Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation

Study Overview
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Brief Summary
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To determine whether a comprehensive evaluation and customized multilevel educational interventions will increase the rate of use of oral anticoagulants and the adherence and persistence of use in patients with atrial fibrillation. Our hypothesis is that there will be differences in the use of oral anticoagulants and the persistence in patients between the control and interventional group. There will be a greater change in the use of oral anticoagulants over one year in the cohort in the intervention sites than the control sites. This will be due to two factors: greater initiation of oral anticoagulants among patients not treated at baseline and greater persistence of treatment for those on treatment at baseline

Official Title
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An International Multicenter Clustered Randomized Controlled Trial to imProve Treatment With AntiCoagulanTs in Patients With Atrial Fibrillation.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Educational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Patients over the age of 18 with paroxysmal, persistent or permanent atrial fibrillation who have a 12-lead ECG showing atrial fibrillation and/or more than one rhythm strip showing atrial fibrillation at least 2 weeks apart, not due to a reversible cause (like post-CABG)) 2. At least one of the traditional CHADS2 risk factors or at least two CHA2DS2 VASc risk factors Exclusion Criteria: Mechanical prosthetic valve Clinically unstable at the time of enrollment (ie, with ongoing shock) Terminal illness and/or comfort care Unable to provide consent (e.g. severe cognitive impairment) Patients unable to have one year of follow-up for any reason Clear and absolute contraindication to oral anticoagulation (for example, active bleeding or recent life-threatening bleeding such as ICH)

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>educational intervention arm | Other: Educational Intervention<br>* This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country<br>|
| No Intervention: control<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of patients taking oral anticoagulants | Change in proportion of patients taking oral anticoagulants from baseline to one year | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in proportion of patients able to continue anticoagulation | Change in proportion of patients able to continue anticoagulation for one year | 1 year | 
| Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation | Change in proportion of patients who are not on anticoagulation at baseline and are on anticoagulation at one year | 1 year | 
| Death, total |  | 1 year | 
| Stroke, hemorrhagic and non-hemorrhagic |  | 1 year | 
| Major and non-major clinically relevant bleeding |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, anticoagulation, education, educational intervention