Education, MedicalG4MERNCT03666468
The Gaming for Medical Education Research (G4MER) Program
A study testing PlayMed, Online Package and Paper Guidelines in people with Education, Medical, run by The University of New South Wales at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Education, Medical
- What is being tested?
- PlayMed, Online Package and Paper Guidelines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Jul 2017to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Sydney Children's Hospital
Randwick, New South Wales, 2031
Michael J Coffey, 011 61 2 9382 5574, michael.coffey@unsw.edu.au
Penelope Uther, 011 61 2 9382 5560, penelope.uther@health.nsw.edu.au
About this study
Official title: Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
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.
Read the 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.
- Conditions
- Education, Medical
- Being tested
- PlayMed, Online Package, Paper Guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlayMedOther
A highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management
Online PackageOther
Online package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management
Paper GuidelinesOther
Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management
| Study group | Role | What they receive |
|---|---|---|
| PlayMed | Experimental | PlayMed, a highly immersive role-playing computer game
- Focus on Paediatric Asthma and Seizure management Receives: Other: PlayMed |
| Online Package (OP) | Active comparator | Online package (OP) of NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management Receives: Other: Online Package |
| Paper Guidelines | Placebo comparator | Paper NSW Health Guidelines
- Focus on Paediatric Asthma and Seizure management Receives: Other: Paper Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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.
Measured: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
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.
Measured: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Secondary outcomes (3)
Participant attitudes towards educational intervention
Mixed-methods analysis survey. 5-point Likert scale from "Strongly Agree" to "Strongly Disagree".
Measured: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Time to specific actions in OSCE scenarios
E.g. calling for help, oxygen supplementation, salbutamol, anti-epileptic drug
Measured: 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
E.g. Midazolam or diazepam correctly administered at 5 minutes of seizure activity (yes/no).
Measured: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start3 Jul 2017
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Michael Coffey, The University of New South Wales
- Investigators
- Michael J Coffey, BMed MD, Principal investigator, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666468
- Sponsor's protocol ID
- HC17160-LNR/17/SCHN/194
- Acronym
- G4MER
- Status last verified
- Jul 2019
- First submitted
- 14 Aug 2018
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
- ClinicalTrials.gov ID
- NCT03666468
- Acronym / sponsor ID
- G4MER / HC17160-LNR/17/SCHN/194
- Conditions
- Education, Medical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 groups
| Arm | Type | Receives |
|---|---|---|
| PlayMed | Experimental | Other: PlayMedPlayMed, a highly immersive role-playing computer game - Focus on Paediatric Asthma and Seizure management |
| Online Package (OP) | Active comparator | Other: Online PackageOnline package (OP) of NSW Health Guidelines - Focus on Paediatric Asthma and Seizure management |
| Paper Guidelines | Placebo comparator | Other: Paper GuidelinesPaper NSW Health Guidelines - Focus on Paediatric Asthma and Seizure management |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlayMedA highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management | Other | PlayMed |
| Online PackageOnline package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management | Other | Online Package (OP) |
| Paper GuidelinesPaper NSW Health Guideline focused on Paediatric Asthma and Seizure management | Other | Paper Guidelines |
Primary outcome
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.
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.
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.
3 secondary outcomes
Participant attitudes towards educational intervention
Time frame: 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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Education, Medical
Not yet recruitingObservational study
Federated Learning in Renal Tumor Model
Renal Tumors
Not yet recruiting
Generative AI-Assisted Personalized Feedback for Laparoscopic Skill Learning in Medical Undergraduates
Medical Education
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
RecruitingObservational study
Artificial Intelligence for Automated Clinical Data Exploration From Electronic Medical Records (CardioMining-AI)
Artificial Intelligence, Machine Learning
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Coffey, BMed MD principal investigator
The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PlayMed, Online Package and Paper Guidelines in people with Education, Medical, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Coffey, BMed MD (011 61 2 9382 5574, michael.coffey@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multiple choice quiz score (time frame: Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.