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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
247
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.
Any educational program will be delivered to clinicians assigned to control arm
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Bo, Italy
Istituto Fondazione Poliambulanza
Brescia, BS, Italy
Policlinico Universitario Mater Domini
Catanzaro, CZ, Italy
AO Universitaria Policlinico di Modena
Modena, Italia, Italy
Azienda Ospedaliera S. Gerardo di Monza
Monza, MB, Italy
Ospedale degli Infermi
Rivoli, TO, Italy
Azienda Ospedaliera Universitaria - Ospedale Riuniti
Trieste, TS, Italy
A.O. Ospedale di Circolo e Fondazione Macchi
Varese, VA, Italy
Azienda Consorziale Ospedaliera Policlinico
Bari, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
...and 10 more locations
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
Time frame: through study completion, up to 1 year
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 month follow up
Re-hospitalization rate
proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge
Time frame: 6 month follow up
Minor bleeding events
proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)
Time frame: 6 month follow up
Major bleeding event
proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)
Time frame: 6 month follow up
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