- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063434
Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game
March 6, 2024 updated by: Deepika Mohan, University of Pittsburgh
Testing the Effectiveness of a Theory-based, Customized Video Game at Increasing the Implementation of Clinical Practice Guidelines in Trauma Triage
The goal of this clinical trial is to test the effect of a video game on the implementation of clinical practice guidelines in trauma triage.
The main question it attempts to answer is whether exposure to the game improves compliance with guidelines by emergency medicine physicians working at non-trauma centers in the US.
Participants randomized to the intervention condition will be asked to play a customized, theory-based video game for 2 hours immediately after enrollment, and then return to the game for 20 minutes every three months for the next 9 months.
Participants in the control condition will receive usual care.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Transfer of severely injured patients to trauma centers, either directly from the field or after evaluation at non-trauma centers, reduces preventable morbidity and mortality.
Failure to transfer these patients appropriately (i.e., under-triage) remains common, and occurs in part because physicians at non-trauma centers make diagnostic errors when evaluating the severity of patients' injuries.
The study team developed Night Shift, a theory-based adventure video game, to recalibrate physician heuristics (intuitive judgments) in trauma triage and established its efficacy in the laboratory.
The investigators plan a Type 1 hybrid effectiveness-implementation trial to determine whether the game changes physician triage decisions in real-life, and hypothesize that it will reduce the proportion of patients under-triaged.
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deepika Mohan, MD
- Phone Number: 4126470860
- Email: mohand@upmc.edu
Study Contact Backup
- Name: Mary Beth Ryabik, RN
- Email: mbryabik12@pitt.edu
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Board certified physicians who work exclusively in the emergency departments (EDs) of non-trauma centers in the US AND triage adult trauma patients
Exclusion Criteria:
- non-physician healthcare professionals who work in EDs
- physicians who work at trauma and non-trauma centers
- physicians who work outside the continental US
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Night Shift
Night Shift 2024 is a customized, theory-based adventure video game in which the player takes on the character of Andy Jordan, a young emergency medicine physician who moves home after the disappearance of his grandfather and takes a job at a local community hospital.
The investigators will ask participants to play Night Shift for 2 hours upon enrollment (or within 2 weeks), and then come back to the game quarterly to play it again for 20 minute booster sessions.
They will unlock additional game content each quarter to make the experience more enjoyable.
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The player must not only manage the patients who present to the emergency department of the hospital, gaining experience with the consequences of trauma triage, but also solve the mystery of the grandfather, gaining an emotional connection with the character and making the feedback that "Andy" receives more relevant.
Embedded within Night Shift 2024 is a mini-game (Graveyard Shift) that contains a series of puzzles that reinforce the lessons of the overarching game: transfer severely injured patients expeditiously.
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Active Comparator: Usual education
Participants will receive their usual continuing medical education, but nothing additional.
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Standard continuing medical education, including Advanced Trauma Life Support, and the American Board of Emergency Medicine educational modules (e.g., trauma resuscitation).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Under-triage
Time Frame: 1 year
|
Proportion of severely injured patients, treated by trial participants, not transferred to a higher level of care after initial evaluation at a non-trauma center
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality and hospital readmission
Time Frame: 1 year
|
Proportion of severely injured patients, treated by trial participants, who die or are readmitted to any hospital within 30 days of their initial evaluation at a non-trauma center
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1 year
|
Functional dependence
Time Frame: 1 year
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Proportion of severely injured patients, treated by trial participants, with 90-day preadmission location at home with discharge to a skilled nursing or rehabilitation facility after initial treatment at a non-trauma center.
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1 year
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Over-triage
Time Frame: 1 year
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Proportion of injured patients, treated by trial participants, transferred to a higher level of care after initial evaluation at a non-trauma center with minimal injuries
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deepika Mohan, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2023
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
September 20, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
October 2, 2023
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY23070156
- R01AG076499 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The protocol, primary data, and meta-data (e.g., documentation, protocols used to clean and to manage the data), will be uploaded to the open access Inter-university Consortium for Political and Social Research (open ICPSR) repository at the conclusion of the trial.
Of note, data obtained from Medicare will not be shared as part of the results of the trial, because we do not own those records.
IPD Sharing Time Frame
6 months after publication of the primary manuscript.
IPD Sharing Access Criteria
We will upload the data to the open ICPSR repository, where other researchers can access it.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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