NCT03976388

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

May 31, 2019

Last Update Submit

October 22, 2019

Conditions

Medical Education

Keywords

Virtual realityClinical simulationAdherenceGuidelines

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

Study Arms (2)

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.

Device: Clinical Virtual Simulator

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.

Other: Small-Group Discussion

Interventions

Clinical Virtual SimulatorDEVICE

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

Also known as: BodyInteract(R)
Clinical virtual simulator
Small-Group DiscussionOTHER

Small group discussion led by a physician.

Standard educational session

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Simulación, Universidad Andrés Bello

Viña del Mar, Región de Valparaíso, 2531015, Chile

Location

Related Publications (4)

  • 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.

    PMID: 21900138BACKGROUND

  • 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.

    PMID: 25748973BACKGROUND

  • 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.

    PMID: 28979666BACKGROUND

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

    PMID: 9543805BACKGROUND

Study Officials

  • Felipe Martinez, MD, MSc

    Universidad Andres Bello

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2019

First Posted

June 6, 2019

Study Start

July 1, 2019

Primary Completion

August 30, 2019

Study Completion

October 15, 2019

Last Updated

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)