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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Atrial Fibrillation, Arterial Hypertension

Intervention / Treatment
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* Other: CDSS (MedicBK)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CDSS<br>patient management with aid of CDSS | Other: CDSS (MedicBK)<br>* 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.<br>|
| No Intervention: standart care<br>patient management with standard care according to guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with AF/hypertension clinical practice guidelines | 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 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cardiovascular events | 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 | 6 months | 
| Total mortality | death from all causes | 6 months | 
| total number of non-planing visits and hospitalization | non-planing hospitalizations, non-planning visits, urgent visits | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine