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

Medical Education Clinical Trial

— VIRTUE-Pilot  

Official title:

Virtual Clinical Simulation Amongst Undergraduate Medical Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976388
• Other study ID #: UNAB-001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: Universidad Nacional Andres Bello
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 15, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Medical Education

Intervention

Device:
• Clinical Virtual Simulator
Interactive medical case delivered using touch-sensitive screens in small group sessions.

Other:
• Small-Group Discussion
Small group discussion led by a physician.

Locations

Country	Name	City	State
Chile	Hospital de Simulación, Universidad Andrés Bello	Viña del Mar	Valparaíso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Andres Bello	Hospital de Simulación, Universidad Andres Bello

Country where clinical trial is conducted

Chile, 

References & 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. Review. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.