Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Arterial Hypertension
• Interventions: Other: CDSS ("MedicBK")

• Registration Number: NCT05367141
• Lead Sponsor: Samara Regional Cardiology Dispensary

Brief Summary

The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).

Detailed Description

Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.

Study Timeline

• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-10
• Study Start: 2022-05-17
• Primary Completion: 2022-12-24
• Study Completion: 2023-08-22
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

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

Exclusion Criteria

• Inability to adhere to study procedures
• Severe heart-valve disorder
• Stroke within 14 days or severe stroke within 6 months before screening
• Active bleedings
• Thyroid dysfunction
• Pregnancy
• Secondary hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDSS	CDSS ("MedicBK")	patient management with aid of CDSS

Primary Outcome Measures

Name	Time	Method
Compliance with AF/hypertension clinical practice guidelines	1 month	number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK

Secondary Outcome Measures

Name	Time	Method
Total cardiovascular events	6 months	total stroke or systemic embolism, total coronary heart disease, major bleeding, recurrence of atrial fibrillation, hospitalization or death from congestive heart failure and other significant vascular deaths
Total mortality	6 months	death from all causes
total number of non-planing visits and hospitalization	6 months	non-planing hospitalizations, non-planning visits, urgent visits

Trial Locations

Locations (1)

Samara Regional Cardiology Dispansery; 🇷🇺 Samara, Russian Federation