Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virtual Clinical Simulation Amongst Undergraduate Medical Students

Conditions
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Medical Education

Intervention / Treatment
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* Device: Clinical Virtual Simulator
* Other: Small-Group Discussion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical virtual simulator<br>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<br>* Interactive medical case delivered using touch-sensitive screens in small group sessions.<br>* Other names: BodyInteract(R);|
| Active Comparator: Standard educational session<br>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<br>* Small group discussion led by a physician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with passing grades in an Objective Structured Clinical Examination (OSCE) | 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) | 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 | 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 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 required to implement specific diagnostic and therapeutic interventions relevant to the clinical scenario | 2 weeks after attending the educational session. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Clinical simulation, Adherence, Guidelines