ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

Treatment: Other

Intervention code [2]

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]

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]

immediately after psychometric testing (baseline), and at 1 month post baseline

Secondary outcome [1]

proficiency score of bronchoscopy performance, based on global rating scale

Timepoint [1]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Hospital Department of Anaesthesia

Address [1]

Level 1, New Clinical Building,
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country [1]

Australia

Primary sponsor type

Hospital

Name

Liverpool Hospital

Address

Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South West Sydney HREC

Ethics committee address [1]

‘Research and Ethics Office’
Locked Bag 7103
LIVERPOOL BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

24/06/2016

Approval date [1]

22/11/2016

Ethics approval number [1]

Summary

Brief summary

Flexible video fibreoptic bronchoscopy (FOB) is an important component of the airway skills required by doctors in the area of critical care, including anaesthetists, intensive care physicians, and in emergency medicine. Speed and accuracy of performance, as well as causing no trauma to the patient's airway, is essential to secure the airway for adequate oxygenation and ventilation. However, FOB skills are often learnt in an unstructured format by trainees, and clinical exposure is limited by their relative rarity, causing skills decay after initial training. 
  In this study, we are examining if training in FOB skills can be improved based on the innate visuospatial and psychomotor abilities of doctors. Other procedural tasks in medicine, similar in complexity to FOB, have previously been shown to be associated with these cognitive abilities as they influence hand-eye dexterity and motor skills. 
  An educational intervention will be provided to those novices identified with lower visuospatial and psychomotor abilities, to determine if these novices can be brought up to the same level of FOB performance as their higher ability colleagues. This training is based on mental rehearsal of the procedure, which has been used by professional athletes, musicians, and by surgeons where they "practice" the performance in their heads before they actually perform it in real life. 
  This study will recruit doctors rotating into critical care areas where FOB skill is necessary (anaesthesia, intensive care, emergency medicine). Visuospatial and psychomotor ability will be assessed by a standardised test battery. For doctors stratified into the low ability cohort of visuospatial and psychomotor ability, mental imagery training will be provided. FOB performance is measured using an anatomically correct, benchtop manikin of the human airway. Primary endpoint of performance is time taken to successfully perform a FOB task, and secondary endpoint is proficiency as evaluated by blinded assessors using a validated global rating scale.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 407743668

Fax

a.chuan@unsw.edu.au

Contact person for public queries

Name

Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 2 9828 3173

Fax

a.chuan@unsw.edu.au

Contact person for scientific queries

Name

Alwin Chuan

Address

Department of Anaesthesia
Room 124, Level 1, New Clinical Building
Liverpool Hospital
Elizabeth Street
Liverpool
NSW 2170

Country

Australia

Phone

+61 407743668

Fax

a.chuan@unsw.edu.au

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

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No additional documents have been identified.

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