SIM-AF: E-learning to Improve Oral Anticoagulant Use in Hospitalized Older People With AF
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Intervention 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
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.
Other Names:
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| Other: Control Clinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim). |
Other: Control
Any educational program will be delivered to clinicians assigned to control arm
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Outcome Measures
Primary Outcome Measures
- Elderly with AF prescribed with OAC [through study completion, up to 1 year]
difference in the proportion of elderly patients with AF prescribed with OAC between the post-intervention and the pre-intervention observational phase
Secondary Outcome Measures
- Number of access to Dr Sim [1 month]
average number of access to Dr. Sim among the phsyicians of the centres randomised to the intervention during the 1 month intervention phase
- Total duration of connection to Dr Sim [1 month]
average total duration of connection to Dr. Sim among the phsyicians of the centres randomised to the intervention during the 1 month intervention phase
- Elderly patients with AF prescribed with any antiplatelet agent [through study completion, up to 1 year]
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
- Elderly patients with AF newly prescribed with OAC agents [through study completion, up to 1 year]
difference in the proportion of elderly patients with AF prescribed with new OAC agents between the post-intervention and the pre-intervention observational phase
- Patients experiencing any cerebro or cardiovascular events [6 month follow up]
proportion of patients experiencing any stroke, transient ischaemic attack (TIA), other major arterial or venous thromboembolism during the 6 months after the hospital discharge
- Re-hospitalization rate [6 month follow up]
proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge
- Minor bleeding events [6 month follow up]
proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)
- Major bleeding event [6 month follow up]
proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)
Eligibility Criteria
Criteria
Inclusion Criteria:
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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,
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consent to participate to the study.
Exclusion Criteria:
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consent denial to participate to the study,
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absolute contraindication to OAC,
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re-hospitalisation for the subject already included in the study,
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life expectancy less than 6 months.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi | Bologna | Bo | Italy | 40138 |
| 2 | Istituto Fondazione Poliambulanza | Brescia | BS | Italy | 25100 |
| 3 | Policlinico Universitario Mater Domini | Catanzaro | CZ | Italy | 88100 |
| 4 | AO Universitaria Policlinico di Modena | Modena | Italia | Italy | 41124 |
| 5 | Azienda Ospedaliera S. Gerardo di Monza | Monza | MB | Italy | 20900 |
| 6 | Ospedale degli Infermi | Rivoli | TO | Italy | 10098 |
| 7 | Azienda Ospedaliera Universitaria - Ospedale Riuniti | Trieste | TS | Italy | 34121 |
| 8 | A.O. Ospedale di Circolo e Fondazione Macchi | Varese | VA | Italy | 21100 |
| 9 | Azienda Consorziale Ospedaliera Policlinico | Bari | Italy | ||
| 10 | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | Italy | 24127 | |
| 11 | Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" | Catania | Italy | ||
| 12 | Azienda Ospedaliera Universitaria San Martino - IST | Genoa | Italy | ||
| 13 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | ||
| 14 | Azienda Ospedaliera di Padova | Padova | Italy | 35128 | |
| 15 | Azienda Ospedaliera Universitaria Policlinico P. Giaccone | Palermo | Italy | ||
| 16 | Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo | Pavia | Italy | ||
| 17 | Policlinico San Matteo | Pavia | Italy | ||
| 18 | Ospedale San Giovanni Calibita Fatebenefratelli | Roma | Italy | ||
| 19 | Policlinco Universitario Agostino Gemelli | Rome | Italy | ||
| 20 | Ospedale SS Annunziata | Sassari | Italy |
Sponsors and Collaborators
- Mario Negri Institute for Pharmacological Research
Investigators
- Principal Investigator: Paola Santalucia, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- BMS ISR # CV185-483