utrecht
country: Netherlands
facility: Huisartspraktijk Carnegiedreef37
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research
name: Marlies E.J.L. Hulscher, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG)
name: Louis W. Niessen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Centre, Centre for Quality of Care Research
name: Richard PTM Grol, Prof.
role: STUDY_DIRECTOR
affiliation: Erasmus Institute for Medical Technology Assessment, Institute of Health Policy and Management (iBMG)
name: Robbert Huijsman, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.