Guideline Adherence in Dyslipidemia With Clinical Decision Support

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Absence of a consensus opinion on the clinical case among two of the three experts.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: General cohort

Trial outcomes

Primary outcomes

1

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

Time frame
At the end of the study: on average, 1.5 years
2

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

Time frame
At the end of the study: on average, 1.5 years
3

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

Time frame
At the end of the study: on average, 1.5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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