Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000882426
Ethics application status
Approved
Date submitted
29/06/2016
Date registered
5/07/2016
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we identify junior doctors with low visuospatial and psychomotor ability and provide extra skills training to allow them to perform fibreoptic bronchoscopy
Scientific title
Targeting educational intervention in fibreoptic bronchoscopy skills training based on visuospatial and psychomotor testing of junior doctors
Secondary ID [1] 289566 0
none
Universal Trial Number (UTN)
U1111-1184-7939
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Junior doctors with low visuospatial and low psychomotor ability 299296 0
Condition category
Condition code
Public Health 299291 299291 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this non-drug trial, we will perform psychometric testing on junior doctors recruited into the study. The testing is paper based and is a battery of norm based, standardised neuro-cognitive tests of innate visuospatial and psychomotor ability and administered by a trained neuropsychologist. Tests include the Mental Rotations A, Block Design, Matrix Reasoning, Zig-Zag, and Trail Making Tests A and B. All tests will take 45-60minutes.
Participants will then be stratified into low ability cohorts (defined as > 1 standard deviation below population mean). The low ability cohort will receive mental imagery training, which is a textually and graphically rich written script with step by step descriptions of the fibreoptic bronchoscopy procedure. Participants will be asked to read through and mentally rehearse each of the steps for 1 week. Training is via a paper booklet sent to participants. Each participant will be asked to perform mental imagery training daily for the 1 week, and should take approximately 15 minutes per rehearsal. Compliance will be audited by researchers at the end of the training week. This week of training will occur 3 weeks after psychometric baseline assessment; ie. 1 week prior to bronchoscopy testing.
All participants will then be asked to perform a fibreoptic bronchoscopy procedure on an anatomically correct bench top manikin. This performance will be timed and a video recorded of the performance for scoring by blinded experts using a validated global rating scale
Intervention code [1] 295162 0
Treatment: Other
Intervention code [2] 295163 0
Behaviour
Comparator / control treatment
The control group are junior doctors performing the same fibreoptic bronchoscopy task, but stratified as high ability on psychometric testing. The control group will not receive the additional mental imagery training
Control group
Active

Outcomes
Primary outcome [1] 298783 0
Time taken to complete the fibreoptic bronchoscopy task, recorded on stopwatch by a research assistant from picking up the bronchoscope to reaching the endpoint (successful intubation of the right and left main bronchus)
Timepoint [1] 298783 0
immediately after psychometric testing (baseline), and at 1 month post baseline
Secondary outcome [1] 325188 0
proficiency score of bronchoscopy performance, based on global rating scale
Timepoint [1] 325188 0
at baseline, and at 1 month post baseline

Eligibility
Key inclusion criteria
All junior doctors rotating into critical care terms at Liverpool Hospital, including rotations into anaesthesia, intensive care, and emergency medicine.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Has had previous training, workshops or actual performance of video fibreoptic bronchoscopy. Has had psychometric testing or neurocognitive testing in the past 12 months.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on individual scores in the psychometric tests, participants will be stratified by population norms into ‘low’ and ‘high’ ability cohorts. Sample size is based on population norms of psychometric tests used, which are normally distributed. We expect 12-15 participants in each low and high ability cohorts. No formal power calculation has been performed.
The time taken to successfully complete the task, and Global rating scale numerical scores, will be analysed against cohort by t tests or the Mann-Whitney U tests. Dichotomous satisfactory and unsatisfactory performance item in the global rating scale will be analysed against cohort by Fisher's exact test. Rate of improvement from baseline to 1-month performance for each cohort will be analysed by repeated measures ANOVA. Correlation between psychometric scores, time taken to complete the task, and GRS scores, will be analysed by Pearson or Spearman rank correlation. A two tailed, P value < 0.05 will be deemed significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2016
Actual
1/02/2017
Date of last participant enrolment
Anticipated
6/11/2017
Actual
6/11/2017
Date of last data collection
Anticipated
6/12/2017
Actual
6/12/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6035 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 13484 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 293942 0
Hospital
Name [1] 293942 0
Liverpool Hospital Department of Anaesthesia
Country [1] 293942 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Elizabeth Street
Liverpool
NSW 2170
Country
Australia
Secondary sponsor category [1] 292765 0
None
Name [1] 292765 0
Address [1] 292765 0
Country [1] 292765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295355 0
South West Sydney HREC
Ethics committee address [1] 295355 0
Ethics committee country [1] 295355 0
Australia
Date submitted for ethics approval [1] 295355 0
24/06/2016
Approval date [1] 295355 0
22/11/2016
Ethics approval number [1] 295355 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67006 0
Dr Alwin Chuan
Address 67006 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67006 0
Australia
Phone 67006 0
+61 407743668
Fax 67006 0
Email 67006 0
[email protected]
Contact person for public queries
Name 67007 0
Alwin Chuan
Address 67007 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67007 0
Australia
Phone 67007 0
+61 2 9828 3173
Fax 67007 0
Email 67007 0
[email protected]
Contact person for scientific queries
Name 67008 0
Alwin Chuan
Address 67008 0
Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170
Country 67008 0
Australia
Phone 67008 0
+61 407743668
Fax 67008 0
Email 67008 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.