Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation
| Registry | NCT03188211, acronym SIM-AF |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 247 (Actual) |
| Sponsor | Mario Negri Institute for Pharmacological Research (Other) |
| Conditions | Simulation Training, Anticoagulant Drugs, Elderly, Atrial Fibrillation, Drug Prescriptions, Internal Medicine, Geriatrics |
| Interventions | E-learning educational program, Control (Other) |
| Dates | start 2017-09-01, primary completion 2018-01-22, completion 2018-09-30, first posted 2017-06-15, last updated 2018-11-13 |
| Locations | 20 sites in Italy |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Simulation Training All trials for Anticoagulant Drugs All trials of E-learning educational program All trials of Control
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention | Other | Other: E-learning educational program | 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. |
| Control | Other | Other: Control | Clinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim). |
Sex: All, ages: 65 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 | |
| Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele" | Catania | Italy | |
| Azienda Ospedaliera Universitaria San Martino - IST | Genoa | Italy | |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan | Italy | |
| Azienda Ospedaliera di Padova | Padova | Italy | |
| Azienda Ospedaliera Universitaria Policlinico P. Giaccone | Palermo | Italy | |
| Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo | Pavia | Italy | |
| Policlinico San Matteo | Pavia | Italy | |
| Ospedale San Giovanni Calibita Fatebenefratelli | Roma | Italy | |
| Policlinco Universitario Agostino Gemelli | Rome | Italy | |
| Ospedale SS Annunziata | Sassari | Italy |