|- candidate number||2480|
|- NTR Number||NTR915|
|- Date ISRCTN created||2-mei-2007|
|- date ISRCTN requested||20-apr-2007|
|- Date Registered NTR||20-feb-2007|
|- Secondary IDs|| |
|- Public Title||Diabetes Care Implementation Study.|
|- Scientific Title||Diabetes Care Implementation Study.|
|- hypothesis||Diabetes care can be improved by task dellegation to a practice nurse supported by computerised decision support and benchmarking.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus type 2 (DM type II), Primary care, Decision Support System (Clinical), Quality of Health Care|
|- Inclusion criteria||Diabetes mellitus type 2.
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2004|
|- planned closingdate||30-mei-2007|
|- Target number of participants||3500|
|- Interventions||Implementing 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 outcome||1. Change in:|
b. Blood pressure;
c. Total cholesterol.
|- Secondary outcome||1. Change in cardiovascular risk;|
2. Effects on quality of life and patient treatment satisfaction;
3. Effects on proces of care.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MD F.G.W. Cleveringa|
|- CONTACT for SCIENTIFIC QUERIES||MD F.G.W. Cleveringa|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care|
(Source(s) of Monetary or Material Support)
|University Medical Center Utrecht (UMCU), Julius Center for Health Sciences and Primary Care |
|- Brief summary||The 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.
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.
Patients with type 2 diabetes mellitus treated by their primary care physician and able to visit the primary care practice.
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.
Change in cardiovascular risk (factors): HbA1c, blood pressure and cholesterol.
Changes in process of care, quality of life, and quality of care.
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)|
|- RECORD||20-feb-2007 - 1-dec-2009|