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The Gaming for Medical Education Research (G4MER) Program (G4MER)

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666468
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Michael Coffey, The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Education, Medical Other: PlayMed Other: Online Package Other: Paper Guidelines Not Applicable

Detailed Description:

The "G4MER" Program aims to perform a series of randomised control trials on different groups at Sydney Children's Hospital:

  1. 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).
  2. 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).
  3. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 groups
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gaming for Medical Education Research Program: An Investigator-blinded, Randomised Controlled Trial on Serious Games for Doctors, Nurses and Students.
Actual Study Start Date : July 3, 2017
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: PlayMed

PlayMed, a highly immersive role-playing computer game

- Focus on Paediatric Asthma and Seizure management

Other: PlayMed
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

Other: Online Package
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

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  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.


Secondary Outcome Measures :
  1. 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".

  2. 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

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666468


Contacts
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Contact: Michael J Coffey, BMed MD 011 61 2 9382 5574 michael.coffey@unsw.edu.au
Contact: Penelope Uther, MBBS DipPaed 011 61 2 9382 5560 penelope.uther@health.nsw.gov.au

Locations
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Australia, New South Wales
Sydney Children's Hospital Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Michael J Coffey    011 61 2 9382 5574    michael.coffey@unsw.edu.au   
Contact: Penelope Uther    011 61 2 9382 5560    penelope.uther@health.nsw.edu.au   
Sponsors and Collaborators
The University of New South Wales
Investigators
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Principal Investigator: Michael J Coffey, BMed MD The University of New South Wales
  Study Documents (Full-Text)

Documents provided by Dr Michael Coffey, The University of New South Wales:
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Responsible Party: Dr Michael Coffey, Principal Investigator, The University of New South Wales
ClinicalTrials.gov Identifier: NCT03666468    
Other Study ID Numbers: HC17160-LNR/17/SCHN/194
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No