- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605380
Learning Management of Open Fractures on Virtual Patient
January 22, 2024 updated by: Kapil Sugand, Imperial College Healthcare NHS Trust
Validating Virtual World Simulation to Assess Decision-making of Managing an Open Lower Limb Fracture: a Prospective Cohort Study
- A novel virtual world programme with over 240 multiple choice questions was developed to assess the competencies in managing an open fracture of the lower limb according to the British Orthopaedic Association Standards for Trauma (BOAST) and Advanced Trauma Life support (ATLS) guidelines.
- A longitudinal, observational, multi-centre prospective cohort study was conducted at Imperial College London.
- Primary objective consisted of objective scores calculated in real-time from the 240 multiple choice questions between Novices, Intermediates and Experts.
- Participants who had either completed ATLS training, or had familiarised themselves with BOAST guidelines were also identified and correlated with objective scores.
Study Overview
Status
Suspended
Intervention / Treatment
Detailed Description
This is a multi-centre prospective randomised controlled educational trial observing for validity and training effect of managing an orthopaedic emergency using a virtual patient within an online world.
Cohorts consist of junior, intermediate and expert surgeons being tested on 240 multiple choice questions to assess for competency as well as face, content and construct validity.
Study Type
Observational
Enrollment (Actual)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Imperial College Healthcare NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
24 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Postgraduate orthopaedic trainees and Attendings/Consultants
Description
Inclusion Criteria:
- Postgraduate orthopaedic trainees and naïve to surgical simulation
Exclusion Criteria:
- undergraduates and previous exposure to surgical simulation involving cognitive task analysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Novices
Junior doctors/interns
|
Virtual patient with open fracture inside a virtual world
|
|
Intermediates
Specialist trainees/Residents
|
Virtual patient with open fracture inside a virtual world
|
|
Experts
Consultants/Attendings
|
Virtual patient with open fracture inside a virtual world
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective test score
Time Frame: Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt
|
Objective real-time performance test scores from 240 multiple choice questions (MCQs) on each step of managing virtual patient in virtual online world.
The MCQs will either be true or false.
Each correct answer will score one mark.
There will be no negative marking.
The scores will correlate with performance.
|
Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kapil Sugand, MRCS, Imperial College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Estimated)
June 1, 2024
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (Actual)
October 28, 2020
Study Record Updates
Last Update Posted (Actual)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 22, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VW01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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