- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00348751
CholGate - The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners
May 7, 2008 updated by: Erasmus Medical Center
The Effect of Alerting Versus on Demand Computer Based Decision Support on Treatment of Dyslipidaemia by General Practitioners - The CholGate Randomized Trial
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system.
However, randomized trials comparing these methods in a clinical setting are lacking.
In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Indirect evidence show alerting physicians with clinical decision support systems (CDSS) seem to change behaviour more than requiring users to actively initiate the system.
However, randomized trials comparing these methods in a clinical setting are lacking.
In this study we compare the effect of Alerting physicians with a CDSS or actively requiring initiation of CDSS on the adherence of Dutch general practitioners to the Cholesterol guideline of the Dutch college of General Practitioners, using a clinical decsion support system called CholGate.
This system has the functionality to provide both Alerting and On-Demand decision support.
Users are free to negate the advise provided by the decision support system.
The trial will have a cluster randomized structure.
Study Type
Interventional
Phase
- Not Applicable
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
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South Holland
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Rotterdam, South Holland, Netherlands, 3000DR
- Department of Medical informatics, ErasmusMC
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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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All general practices using only Elias electronic patient records (ISOFT b.V)
- All patients meeting the screening and treatment criteria of the Dutch college of general practitioners cholesterol guideline
Exclusion Criteria:
- Practices that used paper based records
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The percentage of correctly screened patients using anonymous patient record data.
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The percentage of correctly treated patients using anonymous patient record data.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacobus T van Wyk, MD, PhD, ErasmusMC University Medical Centre Rotterdam
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.
General Publications
- van Wyk JT, Picelli G, Dieleman JP, Mozaffari E, Kramarz P, van Wijk MA, van der Lei J, Sturkenboom MC. Management of hypertension and hypercholesterolaemia in primary care in The Netherlands. Curr Med Res Opin. 2005 Jun;21(6):839-48. doi: 10.1185/030079905X46368.
- Van Wyk JT, Van Wijk MA, Moorman PW, Mosseveld M, Van Der Lei J. Cholgate - a randomized controlled trial comparing the effect of automated and on-demand decision support on the management of cardiovascular disease factors in primary care. AMIA Annu Symp Proc. 2003;2003:1040.
- Van Wyk JT, Van Wijk MA. Assessment of the possibility to classify patients according to cholesterol guideline screening criteria using routinely recorded electronic patient record data. Stud Health Technol Inform. 2002;93:39-46.
- Van Wyk JT, Van Wijk MA. Analysis of Dutch general practice guidelines for inconsistencies with respect to the management of cardiovascular disease risk factors. Stud Health Technol Inform. 2004;107(Pt 1):179-86.
- Dieleman JP, van Wyk JT, van Wijk MA, van Herpen G, Straus SM, Dunselman H, Sturkenboom MC. Differences between statins on clinical endpoints: a population-based cohort study. Curr Med Res Opin. 2005 Sep;21(9):1461-8. doi: 10.1185/030079905X61866.
- van Wyk JT, van Wijk MA, Sturkenboom MC, Moorman PW, van der Lei J. Identification of the four conventional cardiovascular disease risk factors by Dutch general practitioners. Chest. 2005 Oct;128(4):2521-7. doi: 10.1378/chest.128.4.2521.
- van Wyk JT, van Wijk MA, Moorman PW, van der Lei J. Cross-sectional analysis of guidelines on cardiovascular disease risk factors: going to meet the inconsistencies. Med Decis Making. 2006 Jan-Feb;26(1):57-62. doi: 10.1177/0272989X05284104.
- van Wyk JT, van Wijk MA, Moorman PW, Mosseveld M, van der Lei J. User requirements rating and knowledge-level of general practitioners at the start of CholGate - a lipid management decision support project. AMIA Annu Symp Proc. 2005;2005:1146.
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
June 1, 2004
Study Completion
November 1, 2005
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
July 5, 2006
First Posted (Estimate)
July 6, 2006
Study Record Updates
Last Update Posted (Estimate)
May 8, 2008
Last Update Submitted That Met QC Criteria
May 7, 2008
Last Verified
June 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000B161
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.
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