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Clinical Trials/NCT03976388
NCT03976388CompletedNot Applicable

Virtual Clinical Simulation Amongst Undergraduate Medical Students

Universidad Nacional Andres Bello1 site in 1 country50 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Number of participants with passing grades in an Objective Structured Clinical Examination (OSCE)

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Investigator, Outcomes Assessor)

Masking Description

Outcome assessors, analysts and investigators will be masked in this trial. Due to the intervention's characteristics, it has been deemed impossible to mask participants.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Clinical virtual simulator

Experimental

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.

Intervention: Clinical Virtual Simulator (Device)

Standard educational session

Active Comparator

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.

Intervention: Small-Group Discussion (Other)

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Time to solve the clinical scenario(2 weeks after attending the educational session.)
  • Time to deliver specific interventions(2 weeks after attending the educational session.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Felipe Martinez Lomakin

Principal Investigator

Universidad Nacional Andres Bello

Study Sites (1)

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