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

NCT ID: NCT03976388

Last Updated: 2019-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2019-10-15

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.

Conditions

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Medical Education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical Virtual Simulator

Intervention Type DEVICE

Interactive medical case delivered using touch-sensitive screens in small group sessions.

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.

Group Type ACTIVE_COMPARATOR

Small-Group Discussion

Intervention Type OTHER

Small group discussion led by a physician.

Interventions

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Clinical Virtual Simulator

Interactive medical case delivered using touch-sensitive screens in small group sessions.

Intervention Type DEVICE

Small-Group Discussion

Small group discussion led by a physician.

Intervention Type OTHER

Other Intervention Names

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BodyInteract(R)

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Simulación, Universidad Andres Bello

UNKNOWN

Sponsor Role collaborator

Universidad Nacional Andres Bello

OTHER

Sponsor Role lead

Responsible Party

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Felipe Martinez Lomakin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Felipe Martinez, MD, MSc

Role: STUDY_DIRECTOR

Universidad Andres Bello

Locations

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Hospital de Simulación, Universidad Andrés Bello

Viña del Mar, Región de Valparaíso, Chile

Site Status

Countries

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Chile

References

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Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.

Reference Type BACKGROUND
PMID: 21900138 (View on PubMed)

Lopreiato JO, Sawyer T. Simulation-based medical education in pediatrics. Acad Pediatr. 2015 Mar-Apr;15(2):134-42. doi: 10.1016/j.acap.2014.10.010.

Reference Type BACKGROUND
PMID: 25748973 (View on PubMed)

Li L, Yu F, Shi D, Shi J, Tian Z, Yang J, Wang X, Jiang Q. Application of virtual reality technology in clinical medicine. Am J Transl Res. 2017 Sep 15;9(9):3867-3880. eCollection 2017.

Reference Type BACKGROUND
PMID: 28979666 (View on PubMed)

Edvardsen O, Steensrud T. [Virtual reality in medical education]. Tidsskr Nor Laegeforen. 1998 Feb 28;118(6):902-6. Norwegian.

Reference Type BACKGROUND
PMID: 9543805 (View on PubMed)

Other Identifiers

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UNAB-001

Identifier Type: -

Identifier Source: org_study_id

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