- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666468
The Gaming for Medical Education Research (G4MER) Program (G4MER)
Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The "G4MER" Program aims to perform a series of randomised control trials on different groups at Sydney Children's Hospital:
- Study 1A (Formerly titled "Serious Games in Medical Education - a Randomised Control Trial") is already underway and involves Phase 3 medical students at UNSW having 8 weeks access to the game, an Online Package (OP) or NSW State Guidelines on Asthma and Seizure management. Students are then assessed using multiple choice questions (MCQ) and two observed structure clinical examination (OSCE) stations (detailed below).
- Study 1B is also a randomised control trial similar in design to Study 1A, however it will involve doctors and nurses employed at Sydney Children's Hospital. PlayMed will be compared against the HETI Learning Path Paediatric Clinical Practice Guidelines (Online Package for staff).
- Studies 2A and 2B are identical to Studies 1A and 1B respectively except participants will have 2 hours access to their educational tool. Participants will then immediately undergo the same assessment using multiple choice questions (MCQ) and two observed structure clinical examination (OSCE) stations The proposed study designs are all blinded randomised control trials. Participants may only be involved in Study 1 or Study 2, not both.
Administration
Studies 1A and 1B Participants allocated to the game and to the OP will be given the appropriate access for 8 weeks (instructions provided in the study envelope). Participants allocated to the guidelines will receive a print-out of the guidelines. Participants will be encouraged to engage with their additional educational tool as often as they wish during their eight weeks. In the 8th last week participants will have their knowledge and clinical performance assessed as outlined below.
Studies 2A and 2B Participants allocated to the game, OP and guidelines will be given 2 hours to utilise their assigned teaching tool. Two hours was selected as an appropriate time-frame in which participants would be able complete all cases of the game or online package, or read through the guidelines. Furthermore, it was chosen as it is more pragmatic and better at assessing short-term retention. Computers will be provided for participants to access the game and OP. The guidelines will be printed for participants to read. Participants will then immediately have their knowledge and clinical performance assess as outlined below.
Assessment
Studies 1A, 1B, 2A and 2B Participants will be assessed for knowledge acquisition and clinical performance. Participant knowledge will be assessed using 10 multiple choice questions (MCQ). Participant clinical skills will be assessed via an observed structured clinical examination (OSCE) administered in the simulation laboratory (immediately after the knowledge test); participants will be tested across two clinical scenarios. Strict marking criteria will be used to ensure standardisation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New South Wales
-
Randwick, New South Wales, Australia, 2031
- Recruiting
- Sydney Children's Hospital
-
Contact:
- Michael J Coffey
- Phone Number: 011 61 2 9382 5574
- Email: michael.coffey@unsw.edu.au
-
Contact:
- Penelope Uther
- Phone Number: 011 61 2 9382 5560
- Email: penelope.uther@health.nsw.edu.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PlayMed
PlayMed, a highly immersive role-playing computer game - Focus on Paediatric Asthma and Seizure management |
A highly immersive role-playing computer game focused 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 |
Online package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management
|
|
Placebo Comparator: Paper Guidelines
Paper NSW Health Guidelines - Focus on Paediatric Asthma and Seizure management |
Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multiple choice quiz score
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
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.
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
|
Asthma observed structured clinical examination (OSCE) score
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
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.
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
|
Seizure observed structured clinical examination (OSCE) scoresimulation lab)
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
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.
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant attitudes towards educational intervention
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
Mixed-methods analysis survey.
5-point Likert scale from "Strongly Agree" to "Strongly Disagree".
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
|
Time to specific actions in OSCE scenarios
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
E.g. calling for help, oxygen supplementation, salbutamol, anti-epileptic drug
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
|
Anti-epileptic medication(s) administered at correct time during OSCE scenario
Time Frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
E.g.
Midazolam or diazepam correctly administered at 5 minutes of seizure activity (yes/no).
|
Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael J Coffey, BMed MD, The University of New South Wales
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HC17160-LNR/17/SCHN/194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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