Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial (VIRTUE-Pilot)

October 22, 2019 updated by: Felipe Martinez Lomakin, Universidad Nacional Andres Bello

Virtual Clinical Simulation Amongst Undergraduate Medical Students

In this trial, undergraduate medical students will be randomised to undergo training using a virtual reality simulator (BodyInteract®) or a standard small-group interactive discussion of a clinical scenario. Adherence to current clinical recommendations will be considered as primary outcomes for this study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To assess whether a virtual reality simulator might facilitate learning and improve adherence to current clinical guidelines. Methodology: A double-masked randomised trial will be held among students at the School of Medicine of the Universidad Andres Bello. Participants will be randomised to receive training using a clinical virtual simulator (Body Interact®, Body Interact Inc, Austin, TX) designed to review key concepts in Cardiology. Students allocated to the control group will receive a small-group discussion lasting up to 60 minutes in which key topics regarding the same clinical condition will be reviewed as well. Main outcomes include the overall performance in an objective structured clinical examination (OSCE) that will be reviewed by an expert panel prior to its implementation and adherence to specific recommendations in current national guidelines. This OSCE will be held 15 days after the educational session has taken place. Analyses will be undertaken under the intention to treat principle and missing data will be handled using multiple imputation techniques.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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

  • Chile
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile, 2531015
        • Hospital de Simulación, Universidad Andrés Bello

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergraduate medical student at the Universidad Andrés Bello
  • Currently undergoing the 4th or 5th year of medical training in Chile
  • Obtained a passing grade in Cardiology for general physicians.

Exclusion Criteria:

  • Refusal to participate.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinical virtual simulator
A clinical virtual simulator contains an interactive medical case depicting an acutely ill patient seeking care at the emergency department. The case will be delivered in small groups (up to 6 participants) in sessions lasting up to 20 minutes. After the simulation has been completed, a feedback session lasting up to 30 minutes will be delivered as well.
Device: Clinical Virtual Simulator
Interactive medical case delivered using touch-sensitive screens in small group sessions.
Other Names:
  • BodyInteract(R)
Active Comparator: Standard educational session
A small-group discussion (up to 6 participants) using patients with the same condition as the one selected for the clinical simulator will be held for participants allocated to the control group. These sessions will be led by a physician and have a maximum duration of up to 60 minutes.
Other: Small-Group Discussion
Small group discussion led by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with passing grades in an Objective Structured Clinical Examination (OSCE)
Time Frame: 2 weeks after attending the educational session.
Number of participants with marks over 60% in an OSCE.
2 weeks after attending the educational session.
Marks attained in an Objective Structured Clinical Examination (OSCE)
Time Frame: 2 weeks after attending the educational session.
Marks attained in an OSCE depicting the clinical scenario described in educational sessions. In this examination, the implementation of diagnostic and therapeutic interventions will score marks that will then be compared between groups.
2 weeks after attending the educational session.
Adherence to guideline recommendations
Time Frame: 2 weeks after attending the educational session.
Adherence to specific recommendations in national guidelines relevant to the diagnosis and management of the clinical condition being studied.
2 weeks after attending the educational session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to solve the clinical scenario
Time Frame: 2 weeks after attending the educational session.
Time required to solve the clinical scenario depicted in the Objective Structured Clinical Examination
2 weeks after attending the educational session.
Time to deliver specific interventions
Time Frame: 2 weeks after attending the educational session.
Time required to implement specific diagnostic and therapeutic interventions relevant to the clinical scenario
2 weeks after attending the educational session.

Collaborators and Investigators

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

Sponsor

Universidad Nacional Andres Bello

Collaborators

Hospital de Simulación, Universidad Andres Bello

Investigators

  • Study Director: Felipe Martinez, MD, MSc, Universidad Andrés Bello

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

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)

July 1, 2019

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UNAB-001

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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