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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03666468




Registration number
NCT03666468
Ethics application status
Date submitted
14/08/2018
Date registered
11/09/2018
Date last updated
31/07/2019

Titles & IDs
Public title
The Gaming for Medical Education Research (G4MER) Program
Scientific title
Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
Secondary ID [1] 0 0
HC17160-LNR/17/SCHN/194
Universal Trial Number (UTN)
Trial acronym
G4MER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Education, Medical 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - PlayMed
Other interventions - Online Package
Other interventions - Paper Guidelines

Experimental: PlayMed - PlayMed, a highly immersive role-playing computer game
- Focus on Paediatric Asthma and Seizure management

Active Comparator: Online Package (OP) - Online package (OP) of NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management

Placebo Comparator: Paper Guidelines - Paper NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management


Other interventions: PlayMed
A highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management

Other interventions: Online Package
Online package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management

Other interventions: Paper Guidelines
Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Multiple choice quiz score - A paper-based assessment using multiple choice questions designed to test knowledge acquisition for asthma and seizure management. For Studies 1A and 1B, scale 0 to 10, higher is better performance. Studies 2A and 2B, scale from 0 to 15, higher is better.
Timepoint [1] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Primary outcome [2] 0 0
Asthma observed structured clinical examination (OSCE) score - An OSCE administered in a high-fidelity simulation lab. A child with an exacerbation of asthma will be presented and the management required will need to be implemented by the participant. For Studies 1A and 1B, subscale from 0 to 15, higher is better, with scores summed with Outcome 3. Studies 2A and 2B, subscale from 0 to 25, higher is better, with scores summed with Outcome 3.
Timepoint [2] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Primary outcome [3] 0 0
Seizure observed structured clinical examination (OSCE) scoresimulation lab) - An OSCE administered in a high-fidelity simulation lab. A child with a seizure will be presented and the management required will need to be implemented by the participant. For Studies 1A and 1B, subscale from 0 to 15, higher is better, with scores summed with Outcome 3. Studies 2A and 2B, subscale from 0 to 25, higher is better, with scores summed with Outcome 2.
Timepoint [3] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [1] 0 0
Participant attitudes towards educational intervention - Mixed-methods analysis survey. 5-point Likert scale from "Strongly Agree" to "Strongly Disagree".
Timepoint [1] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [2] 0 0
Time to specific actions in OSCE scenarios - E.g. calling for help, oxygen supplementation, salbutamol, anti-epileptic drug
Timepoint [2] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcome [3] 0 0
Anti-epileptic medication(s) administered at correct time during OSCE scenario - E.g. Midazolam or diazepam correctly administered at 5 minutes of seizure activity (yes/no).
Timepoint [3] 0 0
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).

Eligibility
Key inclusion criteria
- Studies 1A and 2A Phase 2 or 3 medical students at UNSW who are enrolled in the
Children's Health Course will be eligible

- Studies 1B and 2B Doctors and nurses employed at Sydney Children's Hospital.
Minimum age
20 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Studies 1A and 2A Medical students not actively enrolled at UNSW

- Studies 1B and 2B Doctors and nurses not actively employed at Sydney Children's
Hospital.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The "G4MER" Program aims to investigate whether serious games add value to medical education
in comparison to an online learning package or clinical practice guidelines. The
investigators will perform a series of investigator-blinded randomised control trials on
doctors, nurses, and medical students at Sydney Children's Hospital. Participants will be
given access to their randomly allocated intervention for 8 weeks or 5 days, and will be
assessed using multiple choice questions (MCQ) and two observed structure clinical
examination (OSCE) stations. Participant attitudes will also be assessed through a
mixed-methods questionnaire.
Trial website
https://clinicaltrials.gov/show/NCT03666468
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael J Coffey, BMed MD
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael J Coffey, BMed MD
Address 0 0
Country 0 0
Phone 0 0
011 61 2 9382 5574
Fax 0 0
Email 0 0
michael.coffey@unsw.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03666468