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

Atrial Fibrillation Clinical Trial

— SIM-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03188211
• Other study ID #: BMS ISR # CV185-483
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: November 2018
• Source: Mario Negri Institute for Pharmacological Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: September 30, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• Control
Any educational program will be delivered to clinicians assigned to control arm

Locations

Country	Name	City	State
Italy	Azienda Consorziale Ospedaliera Policlinico	Bari
Italy	Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi	Bologna	Bo
Italy	Istituto Fondazione Poliambulanza	Brescia	BS
Italy	Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"	Catania
Italy	Policlinico Universitario Mater Domini	Catanzaro	CZ
Italy	Azienda Ospedaliera Universitaria San Martino - IST	Genoa
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	AO Universitaria Policlinico di Modena	Modena	Italia
Italy	Azienda Ospedaliera S. Gerardo di Monza	Monza	MB
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 degli Infermi	Rivoli	TO
Italy	Ospedale San Giovanni Calibita Fatebenefratelli	Roma
Italy	Policlinco Universitario Agostino Gemelli	Rome
Italy	Ospedale SS Annunziata	Sassari
Italy	Azienda Ospedaliera Universitaria - Ospedale Riuniti	Trieste	TS
Italy	A.O. Ospedale di Circolo e Fondazione Macchi	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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, Sabbà C, Suppressa P, Bandiera F, Usai C, Murialdo G, F — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Re-hospitalization rate	proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge	6 month follow up
Secondary	Minor bleeding events	proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)	6 month follow up
Secondary	Major bleeding event	proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)	6 month follow up

External Links

•   Letters to Editor