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

Samara Regional Cardiology Dispensary

Status: Completed

Conditions: Atrial Fibrillation; Arterial Hypertension

Treatments: Other: CDSS ("MedicBK")

Study type: Interventional

Funder types: Other

Identifiers

NCT05367141

SamaraRCD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 282 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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282 participants in 2 patient groups

CDSS

Active Comparator group

Description:

patient management with aid of CDSS

Treatment:

Other: CDSS ("MedicBK")

standart care

No Intervention group

Description:

patient management with standard care according to guidelines