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Trial registered on ANZCTR


Registration number
ACTRN12623000723684
Ethics application status
Approved
Date submitted
6/06/2023
Date registered
5/07/2023
Date last updated
15/08/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Live student-actor simulation versus video-based learning for Situational Awareness in Primary and allied Health care: Integration, Research and Education (SAPHIRE)
Scientific title
Effectiveness and dose-response of live student-actor simulation versus video-based learning for improving situational awareness in allied health students.
Secondary ID [1] 309832 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Education of health professional students 330260 0
Condition category
Condition code
Mental Health 327126 327126 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1) Student-actor simulated learning:
Students will be exposed to a simulated learning scenario where students play roles of patient or health professional or observer within the scenario. Students will be asked scripted prompting questions by a tutor from the Situation Awareness Global Assessment Technique during the simulated scenario. Students will be asked to respond verbally to the prompting questions which the facilitator will record on Qualtrics, but this will not be reviewed. Students will be asked to reflect on their experience within the scenario at the conclusion of the scenario. A simulated learning scenario will last for ~15 minutes. Individual student participants will be exposed to zero, one, two or three of these scenarios prior to their outcome measure scenario / assessment. Students who are exposed to more than one scenario will have them administered in back-to-back sessions, with an approximate 10 minute break in between each session.

Intervention 2) Video-based scenario learning:
Pre-recorded video materials of the same scenarios as for the student-actor simulated scenarios will be presented to a different set of student participants. The video materials will be uploaded onto the Qualtrics platform, where the students will be able to watch the videos while being presented with the same scripted prompting questions from the Situation Awareness Global Assessment Technique. Students will be asked to type their answers on the Qualtrics platform however these will not be reviewed. Students will be asked to reflect on their experience within the video scenario at the conclusion of watching it. The video-based simulated learning scenario will last for ~15 minutes. Individual student participants will be exposed to zero, one, two or three of these scenarios prior to their outcome measure scenario / assessment. Students who are exposed to more than one scenario will have them administered in back-to-back sessions, without a break in between each session beyond the period of reflection conducted after each.
Intervention code [1] 326265 0
Behaviour
Comparator / control treatment
We are using a dose-response comparison for each of the two intervention arms being compared.
Student participants will be randomized into groups of either:
1) 3 x 15 minute student-actor simulated learning scenarios
2) 2 x 15 minute student-actor simulated learning scenarios
3) 1 x 15 minute student-actor simulated learning scenarios
4) 3 x 15 minute video-based scenario learning activities
5) 2 x 15 minute video-based scenario learning activities
6) 1 x 15 minute video-based scenario learning activities
7) No student-actor simulated learning scenarios or video-based scenario learning activities

Random allocation will take place in a 1:1:1:1:1:1:1 ratio respectively across these groups
Control group
Dose comparison

Outcomes
Primary outcome [1] 334998 0
Situation Awareness Global Assessment Technique score
Timepoint [1] 334998 0
During completion of a final simulated scenario conducted in a student-actor format where the student is acting as the health professional in the scenario.
This final simulated scenario will be the same for all student participants and will not be the same as any of the scenarios they may have been exposed to as a part of one of the intervention conditions.
Secondary outcome [1] 422662 0
Graded mark on a study-specific written reflection asking for the participant's interpretation of the simulated scenario,
Timepoint [1] 422662 0
Following completion of a final simulated scenario conducted in a student-actor format where the student is acting as the health professional in the scenario.
This final simulated scenario will be the same for all student participants and will not be the same as any of the scenarios they may have been exposed to as a part of one of the intervention conditions.

