Guideline Adherence in Dyslipidemia With Clinical Decision Support

February 22, 2026 updated by: I.M. Sechenov First Moscow State Medical University

Assessment of Adherence to Clinical Practice Guidelines in Patients With Dyslipidemia Using a Clinical Decision Support System

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study was conducted as a retrospective observational study and was aimed at developing and applying a decision support system for physicians treating patients with lipid metabolism disorders based on a decision tree algorithm as well as to assess the degree of compliance with clinical guidelines for the management of patients with dyslipidemia in real clinical practice.

As part of the study, a retrospective analysis of the electronic medical records of adult participants will be conducted. Clinical data will be extracted from medical records, including demographic characteristics, laboratory lipid profile indicators (total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides), kidney function indicators (creatinine level and estimated glomerular filtration rate), biochemical parameters, including alanine aminotransferase and creatine phosphokinase levels, as well as information on concomitant and past diseases.

The data of 500 participants 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.

The lipid-lowering therapy prescriptions actually administered by treating physicians and recorded in medical records will be compared with the recommendations generated by the clinical decision support system. An independent expert assessment will be conducted. An expert group consisting of three physicians will form their own recommendations for therapy based on each patients' clinical data, without having access to information about the actual prescriptions and the results of the algorithm, which ensured a blinded assessment of the endpoints.

Immediately after all patients have completed the questionnaire, two independent expert opinions will also be obtained for each patient. Then, by comparing the decisions of the attending physicians, the recommendations of the clinical decision support system, and the conclusions of the expert group, the degree of compliance of actual clinical practice with current clinical guidelines for the management of patients with dyslipidemia will be assessed.

The patient's personal data (surname, first name, patronymic, date of birth, contact details) will not be transferred. Each patient is assigned an individual number that is not linked to their personal data.

A web interface was developed based on a decision tree compiled from several current guidelines. A questionnaire was created for entering anonymized patient data. The system's output is a cardiovascular risk assessment or recommendations for lipid-lowering therapy.

Following clinical guidelines were used:

  • Clinical Practice Guidelines - Lipid Metabolism Disorders. Approved by the Ministry of Health of the Russian Federation, 2023.
  • ESC/EAS Guidelines for the Treatment of Dyslipidemias: Lipid Modification for Reducing Cardiovascular Risk, 2019.
  • ESC/EOAS Guidelines for the Treatment of Patients with Arterial Hypertension, 2018.
  • Arterial Hypertension in Adults. Approved by the Ministry of Health of the Russian Federation, 2024.
  • Stable Ischemic Heart Disease. Approved by the Ministry of Health of the Russian Federation, 2024.
  • ESC Guidelines for the Diagnosis and Treatment of Chronic Coronary Syndrome, 2019.
  • ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure, 2021.
  • Chronic Heart Failure. Approved by the Ministry of Health of the Russian Federation, 2024.
  • Chronic Kidney Disease (CKD). Approved by the Ministry of Health of the Russian Federation, 2024.
  • Clinical guidelines for non-alcoholic fatty liver disease. Approved by the Ministry of Health of the Russian Federation, 2023.

A statistical analysis will be conducted on the prevalence and nature of medical errors in the EXСEL system (descriptive statistics). No comparative analysis will be conducted. The parameters of the accuracy of the CDSS will be determined using a four-field table method.

The reference in this study is the decision of two of the three or all three experts on the correctness of the cardiovascular risk assessment, the correctness of the prescription of drug therapy, the correctness of the recommended diet and physical exercise, the correctness of patient monitoring (repeated blood tests, timely completion of examinations).

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russia
      • Moscow, Russia, 119435
        • 1 University Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  1. Availability of the required amount of patient data for completion of the questionnaire-based system;
  2. Age 18 years or older;
  3. Signed informed consent to participate in the study.

Non-inclusion criteria:

  1. Patients with insufficient data to complete the questionnaire;

  2. Refusal to sign informed consent for participation in the study.

    Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medical error in the interpretation of cardiovascular risk
Time Frame: At the end of the study: on average, 1.5 years
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
Time Frame: At the end of the study: on average, 1.5 years
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
Time Frame: At the end of the study: on average, 1.5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

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

  • 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

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 9, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 22, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChPSH22262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is not possible to provide documentation due to the prohibition received from the local ethics committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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