Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial (VIRTUE-Pilot)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03976388|
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Medical Education||Device: Clinical Virtual Simulator Other: Small-Group Discussion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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
- 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
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
|Contact: Felipe Martinez, MD, MSc||2845239 ext +56 firstname.lastname@example.org|
|Contact: Marcela Imbarack, RN||2845239 ext +56 email@example.com|
|Hospital de Simulación, Universidad Andrés Bello||Recruiting|
|Viña del Mar, Valparaíso, Chile, 2531015|
|Contact: Marcela Imbarack, RN 2845239 ext +56 32 firstname.lastname@example.org|
|Contact: Patricio Sepúlveda 2845239 ext + 56 32 email@example.com|
|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|
|Study Director:||Felipe Martinez, MD, MSc||Universidad Andres Bello|