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

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)

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arterial Hypertension
• Intervention / Treatment: Drug: Retrospective analysis of assigned treatment

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 Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-petersburg, Russian Federation, 197341
    • V.A. Almazov Fnmrc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with nonvalvular atrial fibrillation and essential hypertension having indications for therapy according to European guidelines

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; retrospective data on treatment from EMC	Drug: Retrospective analysis of assigned treatment; analysis of treatment assigned by physicians within routine clinical practice
Group 2; Treatment assignment using medicBC CDSS platform in the same cohort of patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of AF/AH treatment guidelines compliance	Number of electronic medical records not compliant to the AF/AH clinical practice guidelines	1 MONTH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): January 11, 2021

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: atrial fibrillation; arterial hypertension; Clinical Decision Support System; digital medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arrhythmias, Cardiac; Hypertension; Atrial Fibrillation
• Other Study ID Numbers: 909-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No