NCT05367141

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

Active (CDSS) Control Blinded Multicenter, Cluster-randomized Trial of the Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation (INTELLECT II Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (actual)
• Sponsor: Samara Regional Cardiology Dispensary · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Arterial Hypertension

Interventions

Type	Name	Description
OTHER	CDSS ("MedicBK")	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.

Timeline

• Start date: 2022-05-17
• Primary completion: 2022-12-24
• Completion: 2023-08-22
• First posted: 2022-05-10
• Last updated: 2026-02-02

Locations

1 site across 1 country: Russia