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Diabetes Care Implementation Study.


- candidate number2480
- NTR NumberNTR915
- ISRCTNISRCTN21523044
- Date ISRCTN created2-mei-2007
- date ISRCTN requested20-apr-2007
- Date Registered NTR20-feb-2007
- Secondary IDs 
- Public TitleDiabetes Care Implementation Study.
- Scientific TitleDiabetes Care Implementation Study.
- ACRONYMDIS
- hypothesisDiabetes care can be improved by task dellegation to a practice nurse supported by computerised decision support and benchmarking.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus type 2 (DM type II), Primary care, Decision Support System (Clinical), Quality of Health Care
- Inclusion criteriaDiabetes mellitus type 2.
- Exclusion criteria1. Under treatment of medical specialist;
2. Terminally ill patients;
3. Patients with complex multi morbidity;
4. Patients not able to visit the general practice.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2004
- planned closingdate30-mei-2007
- Target number of participants3500
- InterventionsImplementing the diabetes care protocol (DCP) developed by Diagnosis 4 Health.
Characteristics: consultationhour exclusively scheduled for DM2 patients and delegation of routine diabetes care tasks to a trained practice nurse who uses the DCP software that supports management and medical decisions.
- Primary outcome1. Change in:
a. HbA1c%;
b. Blood pressure;
c. Total cholesterol.
- Secondary outcome1. Change in cardiovascular risk;
2. Effects on quality of life and patient treatment satisfaction;
3. Effects on proces of care.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD F.G.W. Cleveringa
- CONTACT for SCIENTIFIC QUERIESMD F.G.W. Cleveringa
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care
- PublicationsN/A
- Brief summaryThe quality of care for patient with type 2 diabetes mellitus (DM2) in the Netherlands is still not optimal.
About 30% of these patients do not meet target values for blood glucose as recommended in the national guide lines.
Patients with diabetes have a 2-3 times increased risk for cardiovascular disease. When all cardiovascular risk factors, blood pressure and cholesterol are treated adequately, in time this will lead to less diabetes related complications. There have been many projects on improving care for patient with diabetes. Beside these projects, guidelines have been developed to improve the quality of diabetes care. Most projects were only temporary and often there is insufficient support for implementation in daily primary care practice. Diagnosis4Health (D4H) developed the Diabetes Care Protocol (DCP) in order to optimise diabetes care in general practice. DCP consist of a computerised decision support system, delegating routine task in diabetes care to a practice nurse, and starting a categorical diabetes consultation hour under responsibility of the primary care physician. Every three months the primary care physician becomes benchmark information. DCP is based on the Dutch primary care guidelines on diabetes mellitus type 2.

Aim of the study:
To study the effectiveness of the Diabetes Care Protocol as it is implemented by Diagnosis4Health.

Methods:
DIS is a cluster randomised intervention trial in 55 primary care practices. In 25 practices the Diabetes Care Protocol is implemented, the other 30 practices form the control group. They perform usual diabetes care. After one year DCP is also implemented in the control group.

Population:
Patients with type 2 diabetes mellitus treated by their primary care physician and able to visit the primary care practice.

Intervention:
Implementation of the Diabetes Care Protocol. The primary care practices are analysed to make a practice improvement plan. These improvements are necessary for optimal diabetes care. The practice nurse is schooled in performing a categorical diabetes consultation hour, and in using the computerised decision support DCP software. Every three month the primary care physician becomes benchmark information.

Primary endpoint:
Change in cardiovascular risk (factors): HbA1c, blood pressure and cholesterol.

Secondary endpoints:
Changes in process of care, quality of life, and quality of care.

Possible profits:
Improvement in quality of care, with improvements in primary endpoint.
Improvement in quality of life for patients with type 2 diabetes mellitus with equal or improved satisfaction about the quality of care.
This method, delegating routine chronic care to a practice nurse, using computerised decision support, may be used for other chronic illnesses. (COPD and/or cardio vascular disease)
- Main changes (audit trail)
- RECORD20-feb-2007 - 1-dec-2009


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