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Trial registered on ANZCTR


Registration number
ACTRN12619000172101p
Ethics application status
Not yet submitted
Date submitted
14/03/2018
Date registered
6/02/2019
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of learning focused cardiac ultrasound between self-directed and proctored simulator teaching
Scientific title
Non-inferiority trial of image acquisition for teaching focused cardiac ultrasound to medical students with and without a supervised training workshop.
Secondary ID [1] 294334 0
N/A
Universal Trial Number (UTN)
Trial acronym
SIMTEACH3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical student lack of cardiac ultrasound knowledge 307052 0
cardiac disease 307054 0
Condition category
Condition code
Cardiovascular 306163 306163 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm1 - focused cardiac ultrasound simulator course that has the 3-hour proctored workshop replaced with an on-line self directed learning package
a) This package contains text, figures, videos, and automatically marked multiple choice question (MCQ) review test
b) The intervention is delivered as part of the course reading material and is performed before the ultrasound simulator training. The estimated time taken to complete the intervention is 1 hour.
c) There are no restrictions on access to the intervention, the online material can be accessed by a secure server (unique username and password for each participant) indefinitely as the resource is required to be reviewed during the ultrasound simulator practical training phase of the course
d) The delivery (completion by each participant) of the intervention will monitored and ensured completed for every participant by checking completion using the administrative database. To complete the intervention each participant must obtain an adequate passmark (>=80%) in the online tutorial self assessment MCQ test. These results are automatically recorded in the administrative database.
Intervention code [1] 300640 0
Treatment: Other
Comparator / control treatment
Arm2 - standard focused cardiac ultrasound simulator course that includes a 3-hour proctored workshop
- 3-hour supervised hands-on workshop with 5 participants per instructor (two researchers from the research team who are qualified ultrasound instructors) and ultrasound simulator.
- the participants are orientated to the operation of the ultrasound simulator and instructed on how to complete the 10 self-directed practice cases using their device to access the online course training material.
- adherence to the comparator will be checked and ensured by recording participant attendance at the workshop. Missing participants will be contacted and an alternative date will be arranged for their workshop as close to the original workshop date as possible.
- the workshop content is published in an online train the trainer instructor manual which will be followed exactly to ensure consistency of the content of the workshop.
Control group
Active

Outcomes
Primary outcome [1] 305176 0
Group mean image quality score.
a. Practical image acquisition assessment will be performed at the same time as the post-course knowledge base MCQ test at the Austin Medical School Simulator room and comprises performing and recording focused cardiac (transthoracic echocardiography) ultrasound images on a healthy male human volunteer. The images are saved and analysed off-line by two trained observers who are blinded to participant group allocation and image quality scores calculated using a validated tool, image quality score (Canty et al. J Crit Care 2019;49:38–44).
b. Researchers performing image quality assessment will be blinded to participant group allocation.
Timepoint [1] 305176 0
at completion of the simulator course (4 weeks after the intervention/control)
Secondary outcome [1] 344401 0
Knowledge base assessment is performed using a post-course MCQ exam (20 questions) will be assessed using Student's t-test. These MCQ's have been validated and published. Independent (two-way) Student's t-test will be used to compare group mean MCQ test result with significance set at P<0.01 to reduce type II error.
Timepoint [1] 344401 0
at completion of the simulator course (4 weeks after the intervention/control)
Secondary outcome [2] 344402 0
A cost effectiveness study (performed by a qualified health economist) will be performed comparing two courses. We will record the total amount of staff work hours for each type of training course, which will be converted to a dollar figure using hourly rates, as well as considering the costs of the simulator. Cost-effectiveness will be analysed in two ways:
a. the additional costs per additional test score on knowledge and performance of simulator learning vs. usual training; and
b. the additional costs per additional number of FCU exams on patients per unit time (data recorded 3 months after the course).
Timepoint [2] 344402 0
3 months after course completion
Secondary outcome [3] 344403 0
Participant satisfaction of the course is assessed by an on-line survey (three possible answers of either agree, neutral or disagree) performed at course completion and will be reported using qualitative assessment (frequency tables) rather than statistical comparison. Assessment includes student satisfaction of feasibility of self-directed training as opposed to supervised training, course content and confidence in cardiac ultrasound.
Timepoint [3] 344403 0
at completion of the simulator course (4 weeks after the intervention/control)

Eligibility
Key inclusion criteria
Second year medical student at University of Melbourne 2019 rotating through the Austin Hospital.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Researchers performing image quality assessment will be blinded to participant group allocation.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary endpoint
The non-inferiority assessment will involve the construction of a 95% confidence interval for the difference in group image quality score (in favour of the proctored group) to determine whether the interval falls wholly above -5%.

Secondary endpoints
Comparisons will also be performed for mean knowledge base MCQ test score of performance and mean satisfaction score rates, using a paired Student's t test with level of significance set at P<0.05. The MCQ test is performed before the course and at the end of the course and change in MCQ scores will also be assessed to investigate whether one group MCQ score increases more than the other group after the learning intervention.. A cost effectiveness study will be performed comparing self-directed and proctored simulator courses. We will record the total amount of staff work hours for each type of training course, which will be converted to a dollar figure using hourly rates, as well as considering the costs of the simulator.
Cost-effectiveness will be analysed in two ways: 1) the additional costs per additional test score on knowledge and performance of simulator learning vs. usual training; and 2) the additional costs per additional number of FCU exams on patients per unit time (data recorded 3 months after the course).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2019
Actual
Date of last participant enrolment
Anticipated
1/09/2020
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13032 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25527 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298977 0
Hospital
Name [1] 298977 0
Epworth Hospital Richmond
Country [1] 298977 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Ultrasound Education Group, Level 6 Centre for Medical Research, University of Melbourne, Royal Parade, Parkeville VIC 3050
Country
Australia
Secondary sponsor category [1] 301596 0
None
Name [1] 301596 0
Address [1] 301596 0
Country [1] 301596 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 299907 0
Human Ethics Advisory Group University of Melbourne
Ethics committee address [1] 299907 0
Ethics committee country [1] 299907 0
Australia
Date submitted for ethics approval [1] 299907 0
08/02/2019
Approval date [1] 299907 0
Ethics approval number [1] 299907 0

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

Contacts
Principal investigator
Name 81950 0
A/Prof David Canty
Address 81950 0
Ultrasound Education Group, Level 6 Centre for Medical Research, University of Melbourne, Royal Parade, Parkville VIC 3050
Country 81950 0
Australia
Phone 81950 0
+61429058878
Fax 81950 0
Email 81950 0
dj_canty@hotmail.com
Contact person for public queries
Name 81951 0
David Canty
Address 81951 0
Ultrasound Education Group, Level 6 Centre for Medical Research, University of Melbourne, Royal Parade, Parkville VIC 3050
Country 81951 0
Australia
Phone 81951 0
+61429058878
Fax 81951 0
Email 81951 0
dcanty@unimelb.edu.au
Contact person for scientific queries
Name 81952 0
David Canty
Address 81952 0
Ultrasound Education Group, Level 6 Centre for Medical Research, University of Melbourne, Royal Parade, Parkville VIC 3050
Country 81952 0
Australia
Phone 81952 0
+61429058878
Fax 81952 0
Email 81952 0
dcanty@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not required as a unique training course


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.