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

November 8, 2018 updated by: Mario Negri Institute for Pharmacological Research

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
247

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
through study completion, up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of access to Dr Sim
Time Frame: 1 month
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
Time Frame: 1 month
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
Time Frame: through study completion, up to 1 year
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
Time Frame: through study completion, up to 1 year
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
Time Frame: 6 month follow up
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
Time Frame: 6 month follow up
proportion of patients re-hospitalised for any cause during the 6 months after the hospital discharge
6 month follow up
Minor bleeding events
Time Frame: 6 month follow up
proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)
6 month follow up
Major bleeding event
Time Frame: 6 month follow up
proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)
6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mario Negri Institute for Pharmacological Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paola Santalucia, MD, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 22, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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