Clinical trial NCT03188211: E-learning to Improve Oral Anticoagulant Use in Hospitalized Older People With AF
Official title: Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulation Training
Anticoagulant Drugs
Elderly
Atrial Fibrillation
Drug Prescriptions
Internal Medicine
Geriatrics
Lead sponsor: Mario Negri Institute for Pharmacological Research
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 247
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cluster randomized controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Elderly with AF prescribed with OAC
timeFrame: through study completion, up to 1 year
Secondary outcomes:
measure: Number of access to Dr Sim
timeFrame: 1 month
measure: Total duration of connection to Dr Sim
timeFrame: 1 month
measure: Elderly patients with AF prescribed with any antiplatelet agent
timeFrame: through study completion, up to 1 year
measure: Elderly patients with AF newly prescribed with OAC agents
timeFrame: through study completion, up to 1 year
measure: Patients experiencing any cerebro or cardiovascular events
timeFrame: 6 month follow up
measure: Re-hospitalization rate
timeFrame: 6 month follow up
measure: Minor bleeding events
timeFrame: 6 month follow up
measure: Major bleeding event
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
state: Bo
city: Brescia
country: Italy
facility: Istituto Fondazione Poliambulanza
state: BS
city: Catanzaro
country: Italy
facility: Policlinico Universitario Mater Domini
state: CZ
city: Modena
country: Italy
facility: AO Universitaria Policlinico di Modena
state: Italia
city: Monza
country: Italy
facility: Azienda Ospedaliera S. Gerardo di Monza
state: MB
city: Rivoli
country: Italy
facility: Ospedale degli Infermi
state: TO
city: Trieste
country: Italy
facility: Azienda Ospedaliera Universitaria - Ospedale Riuniti
state: TS
city: Varese
country: Italy
facility: A.O. Ospedale di Circolo e Fondazione Macchi
state: VA
city: Bari
country: Italy
facility: Azienda Consorziale Ospedaliera Policlinico
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
city: Genoa
country: Italy
facility: Azienda Ospedaliera Universitaria San Martino - IST
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone
city: Pavia
country: Italy
facility: Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo
city: Pavia
country: Italy
facility: Policlinico San Matteo
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratelli
city: Rome
country: Italy
facility: Policlinco Universitario Agostino Gemelli
city: Sassari
country: Italy
facility: Ospedale SS Annunziata
Study officials:
affiliation: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
name: Paola Santalucia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proietti M, Antoniazzi S, Monzani V, Santalucia P, Franchi C; SIM-AF Investigators; Fenoglio LM, Melchio R, Fabris F, Sartori MT, Manfredini R, De Giorgi A, Fabbian F, Biolo G, Zanetti M, Altamura N, Sabba C, Suppressa P, Bandiera F, Usai C, Murialdo G, Fezza F, Marra A, Castelli F, Cattaneo F, Beccati V, di Minno G, Tufano A, Contaldi P, Lupattelli G, Bianconi V, Cappellini D, Hu C, Minonzio F, Fargion S, Burdick L, Francione P, Peyvandi F, Rossio R, Colombo G, Monzani V, Ceriani G, Lucchi T, Brignolo B, Manfellotto D, Caridi I, Corazza GR, Miceli E, Padula D, Fraternale G, Guasti L, Squizzato A, Maresca A, Liberato NL, Tognin T, Rozzini R, Bellucci FB, Muscaritoli M, Molfino A, Petrillo E, Dore M, Mete F, Gino M, Franceschi F, Gabrielli M, Perticone F, Perticone M, Bertolotti M, Mussi C, Borghi C, Strocchi E, Durazzo M, Fornengo P, Dallegri F, Ottonello LC, Salam K, Caserza L, Barbagallo M, Di Bella G, Annoni G, Bruni AA, Odetti P, Nencioni A, Monacelli F, Napolitano A, Brucato A, Valenti A, Castellino P, Zanoli L, Mazzeo M. Use of oral anticoagulant drugs in older patients with atrial fibrillation in internal medicine wards. Eur J Intern Med. 2018 Jun;52:e12-e14. doi: 10.1016/j.ejim.2018.04.006. Epub 2018 Apr 12. No abstract available.
citation: Antoniazzi S, Ardoino I, Proietti M, Monzani V, Mannucci PM, Nobili A, Franchi C; SIM-AF Collaborators. Appropriateness of prescription of oral anticoagulant therapy in acutely hospitalized older people with atrial fibrillation. Secondary analysis of the SIM-AF cluster randomized clinical trial. Br J Clin Pharmacol. 2019 Sep;85(9):2134-2142. doi: 10.1111/bcp.14029. Epub 2019 Jul 19.
citation: Franchi C, Antoniazzi S, Ardoino I, Proietti M, Marcucci M, Santalucia P, Monzani V, Mannucci PM, Nobili A; SIM-AF Collaborators. Simulation-Based Education for Physicians to Increase Oral Anticoagulants in Hospitalized Elderly Patients with Atrial Fibrillation. Am J Med. 2019 Aug;132(8):e634-e647. doi: 10.1016/j.amjmed.2019.03.052. Epub 2019 May 8.