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

NCT ID: NCT03188211

Last Updated: 2018-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 247 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

E-learning educational program

Intervention Type: 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.

Control

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

Group Type: OTHER

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Other Intervention Names

Dr Sim

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Santalucia, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Locations

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

Padua, , 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

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 29657108 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31218738 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31075225 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/29657108

Letters to Editor

Other Identifiers

BMS ISR # CV185-483

Identifier Type: -

Identifier Source: org_study_id