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

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Elderly; Geriatrics; Simulation Training; Anticoagulant Drugs; Internal Medicine; Drug Prescriptions
• Intervention / Treatment: Other: E-learning educational program; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy
    • Azienda Consorziale Ospedaliera Policlinico
  • Bergamo, Italy, 24127
    • Azienda Ospedaliera Papa Giovanni XXIII
  • Catania, Italy
    • Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
  • Genoa, Italy
    • Azienda Ospedaliera Universitaria San Martino - IST
  • Milano, Italy
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Palermo, Italy
    • Azienda Ospedaliera Universitaria Policlinico P. Giaccone
  • Pavia, Italy
    • Policlinico San Matteo
  • Pavia, Italy
    • Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo
  • Roma, Italy
    • Ospedale San Giovanni Calibita Fatebenefratelli
  • Rome, Italy
    • Policlinco Universitario Agostino Gemelli
  • Sassari, Italy
    • Ospedale SS Annunziata
  • BS
    • Brescia, BS, Italy, 25100
      • Istituto Fondazione Poliambulanza
  • Bo
    • Bologna, Bo, Italy, 40138
      • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
  • CZ
    • Catanzaro, CZ, Italy, 88100
      • Policlinico Universitario Mater Domini
  • Italia
    • Modena, Italia, Italy, 41124
      • AO Universitaria Policlinico di Modena
  • MB
    • Monza, MB, Italy, 20900
      • Azienda Ospedaliera S. Gerardo di Monza
  • TO
    • Rivoli, TO, Italy, 10098
      • Ospedale degli Infermi
  • TS
    • Trieste, TS, Italy, 34121
      • Azienda Ospedaliera Universitaria - Ospedale Riuniti
  • VA
    • Varese, VA, Italy, 21100
      • A.O. Ospedale di Circolo e Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Dr Sim
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Investigators: Principal Investigator: Paola Santalucia, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Letters to Editor

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): January 22, 2018
• Study Completion (ACTUAL): September 30, 2018

Study Registration Dates

• First Submitted: June 5, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (ACTUAL): June 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: BMS ISR # CV185-483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No