Trial Review

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
ACTRN12619000048189
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
15/01/2019
Date last updated
2/08/2022
Date data sharing statement initially provided
15/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing active participants and guided observers on measures of self efficacy and task load when undertaking simulation education during induction training at Greater Sydney Area Helicopter Emergency Medical Service
Scientific title
Evaluation of self-efficacy and perceived task load in senior clinicians undertaking simulation education at Greater Sydney Area Helicopter Emergency Medical Service induction training: is there comparable benefit between active participants and observers and does this translate to clinical performance?
Secondary ID [1] 297025 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Task load 311005 0
self-efficacy 311006 0
Condition category
Condition code
Emergency medicine 309656 309656 0 0
Resuscitation
Public Health 309679 309679 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Months
Description of intervention(s) / exposure
Active participants in high fidelity simulation exercises that are a routine component of NSW Aeromedical Operations 6-monthly induction training. These exercises are of 45 to 60 minutes duration. They involve the use of actors as patients, or mannakins if procedures are required to be performed; as well as paramedics or paramedic students as ambulance staff. Real-time patient observations (ECG, HR, SBP, ETCO2) are provided to teams through an i-simulate patient monitor. Scenarios include interhospital transport scenarios such as difficult staff interaction, unanticipated airway problems, as well as prehospital exercises such as severe combative head injuries, trapped patients and traumatic cardiac arrest. Participants are expected to behave as they would in real-time (eg no sudden jumps in time or forced urgency)
Intervention code [1] 313305 0
Not applicable
Comparator / control treatment
Directed observers in high fidelity simulation exercises that are a routine component of NSW Aeromedical Operations 6-monthly induction training. The directed observers observe the same scenario as the active participants, The 'directed' obersevation means that observers may be given specific areas of feedback to observe, or questions to answer as the scenario progresses.
Control group
Active

Outcomes
Primary outcome [1] 318624 0
The perceived performance capacity, measured using the NASA-TLX (task load index), of active participants and directed observers
Timepoint [1] 318624 0
immediately following high-fidelity simulation education activities
Primary outcome [2] 318625 0
The perceived performance capacity, measured using the NASA-TLX (task load index), of active participants and directed observers
Timepoint [2] 318625 0
following three months of clinical experience after training is complete.
Secondary outcome [1] 365533 0
Participants’ perceived self-efficacy . This will be measured using a modification of an established self-efficacy questionnaire obtained from the literature on simulation education (Watters C, Reedy G, Ross A, et al. Does interprofessional simulation increase self-efficacy: a comparative study. BMJ Open 2015;5:e005472. doi:10.1136/ bmjopen-2014-005472 )
Timepoint [1] 365533 0
At baseline (the start of GSA-HEMS induction), completion of GSA-HEMS induction and 3 months post completion of induction.

Eligibility
Key inclusion criteria
All consenting students undertaking the GSA-HEMS induction course
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Analysis will be performed using the statistical software package R (R Core Team, Vienna, Austria). Descriptive statistics will be used to describe the dataset. Normally distributed outcomes will be reported as mean plus or minus standard deviation, whilst non-normal data will be reported as median and interquartile range. Categorical data will be reported as counts and proportions. Ninety-five per cent confidence intervals will be constructed around all point estimates.
The self-efficacy questionnaire will be analysed using descriptive statistics only.
The NASA-TLX will be analysed first by converting the participant’s selection to a 100-point scale (1 graduation = 0.5 point). To compare directed observers and active participants at induction, a repeated-measures ANOVA will be used with participant as the within-subjects factor and simulation role (observer/participant) as a between-subjects factors. The comparison of induction course and clinical work by a repeated-measures ANOVA, with participants as the within-subjects factor, and phase (induction / clinical work) as between-subjects factors will be performed. Prior to performing this ANOVA, a missing data analysis will be conducted to check compliance with completing the NASA-TLX

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/02/2019
Actual
11/02/2019
Date of last participant enrolment
Anticipated
5/08/2019
Actual
3/08/2020
Date of last data collection
Anticipated
30/12/2019
Actual
7/11/2020
Sample size
Target
20
Accrual to date
Final
77
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 301595 0
Government body
Name [1] 301595 0
NSW Ambulance Aeromedical Operations
Country [1] 301595 0
Australia
Primary sponsor type
Government body
Name
NSW Ambulance Aeromedical Operations
Address
NSW Aeromedical Operations
33 Nancy Ellis Leebold Drive
Bankstown 2200
NSW
Country
Australia
Secondary sponsor category [1] 301298 0
None
Name [1] 301298 0
Address [1] 301298 0
Country [1] 301298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302323 0
South Eastern Sydney Local Health District Human Research Ethics Committee [EC00136]
Ethics committee address [1] 302323 0
Prince of Wales Hospital
G71 East Wing
Edmund Blacket Building
RANDWICK NSW 2031
Ethics committee country [1] 302323 0
Australia
Date submitted for ethics approval [1] 302323 0
09/11/2018
Approval date [1] 302323 0
04/02/2019
Ethics approval number [1] 302323 0
18/266 (LNR 18/POWH/540)

Summary
Brief summary
High fidelity simulation education (HFSE) is a commonly employed tool within critical care medicine, however, in practice, simulation education is cost and resource intensive This has resulted in the necessary incorporation of observers in HFSE, and increased interest in whether observers can be expected to benefit from this experience, and what factors might increase the benefit of observer participation. Consequently, this study seeks to answer two questions. First, are the experiences in simulation similar for directed observers and active participants? Second, does the HFSE provide a similar experience to clinical work?
We will asses this using two qualitative measuring tools, the NASA Task Load Index and a self efficacy questionnaire, in a repeated measures design with these instruments used in induction and also after a period of clinical work.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89822 0
Dr Jessica Hegedus
Address 89822 0
NSW Aeromedical Operations
33 Nancy Ellis Leebold Drive
Bankstown 2200
NSW
Country 89822 0
Australia
Phone 89822 0
(+61) (0)2 8575 7061
Fax 89822 0
Email 89822 0
[email protected]
Contact person for public queries
Name 89823 0
Matthew Miller
Address 89823 0
NSW Aeromedical Operations
33 Nancy Ellis Leebold Drive
Bankstown 2200
NSW
Country 89823 0
Australia
Phone 89823 0
+61 450329702
Fax 89823 0
Email 89823 0
[email protected]
Contact person for scientific queries
Name 89824 0
Matthew Miller
Address 89824 0
NSW Aeromedical Operations
33 Nancy Ellis Leebold Drive
Bankstown 2200
Country 89824 0
Australia
Phone 89824 0
+61 450329702
Fax 89824 0
Email 89824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
we have not included oit in the ethics and consent process so unable to provide


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.