A Retrospective Analysis of the Adherence to Clinical Practice Guidelines Using the "MedicBK" Digital Platform in Patients With Hypertension and Atrial Fibrillation

Completed

• Conditions: Arterial Hypertension; Atrial Fibrillation
• Interventions: Drug: Retrospective analysis of assigned treatment

• Registration Number: NCT04564118
• Lead Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Brief Summary

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.

Detailed Description

There is a lot of data from registries about poor adherence to guidelines. It is connected with a problem that patients usually have a lot of comorbidities and physicians need to know сonsequently the huge number of medications and combinations. It is very difficult to decide quickly according to available data from libraries like PubMed. The Clinical Decision Support Systems (CDSS) based on real clinical data and its own Artificial Intelligence algorithms can help to make the right choice. This trial is designed to assess the difference between retrospective electronic medical cards (EMC) therapy prescriptions and MedicBK prescriptions based on key patient characteristics.

Two groups of experts (cardiologists with clinical practice for more than 5 years) will be participating in the trial.

Using main characteristics from EMC the first group of experts will put this data into MedicBK platform and assess retrospective treatment. The next blinded group of experts will perform prescriptions using MedicBK algorithms based on current guidelines and data from available clinical trials. The main hypothesis is the use Clinical Decision Support Systems (CDSS) better than current clinical practice. This option can help to make the right choice of medical combination based on main patient's clinical characteristics

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Primary Completion: 2020-11-01
• Status Verified: 2021-01
• Study Completion: 2021-01-11
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

1. Age > 18 years old
2. Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines.

Exclusion Criteria

1. Valvular cause of atrial fibrillation
2. GFR less than 30 ml / min
3. Active liver disease
4. Acute coronary syndrome
5. The presence of thyroid diseases as a cause of atrial fibrillation
6. Secondary arterial hypertension

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Retrospective analysis of assigned treatment	retrospective data on treatment from EMC

Primary Outcome Measures

Name	Time	Method
Assessment of AF/AH treatment guidelines compliance	1 MONTH	Number of electronic medical records not compliant to the AF/AH clinical practice guidelines

Secondary Outcome Measures

Name	Time	Method
Assessment of MedicBK programme	1 MONTH	Number of prescriptions from electronic medical records appropriate or inappropriate according to the AF/hypertension clinical practice guidelines in comparison with the treatment's choice of CDSS platform

Trial Locations

Locations (1)

V.A. Almazov Fnmrc; 🇷🇺 Saint-petersburg, Russian Federation