ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12617000861358

Ethics application status

Approved

Date submitted

6/06/2017

Date registered

13/06/2017

Date last updated

8/07/2021

Date data sharing statement initially provided

8/07/2021

Date results provided

8/07/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Can we use a test of spatial relationships to identify future doctors who might benefit from increased training to better perform ultrasound-guided regional anaesthesia?

Scientific title

Does Targeted Educational Intervention based on Psychometric Screening Improve Ultrasound-Guided Regional Anaesthesia Performance in medical students?

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

medical students with low spatial relationships as screened using the Mental Rotations Test-A

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

In this prospective, multicentre, 1:1 allocation, double blinded, stratified randomised interventional (non-drug) trial, we will perform screening of innate spatial relationships on medical students ("participants") recruited into the study. This is performed using the revised Mental Rotations Test-A (MRTA). This paper and pen based form is validated and standardised for visuopatial skills testing. The test is timed, has explicit instructions to be read out verbatim to participants, and the entire test takes 15 minutes.

Using population norms, participants are stratified into low (below mean) and high (above mean) ability groups. Participants are then randomised into control (discovery learning) or intervention (deliberate practice) training, creating 4 groups: low-control, low-intervention, high-control, and high-intervention.

Each participant will then be brought individually to an identical in vitro benchtop pork model and be asked to perform an ultrasound-guided regional anaesthesia (UGRA) needle task. The attempt will be recorded as time taken (seconds), and evaluated using a global rating scale previously used for UGRA assessment. This is the baseline test.
Physician anaesthetists who are experts in UGRA will conduct these assessments. This will be assessed in real-time, while the participant performs the task. These “examiners” are blinded to participant MRTA scores and group allocation. The examiners are not involved in any other training of participants.

After performance of baseline testing, the intervention group receives deliberate practice in UGRA skills. Deliberate practice is a technique of 1 on 1 teaching by expert faculty using graded goals and providing feedback after every attempt. This training period lasts 20 minutes. Faculty are also physician anaesthetists, not involved in assessment. The control group receives discovery learning, an educational technique where participants explore how to perform the UGRA task by themselves. They will also have 20 minutes of discovery training.

After training, all participants are brought back to the benchtop model and asked to repeat the UGRA task. They will be timed and their procedural skill assessed using the global rating scale by the examiner anaesthetists. This is the final test.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group receives discovery learning. This group is allowed the same time (20min), access to identical models and equipment as the intervention group. However, no expert faculty is involved with discovery learning.

Control group

Active

Outcomes

Primary outcome [1]

Time taken to complete the UGRA task, recorded on a stopwatch by a research assistant from picking up the needle and injecting saline into the 6- and 12-o'clock positions of the in vitro nerve benchtop model

Timepoint [1]

immediately after MRTA screening (baseline test), and after exposure to educational control or intervention (final)

Secondary outcome [1]

proficiency score on a global rating scale

Timepoint [1]

at baseline, and at final tests

Eligibility

Key inclusion criteria

medical students

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Participants with any previous training, tutorials, workshops or actual performance of UGRA.
Participants with prior psychometric or neurocognitive testing in the past 12 months.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Participant allocation is concealed by using sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

stratified randomisation. Stratification by visuospatial ability. Then randomisation by computerised allocation into groups

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering 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

Determining the effect of targeted deliberate practice will be assessed using repeated measures mixed ANOVA of the primary endpoint of time taken to complete the UGRA task from baseline to final testing. Thus, the comparisons will be between the low-intervention and high-intervention groups, and between the low-intervention and high-control groups.

The effect of targeted deliberate practice on the secondary endpoint of global rating scores between the low-intervention and high-intervention groups, and between the low-intervention and high-control groups, will use repeated measures ANOVA.

To measure the effect of deliberate practice as an educational intervention versus no training, comparisons will be made between the low-intervention and low-control groups, and between the high-intervention and high-control groups. These analyses will use repeated measures mixed ANOVA for time taken, and for global rating scale scores.
All analyses will use Bonferroni corrected, two-tailed p values < 0.05 for statistical significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/09/2017

Actual

1/01/2018

Date of last participant enrolment

Anticipated

Actual

26/05/2019

Date of last data collection

Anticipated

Actual

26/05/2019

Sample size

Target

140

Accrual to date

Final

140

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment outside Australia

Country [1]

Canada

State/province [1]

Ontario

Country [2]

Ireland

State/province [2]

Cork

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

Liverpool Hospital
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 Western 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]

19/06/2017

Approval date [1]

01/08/2018

Ethics approval number [1]

Summary

Brief summary

Ultrasound-guided regional anaesthesia (UGRA) is a complex procedural skill to learn. A diverse and extensive mix of knowledge, motor skills, cognitive planning, and mental reconstruction of anatomical structures is necessary. Successful performance of UGRA thus requires hand-eye coordination and interpreting 3-dimensional anatomy using 2-dimensional ultrasound images. 

Currently, an UGRA teaching curriculum is taught to all novices at an institution. However, novices learn at different rates and are receptive to different styles of teaching. Learning curves in UGRA consistently demonstrate a large inter-individual variation in proficiency and error rates, despite all novices receiving instruction from the same expert faculty.

One possible reason for this wide variability is the innate psychometric ability of novices. Psychometric ability is a subset of human intelligence, further divided into visuospatial and psychomotor abilities. Visuospatial ability is the capacity to generate, retrieve, and process visual information. Psychomotor ability influences the accuracy, reaction speed, and coordination required to control objects through hand-eye coordination. In complex tasks, innate differences in psychometric ability could contribute as much as 40% of differences in inter-individual learning speed and performance.

Previous studies suggest that a) visuospatial abilities are a better predictor of UGRA performance than psychomotor abilities, and b) certain visuospatial factors are more predictive of UGRA performance than others, specifically spatial visualisation (e.g., the ability to visualize and rotate 3-dimensional objects based on 2-dimensional images).  

There is evidence in other complex medical procedures that visuospatial ability influences performance, with shorter times taken to complete procedures and reduction in errors. 10-12 These procedures include laparoscopic surgery, plastic reconstructive surgery, 15 basic surgical knot tying, colonoscopy and gastroscopy. Of these numerous psychometric tests, the MRTA remained consistently useful in discriminating low and high ability novices, and has the advantage of extensive population data. 

An unexplored avenue in UGRA education research is thus being able to identify novices for which the UGRA task will be difficult to learn. Early identification may allow training to be individualised, allowing educators to target and allocate scarce training resources to novices who will benefit greatly from extra attention. 

In this study, we will be recruiting medical students without prior exposure to UGRA. We will use the MRTA to assess participants’ visuospatial ability. Participants will then be randomised into a control group (no training) and a deliberate practice group.

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

+61407743668

Fax

[email protected]

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

+61407743668

Fax

[email protected]

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

+61407743668

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12469	Ethical approval			[email protected]

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically