E-learning to Improve Oral Anticoagulant Use in Hospitalized Older People With AF

Study Overview
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Brief Summary
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Atrial Fibrillation (AF) is the most common cardiac arrhythmia and the main cause of cardioembolic stroke. Oral Anticoagulation (OAC) has been shown to significantly prevent AF-related thromboembolism, however, despite convincing evidences and current guidelines recommendations, OAC tends to be underused in clinical practice especially in the oldest. Education and training to appropriately select people suitable for OAC for stroke prevention could be pivotal in the decision making process. According to the study project, physicians working in Internal Medicine and Geriatric wards, where are mainly admitted elderly people with AF, will undergo to a program of e-learning through computer-based simulation method reproducing clinical scenarios of patients aged 65 years or older, with known or newly diagnosed AF, admitted to hospital for any medical reason and requesting that a decision about long-term antithrombotic therapy is taken. Primary objective of the study is to investigate whether such educational intervention will improve the appropriate use and prescription rate of OAC in hospitalised elderly patients with AF, multimorbidity and polypharmacy, in comparison to the usual practice. The study will be a cluster randomised controlled trial involving a network of Internal Medicine and Geriatrics wards. Thirty-two wards will be recruited based on voluntary participation and randomised to receive an educational intervention through computer-based simulation, (N=16) or to continue with the usual practice (N=16). Subjects receiving the intervention will be all the staff physicians of the wards randomised in the intervention arm. The impact of the intervention compared with the usual practice will be evaluated in patients aged 65 years or older admitted to the participating centres with a known diagnosis of AF or newly diagnosed with AF during the hospitalisation.

Official Title
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Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation

Conditions
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Simulation Training, Anticoagulant Drugs, Atrial Fibrillation, Drug Prescriptions, Internal Medicine, Geriatrics, Elderly

Intervention / Treatment
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* Other: E-learning educational program
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects 65 years of age or older, with known or newly diagnosed AF, admitted to the Internal Medicine and Geriatric wards of the REPOSI network, consent to participate to the study. Exclusion Criteria: consent denial to participate to the study, absolute contraindication to OAC, re-hospitalisation for the subject already included in the study, life expectancy less than 6 months.

Ages Eligible for Study
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Minimum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: cluster randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention<br>Clinicians allocated to intervention arm will receive an e-learning educational program based on simulation-based technologies (Dr Sim). Dr Sim provides a powerful editing system that allows to create clinical cases according to the educational need and purposes. It will be distributed on an e-learning platform, allowing the user to act in a highly interactive learning environment. Management of the virtual patients is carried out interactively and each diagnostic and or therapeutic choice will be supported by any scientific data, guidelines recommendations, drug descriptions and literature references useful to address the best choice for that specific patient as it should be in real practice. | Other: E-learning educational program<br>* A number of 10 cases of patients 65 years of age or older with AF, acutely admitted to Internal Medicine or Geriatric wards for any medical condition, will be edited into the Dr. Sim system. Diagnostic and therapeutic choices for ordinary and/or complex medical situations will be taken through the development of the simulated scenario.<br>* Other names: Dr Sim;|
| Other: Control<br>Clinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim). | Other: Control<br>* Any educational program will be delivered to clinicians assigned to control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elderly with AF prescribed with OAC | difference in the proportion of elderly patients with AF prescribed with OAC between the post-intervention and the pre-intervention observational phase | through study completion, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of access to Dr Sim | average number of access to Dr. Sim among the phsyicians of the centres randomised to the intervention during the 1 month intervention phase | 1 month | 
| Total duration of connection to Dr Sim | average total duration of connection to Dr. Sim among the phsyicians of the centres randomised to the intervention during the 1 month intervention phase | 1 month | 
| Elderly patients with AF prescribed with any antiplatelet agent | difference in the proportion of elderly patients with AF prescribed with any antiplatelet agent (and not OAC) between the post-intervention and the pre-intervention observational phase | through study completion, up to 1 year | 
| Elderly patients with AF newly prescribed with OAC agents | difference in the proportion of elderly patients with AF prescribed with new OAC agents between the post-intervention and the pre-intervention observational phase | through study completion, up to 1 year | 
| Patients experiencing any cerebro or cardiovascular events | proportion of patients experiencing any stroke, transient ischaemic attack (TIA), other major arterial or venous thromboembolism during the 6 months after the hospital discharge | 6 month follow up | 
| Re-hospitalization rate | proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge | 6 month follow up | 
| Minor bleeding events | proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge) | 6 month follow up | 
| Major bleeding event | proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge) | 6 month follow up |