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

Sponsor

Samara Regional Cardiology Dispensary (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05367141

Collaborator

Medicbook LLC (Other)

436

Enrollment

Arms

3.8

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Arterial Hypertension	Other: CDSS ("MedicBK")	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

436 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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)

Anticipated Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Aug 24, 2022

Anticipated Study Completion Date :

Sep 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CDSS patient management with aid of CDSS	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.
No Intervention: standart care patient management with standard care according to guidelines

Arm

Intervention/Treatment

Active Comparator: CDSS

patient management with aid of CDSS

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.

No Intervention: standart care

patient management with standard care according to guidelines

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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