Guideline Adherence in Dyslipidemia With Clinical Decision Support
Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System
1 other identifier
observational
500
1 country
1
Brief Summary
Objective: To validate the performance of the developed clinical decision support system (CDSS) for participants with lipid metabolism disorders based on a decision tree algorithm. Materials and Methods: A clinical decision support system for participants with lipid profile abnormalities will be developed using the Orbeon open-source online form creation platform based on current clinical guidelines. During the CDSS pilot implementation, the electronic medical records (EMRs) of 500 participants from the Institute of Personalized Cardiology of the Biomedical Science and Technology Park at Sechenov University will be analyzed. Retrospective data on prescribed lipid-lowering therapy extracted from the EHR will be compared with the CDSS recommendations. The accuracy of the decisions will be assessed by three independent experts based on digitized clinical and laboratory patient profiles. The primary endpoint of the study will be to determine the accuracy of the system. Results: This study will result in the development (creation) and pilot application of the CDSS program in participants with dyslipidemia in real clinical practice. Conclusion: The developed CDSS system for dyslipidemia will significantly reduce the time required for clinical decision-making and help avoid errors in the interpretation of patient data.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
February 24, 2026
February 1, 2026
1.1 years
February 9, 2026
February 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Medical error in the interpretation of cardiovascular risk
The number and type of incorrect interpretation of a patient's cardiovascular risk by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
At the end of the study: on average, 1.5 years
Medical error in prescribing lipid-lowering therapy
The number and type of incorrect prescribing lipid-lowering by a physician will be determined by three independent experts in comparison with the results of the medical decision support system
At the end of the study: on average, 1.5 years
Errors frequency in the functioning of the developed medical decision support system compared to the decision of three independent experts
Errors frequency in the functioning of the developed medical decision support system will be determined when compared to the decision of three independent experts
At the end of the study: on average, 1.5 years
Study Arms (1)
General cohort
500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines
Eligibility Criteria
The data of 500 patients will be structured and entered into an electronic form, which serves as the basis for a clinical decision support system implemented in the form of a decision tree algorithm. This system will be used exclusively for analytical purposes and make it possible to determine the indications for prescribing lipid-lowering therapy, its recommended intensity, and the need to adjust drug doses in accordance with current clinical guidelines.
You may qualify if:
- Availability of the required amount of patient data for completion of the questionnaire-based system;
- Age 18 years or older;
- Signed informed consent to participate in the study.
- Patients with insufficient data to complete the questionnaire;
- Refusal to sign informed consent for participation in the study.
You may not qualify if:
- Absence of a consensus opinion on the clinical case among two of the three experts.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1 University Hospital
Moscow, 119435, Russia
Related Publications (1)
Evaluation of the effectiveness of lipid-lowering therapy in real clinical practice / N. O. Kuznetsova, F. E. Mamedzade, M. A. Podyanov [et al.] // Doctor.Ru. - 2024. - Vol. 23, No. 8. - Pp. 41-46. - DOI 10.31550/1727-2378-2024-23-8-41-46. - EDN ANFDYI
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2026
First Posted
February 17, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
It is not possible to provide documentation due to the prohibition received from the local ethics committee