Eligibility
Key inclusion criteria
Allied health professional students studying at Monash University, School of Primary and Allied Health Care, in Australia.
These students will be in the 2nd, 3rd or 4th year of study within the course areas of Paramedics, Physiotherapy, Occupational Therapy, Social Work or Medical Imaging.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
The sequence will be generated by a person who is not the trial analyst. Participant allocation will be revealed to individual participants following completion of the baseline demographics survey. Data collectors / assessors for the primary and secondary outcome will be remain blinded to the allocation sequence and allocation status of individual student participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated, permuted block randomisation in block sizes of 4, 6 or 8.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
comparative effectiveness (two groups - video-based or student actor simulation) with dose-response (4 levels - 0, 1, 2, or 3 preparatory scenarios prior to participating in the final assessment scenario)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary analysis will be a direct comparison between intervention approaches (student actor simulation, video-based), and across the number of scenarios student participants are exposed to. This analysis will follow the format of a factorial trial analysis plan with two factors (intervention approach, number of scenarios). It will exclude data from the zero session control group. We will use a linear regression analysis approach that includes both of these factors in the same model. This analysis will be followed by the same analysis but with an "intervention approach-by-number of sessions" interaction term included in the model. If this interaction term is not significant, then the result from the first "main effects" analysis will be considered the primary analysis result. If the interaction term is significant, then the pairwise, simple effects contrasts will be regarded as the primary analysis result. Regardless, following previous recommendations (Kahan BC, Tsui M, Jairath V, Scott AM, Altman DG, Beller E, Elbourne D. Reporting of randomized factorial trials was frequently inadequate. Journal of Clinical Epidemiology. 2020;117:52-9.) we will still report on all main effect, interaction effect, and simple effect results regardless of what is considered the primary analysis result.
Secondary analyses: We will characterise the dose-response curve for each intervention approach (student actor simulation, video-based) across the number of sessions provided using descriptive statistics (mean, standard deviation) and visual analysis for linear vs non-linear dose-response curves.
Where a linear relationship is identified within one of our intervention approaches (student actor simulation, video-based), we will seek to estimate the gradient of the dose response curve using linear regression analyses treating the number of sessions received as a continuous variable so that we can express the degree of improvement in our primary outcome associated with transitioning across each of the number of scenarios received. Where a non-linear relationship is identified, simple pairwise comparisons between the number of scenarios received will be examined.
We will estimate the cost per quality-adjusted student educated using the approach described previously (Haines TP, Isles R, Jones A, Jull G. Economic consequences in clinical education. Focus on Health Professional Education: A Multi-disciplinary Journal. 2011 Mar;12(3):53-63.).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/07/2023
Actual
17/07/2023
Date of last participant enrolment
Anticipated
15/09/2023
Actual
Date of last data collection
Anticipated
15/09/2023
Actual
Sample size
Target
140
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314016 0
University
Name [1] 314016 0
Monash University
Country [1] 314016 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Room 304, Building G, Peninsula Campus, Monash University, Frankston, Victoria, 3199
Country
Australia
Secondary sponsor category [1] 315925 0
None
Name [1] 315925 0
None
Address [1] 315925 0
None
Country [1] 315925 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313153 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313153 0
Ethics committee country [1] 313153 0
Australia
Date submitted for ethics approval [1] 313153 0
18/05/2023
Approval date [1] 313153 0
08/06/2023
Ethics approval number [1] 313153 0
38408

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

Contacts
Principal investigator
Name 127178 0
Prof Terry Haines
Address 127178 0
Room 304, Building G, Peninsula Campus, Monash University, Frankston, Victoria, 3199
Country 127178 0
Australia
Phone 127178 0
+61433596526
Fax 127178 0
Email 127178 0
[email protected]
Contact person for public queries
Name 127179 0
Terry Haines
Address 127179 0
Room 304, Building G, Peninsula Campus, Monash University, Frankston, Victoria, 3199
Country 127179 0
Australia
Phone 127179 0
+61433596526
Fax 127179 0
Email 127179 0
[email protected]
Contact person for scientific queries
Name 127180 0
Terry Haines
Address 127180 0
Room 304, Building G, Peninsula Campus, Monash University, Frankston, Victoria, 3199
Country 127180 0
Australia
Phone 127180 0
+61433596526
Fax 127180 0
Email 127180 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and secondary outcome data.
When will data be available (start and end dates)?
Following trial completion and acceptance of publication of results. There is no end date.
Available to whom?
General public.
Available for what types of analyses?
Meta-analyses.
How or where can data be obtained?
Researcher profile / university web-site.
https://www.monash.edu/medicine/spahc/about-us/school-staff/thaines


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.