Simulation TrainingSIM-AFNCT03188211
E-learning to Improve Oral Anticoagulant Use in Hospitalized Older People With AF
A study testing E-learning educational program in people with Simulation Training and Anticoagulant Drugs, run by Mario Negri Institute for Pharmacological Research at 20 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Simulation Training, Anticoagulant Drugs, Elderly
- What is being tested?
- E-learning educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 20 sitesItaly
- Study dates
- 1 Sep 2017to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Italy20 sites
Azienda Consorziale Ospedaliera Policlinico
Bari
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi
Bologna, Bo, 40138
Istituto Fondazione Poliambulanza
Brescia, BS, 25100
Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
Catania
Policlinico Universitario Mater Domini
Catanzaro, CZ, 88100
Azienda Ospedaliera Universitaria San Martino - IST
Genoa
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
AO Universitaria Policlinico di Modena
Modena, Italia, 41124
Azienda Ospedaliera S. Gerardo di Monza
Monza, MB, 20900
Azienda Ospedaliera di Padova
Padova, 35128
Azienda Ospedaliera Universitaria Policlinico P. Giaccone
Palermo
Azienda SocioSanitaria Territoriale, Ospedale Civile "C.Mira" di Casorate Primo
Pavia
Policlinico San Matteo
Pavia
Ospedale degli Infermi
Rivoli, TO, 10098
Ospedale San Giovanni Calibita Fatebenefratelli
Roma
Policlinco Universitario Agostino Gemelli
Rome
Ospedale SS Annunziata
Sassari
Azienda Ospedaliera Universitaria - Ospedale Riuniti
Trieste, TS, 34121
A.O. Ospedale di Circolo e Fondazione Macchi
Varese, VA, 21100
About this study
Official title: 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.
Read more
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
- Being tested
- E-learning educational program, Control
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-learning educational programOther
Also called Dr Sim
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.
ControlOther
Any educational program will be delivered to clinicians assigned to control arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, up to 1 year
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 month follow up
Re-hospitalization rate
proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge
Measured: 6 month follow up
Minor bleeding events
proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)
Measured: 6 month follow up
Major bleeding event
proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Sep 2017
- Primary completion22 Jan 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Simulation TrainingStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- cluster randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Santalucia, MD, Principal investigator, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188211
- Sponsor's protocol ID
- BMS ISR # CV185-483
- Acronym
- SIM-AF
- Status last verified
- Nov 2018
- First submitted
- 5 Jun 2017
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29657108Antoniazzi 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.
PubMed 31218738Franchi 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.
PubMed 31075225
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-based Technologies to Improve the Appropriate Use of Oral Anticoagulants in Hospitalized Elderly Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03188211
- Acronym / sponsor ID
- SIM-AF / BMS ISR # CV185-483
- Conditions
- Simulation Training, Anticoagulant Drugs, Elderly, Atrial Fibrillation, Drug Prescriptions, Internal Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: E-learning educational programClinicians 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. |
| Control | Other | Other: ControlClinicians allocated to control arm will not receive the e-learning educational program based on simulation-based technologies (Dr Sim). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-learning educational programAlso: Dr SimA 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 | Intervention |
| ControlAny educational program will be delivered to clinicians assigned to control arm | Other | Control |
Primary outcome
Elderly with AF prescribed with OAC
Time frame: through study completion, up to 1 year
difference in the proportion of elderly patients with AF prescribed with OAC between the post-intervention and the pre-intervention observational phase
8 secondary outcomes
Number of access to Dr Sim
Time frame: 1 month
Total duration of connection to Dr Sim
Time frame: 1 month
Elderly patients with AF prescribed with any antiplatelet agent
Time frame: through study completion, up to 1 year
Elderly patients with AF newly prescribed with OAC agents
Time frame: through study completion, up to 1 year
Patients experiencing any cerebro or cardiovascular events
Time frame: 6 month follow up
Re-hospitalization rate
Time frame: 6 month follow up
Minor bleeding events
Time frame: 6 month follow up
Major bleeding event
Time frame: 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Results publication: PubMed 29657108Proietti 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.
- Derived from this study: PubMed 31218738Antoniazzi 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.
- Derived from this study: PubMed 31075225Franchi 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.
- Letters to EditorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Santalucia, MD principal investigator
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-learning educational program in people with Simulation Training and Anticoagulant Drugs, run by Mario Negri Institute for Pharmacological Research at 20 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Elderly with AF prescribed with OAC (time frame: through study completion, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188211, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2018.