NCT03666468

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

4.7 years

First QC Date

August 14, 2018

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).

Secondary Outcomes (3)

  • Participant attitudes towards educational intervention

    Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).

  • Time to specific actions in OSCE scenarios

    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

    Post-intervention assessment; 8 weeks (Study 1A and 1B) or 2 hours (Study 2A and 2B).

Study Arms (3)

PlayMed

EXPERIMENTAL

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

Other: PlayMed

Online Package (OP)

ACTIVE COMPARATOR

Online package (OP) of NSW Health Guidelines \- Focus on Paediatric Asthma and Seizure management

Other: Online Package

Paper Guidelines

PLACEBO COMPARATOR

Paper NSW Health Guidelines \- Focus on Paediatric Asthma and Seizure management

Other: Paper Guidelines

Interventions

PlayMedOTHER

A highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management

PlayMed

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

Online Package (OP)

Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management

Paper Guidelines

Eligibility Criteria

Age20 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Children's Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Study Officials

  • Michael J Coffey, BMed MD

    The University of New South Wales

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Coffey, BMed MD

CONTACT

Penelope Uther, MBBS DipPaed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2018

First Posted

September 11, 2018

Study Start

July 3, 2017

Primary Completion

February 28, 2022

Study Completion

April 30, 2022

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations