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Completed

NCT Number: NCT03188211

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Fondazione Poliambulanza, Brescia, BS, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Dr Sim

Control

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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

  7. Minor bleeding events

    Time frame: 6 month follow up

    proportion of patients experiencing a minor bleeding event during the 6 months after hospital discharge)

  8. Major bleeding event

    Time frame: 6 month follow up

    proportion of patients experiencing a major bleeding event during the 6 months after hospital discharge)

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

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

Acronym: SIM-AF

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2017
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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