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

Atrial Fibrillation Clinical Trial

— INTELLECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04564118
• Other study ID #: 909-2020
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: January 11, 2021

Study information

• Verified date: January 2021
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: January 11, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Hypertension
• Atrial Fibrillation
• Hypertension

Intervention

Drug:
• Retrospective analysis of assigned treatment
analysis of treatment assigned by physicians within routine clinical practice

Locations

Country	Name	City	State
Russian Federation	V.A. Almazov Fnmrc	Saint-petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health	Medicbook LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of AF/AH treatment guidelines compliance	Number of electronic medical records not compliant to the AF/AH clinical practice guidelines	1 MONTH
Secondary	Assessment of MedicBK programme	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	1 MONTH