Medical EducationVIRTUE-PilotNCT03976388
Virtual Clinical Simulation for Training Amongst Undergraduate Medical Students: A Pilot Randomised Trial
A study testing Clinical Virtual Simulator and Small-Group Discussion in people with Medical Education, run by Universidad Nacional Andres Bello at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Education
- What is being tested?
- Clinical Virtual Simulator and Small-Group Discussion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2019to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital de Simulación, Universidad Andrés Bello
Viña del Mar, Valparaiso, 2531015
About this study
Official title: Virtual Clinical Simulation Amongst Undergraduate Medical Students
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.
Read the 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.
- Conditions
- Medical Education
- Being tested
- Clinical Virtual Simulator, Small-Group Discussion
- Keywords
- Virtual reality, Clinical simulation, Adherence, Guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Virtual SimulatorDevice
Also called BodyInteract(R)
Interactive medical case delivered using touch-sensitive screens in small group sessions.
Small-Group DiscussionOther
Small group discussion led by a physician.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Small-Group Discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with passing grades in an Objective Structured Clinical Examination (OSCE)
Number of participants with marks over 60% in an OSCE.
Measured: 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.
Measured: 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.
Measured: 2 weeks after attending the educational session.
Secondary outcomes (2)
Time to solve the clinical scenario
Time required to solve the clinical scenario depicted in the Objective Structured Clinical Examination
Measured: 2 weeks after attending the educational session.
Time to deliver specific interventions
Time required to implement specific diagnostic and therapeutic interventions relevant to the clinical scenario
Measured: 2 weeks after attending the educational session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start1 Jul 2019
- Primary completion30 Aug 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Simulación, Universidad Andres Bello
- Responsible party
- Principal investigator, Felipe Martinez Lomakin, Universidad Nacional Andres Bello
- Investigators
- Felipe Martinez, MD, MSc, Study director, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976388
- Sponsor's protocol ID
- UNAB-001
- Acronym
- VIRTUE-Pilot
- Status last verified
- Oct 2019
- First submitted
- 31 May 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21900138Lopreiato 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.
PubMed 25748973Li 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.
PubMed 28979666Edvardsen O, Steensrud T. [Virtual reality in medical education]. Tidsskr Nor Laegeforen. 1998 Feb 28;118(6):902-6. Norwegian.
PubMed 9543805
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Clinical Simulation Amongst Undergraduate Medical Students
- ClinicalTrials.gov ID
- NCT03976388
- Acronym / sponsor ID
- VIRTUE-Pilot / UNAB-001
- Conditions
- Medical Education
- Keywords
- Virtual reality, Clinical simulation, Adherence, Guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Collaborators
- Hospital de Simulación, Universidad Andres Bello
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical virtual simulator | Experimental | Device: Clinical Virtual SimulatorA 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. |
| Standard educational session | Active comparator | Other: Small-Group DiscussionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Virtual SimulatorAlso: BodyInteract(R)Interactive medical case delivered using touch-sensitive screens in small group sessions. | Device | Clinical virtual simulator |
| Small-Group DiscussionSmall group discussion led by a physician. | Other | Standard educational session |
Primary outcome
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.
2 secondary outcomes
Time to solve the clinical scenario
Time frame: 2 weeks after attending the educational session.
Time to deliver specific interventions
Time frame: 2 weeks after attending the educational session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Background: PubMed 21900138Cook 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.
- Background: PubMed 25748973Lopreiato 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.
- Background: PubMed 28979666Li 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.
- Background: PubMed 9543805Edvardsen O, Steensrud T. [Virtual reality in medical education]. Tidsskr Nor Laegeforen. 1998 Feb 28;118(6):902-6. Norwegian.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Martinez, MD, MSc study director
Universidad Nacional Andres Bello
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Virtual Simulator and Small-Group Discussion in people with Medical Education, run by Universidad Nacional Andres Bello at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with passing grades in an Objective Structured Clinical Examination (OSCE) (time frame: 2 weeks after attending the educational session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976388, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.