NCT04605380

Brief 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.
  • 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Mar 2020Jun 2026

Study Start

First participant enrolled

March 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

4.3 years

First QC Date

October 15, 2020

Last Update Submit

January 22, 2024

Conditions

Keywords

virtual realitysimulationresuscitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after the intervention/procedure/surgery - objective test scores collected immediately after a single attempt

Study Arms (3)

Novices

Junior doctors/interns

Other: Virtual reality online world

Intermediates

Specialist trainees/Residents

Other: Virtual reality online world

Experts

Consultants/Attendings

Other: Virtual reality online world

Interventions

Virtual patient with open fracture inside a virtual world

ExpertsIntermediatesNovices

Eligibility Criteria

Age24 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postgraduate orthopaedic trainees and Attendings/Consultants

You may qualify if:

  • Postgraduate orthopaedic trainees and naïve to surgical simulation

You may not qualify if:

  • undergraduates and previous exposure to surgical simulation involving cognitive task analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Fractures, BoneEmergencies

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kapil Sugand, MRCS

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 28, 2020

Study Start

March 1, 2020

Primary Completion

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations