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Trial record 36 of 560 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

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

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ClinicalTrials.gov Identifier: NCT03976388
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Hospital de Simulación, Universidad Andres Bello
Information provided by (Responsible Party):
Felipe Martinez Lomakin, Universidad Nacional Andres Bello

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.

Condition or disease Intervention/treatment Phase
Medical Education Device: Clinical Virtual Simulator Other: Small-Group Discussion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Other
Official Title: Virtual Clinical Simulation Amongst Undergraduate Medical Students
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 30, 2019

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 Name: 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.




Primary Outcome Measures :
  1. 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. 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.

  3. 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 Outcome Measures :
  1. 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. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976388


Contacts
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Contact: Felipe Martinez, MD, MSc 2845239 ext +56 32 f.martinez.lomakin@gmail.com
Contact: Marcela Imbarack, RN 2845239 ext +56 32 marcela.imbarack@unab.cl

Locations
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Chile
Hospital de Simulación, Universidad Andrés Bello Recruiting
Viña del Mar, Valparaíso, Chile, 2531015
Contact: Marcela Imbarack, RN    2845239 ext +56 32    marcela.imbarack@unab.cl   
Contact: Patricio Sepúlveda    2845239 ext + 56 32    p.sepulvedaguajardo@uandresbello.edu   
Sub-Investigator: Juan Pablo Soto, MD         
Sub-Investigator: Daniella Valenzuela, MD         
Sub-Investigator: Nicolás González, MD         
Sub-Investigator: Jorge Corsi, MD         
Sub-Investigator: Patricio Sepulveda         
Sponsors and Collaborators
Universidad Nacional Andres Bello
Hospital de Simulación, Universidad Andres Bello
Investigators
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Study Director: Felipe Martinez, MD, MSc Universidad Andres Bello

Publications:
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Responsible Party: Felipe Martinez Lomakin, Principal Investigator, Universidad Nacional Andres Bello
ClinicalTrials.gov Identifier: NCT03976388     History of Changes
Other Study ID Numbers: UNAB-001
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Felipe Martinez Lomakin, Universidad Nacional Andres Bello:
Virtual reality
Clinical simulation
Adherence
Guidelines