Educational ProblemsNCT04605380
Learning Management of Open Fractures on Virtual Patient
An observational study of Educational Problems and Simulation of Physical Illness, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Problems, Simulation of Physical Illness, Fractures, Bone
- What is being tested?
- Virtual reality online world
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 1 Jun 2026
- Phase
- Observational
- 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 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postgraduate orthopaedic trainees and Attendings/Consultants
Who may be able to join
- Postgraduate orthopaedic trainees and naïve to surgical simulation
Who cannot join
- undergraduates and previous exposure to surgical simulation involving cognitive task analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Virtual reality online world
- Keywords
- virtual reality, simulation, resuscitation
- Medical subject headings
- Fractures, Bone, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality online worldOther
Virtual patient with open fracture inside a virtual world
| Study group | Role | What they receive |
|---|---|---|
| Novices | Junior doctors/interns Receives: Other: Virtual reality online world | |
| Intermediates | Specialist trainees/Residents Receives: Other: Virtual reality online world | |
| Experts | Consultants/Attendings Receives: Other: Virtual reality online world |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective test score
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.
Measured: Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2026 (estimated)
Why it stopped: COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kapil Sugand, Imperial College Healthcare NHS Trust
- Investigators
- Kapil Sugand, MRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605380
- Sponsor's protocol ID
- VW01
- Status last verified
- Jan 2024
- First submitted
- 15 Oct 2020
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating Virtual World Simulation to Assess Decision-making of Managing an Open Lower Limb Fracture: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04605380
- Acronym / sponsor ID
- VW01
- Keywords
- virtual reality, simulation, resuscitation
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: COVID pandemic
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Oct 2020 (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.
- 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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Novices | – | Other: Virtual reality online worldJunior doctors/interns |
| Intermediates | – | Other: Virtual reality online worldSpecialist trainees/Residents |
| Experts | – | Other: Virtual reality online worldConsultants/Attendings |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postgraduate orthopaedic trainees and Attendings/Consultants
Key inclusion criteria (1 listed)
- Postgraduate orthopaedic trainees and naïve to surgical simulation
Key exclusion criteria (1 listed)
- undergraduates and previous exposure to surgical simulation involving cognitive task analysis
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 |
|---|---|---|
| Virtual reality online worldVirtual patient with open fracture inside a virtual world | Other | Experts, Intermediates, Novices |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- 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.
Kapil Sugand, MRCS principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Problems and Simulation of Physical Illness, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
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 1 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: paused, as of the sponsor's last update on 25 Jan 2024. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Objective test score (time frame: Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2024.