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

NCT03188211 | Completed DMC

• 1 other identifier: BMS ISR # CV185-483
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 20

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of access to Dr Sim

  1 month

• Total duration of connection to Dr Sim

  1 month

• Elderly patients with AF prescribed with any antiplatelet agent

  through study completion, up to 1 year

• Elderly patients with AF newly prescribed with OAC agents

  through study completion, up to 1 year

• Patients experiencing any cerebro or cardiovascular events

  6 month follow up

Study Arms (2)

Intervention

OTHER

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

Control

OTHER

Clinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim).

Other: Control

Interventions

E-learning educational program OTHER

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.

Also known as: Dr Sim

Intervention

Control OTHER

Any educational program will be delivered to clinicians assigned to control arm

Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (20)

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

Bologna, Bo, 40138, Italy

Location

Istituto Fondazione Poliambulanza

Brescia, BS, 25100, Italy

Location

Policlinico Universitario Mater Domini

Catanzaro, CZ, 88100, Italy

Location

AO Universitaria Policlinico di Modena

Modena, Italia, 41124, Italy

Location

Azienda Ospedaliera S. Gerardo di Monza

Monza, MB, 20900, Italy

Location

Ospedale degli Infermi

Rivoli, TO, 10098, Italy

Location

Azienda Ospedaliera Universitaria - Ospedale Riuniti

Trieste, TS, 34121, Italy

Location

A.O. Ospedale di Circolo e Fondazione Macchi

Varese, VA, 21100, Italy

Location

Azienda Consorziale Ospedaliera Policlinico

Bari, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, 24127, Italy

Location

Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"

Catania, Italy

Location

Azienda Ospedaliera Universitaria San Martino - IST

Genoa, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Azienda Ospedaliera di Padova

Padua, 35128, Italy

Location

Azienda Ospedaliera Universitaria Policlinico P. Giaccone

Palermo, Italy

Location

Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo

Pavia, Italy

Location

Policlinico San Matteo

Pavia, Italy

Location

Ospedale San Giovanni Calibita Fatebenefratelli

Roma, Italy

Location

Policlinco Universitario Agostino Gemelli

Rome, Italy

Location

Ospedale SS Annunziata

Sassari, Italy

Location

Related Publications (3)

• 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.

  PMID: 29657108 RESULT

• 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.

  PMID: 31218738 DERIVED

• 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.

  PMID: 31075225 DERIVED

Related Links

• Letters to Editor

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paola Santalucia, MD

  Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: cluster randomized controlled trial

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 15, 2017
• Study Start: September 1, 2017
• Primary Completion: January 22, 2018
• Study Completion: September 30, 2018
• Last Updated: November 13, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (20)