TraumaNCT04516044
Effect of Videogames on Real-life Triage Patterns
An observational study of Trauma and Physician's Role, run by University of Pittsburgh at 1 site in United States.
Trial summary
In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). Read more about this study
- Who is it for?
- Ages 25 to 100 years
- Conditions the study is for
- Trauma, Physician's Role
- What is being tested?
- Video games
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 686 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2016to 1 Dec 2020
- Phase
- Observational
- 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 25 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients older than 65 who presented after a moderate-severe injury to a non-trauma center in the US during 2016-2018.
Who may be able to join
- Participated in two prior clinical trials (Physician)
- ≥65 years old (Patient)
- enrolled in Medicare fee-for-service
- sustained a moderate-severe injury (i.e. ISS [injury severity score] >15) (Patient)
- treated by physician enrolled in prior clinical trials (Patient)
Who cannot join
- Did not participate in two prior clinical trials (Physician)
- <65 years old (Patient)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Long-term Followup of Effects of Customized Videogames on Physician Triage Practices
In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). This study will now assess long-term outcomes for physicians enrolled in those two trials to evaluate the effect of the interventions on triage practices for trauma patients who presented initially to non-trauma centers in the US between December 2016 and November 2018.
- Conditions
- Trauma, Physician's Role
- Being tested
- Video games
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video gamesBehavioural
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Video game | Patients treated by physicians who were randomized to either play an adventure-based video game that used narrative engagement to recalibrate physician heuristics in trauma triage or a puzzle-based video game that used analogical encoding to recalibrate physician heuristics in trauma triage. Receives: Behavioral: Video games | |
| Control | Patients treated by physicians who were randomized either to nothing at all or to a text-based educational program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients triaged to trauma centers
The investigators will use Medicare claims to measure the number of patients, treated by study participants, who present initially to non-trauma centers after a moderate-severe injury and are transferred to a Level I/II trauma center during that episode of care. They will compare triage patterns for patients treated by physicians in the intervention and in the control groups.
Measured: 1 year following the intervention
Secondary outcomes (2)
Number of moderate-severely injured patients who die 30-days after initial evaluation
Patient mortality 30-days after evaluation for a moderate-severe injury by a physician enrolled in the trial, compared among intervention and control groups.
Measured: 1 year following the intervention
Frequency of resources used for patients with moderate-severe injuries treated by participants
Frequency of resources used (e.g. ICU admission, mechanical ventilation, disposition status) after initial presentation for a moderate-severe injury and treatment by a participating physician, compared among intervention and control groups.
Measured: 1 year following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start30 Oct 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Deepika Mohan, University of Pittsburgh
- Investigators
- Deepika Mohan, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516044
- Sponsor's protocol ID
- STUDY20070012
- Other IDs
- DP2LM012339
- Status last verified
- Feb 2021
- First submitted
- 12 Aug 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data is available for sharing, conditional on approval by the University of Pittsburgh Office of Research and Institutional Review Board.
Publications
Mohan D, Farris C, Fischhoff B, Rosengart MR, Angus DC, Yealy DM, Wallace DJ, Barnato AE. Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial. BMJ. 2017 Dec 12;359:j5416. doi: 10.1136/bmj.j5416.
PubMed 29233854Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
PubMed 30150397
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Followup of Effects of Customized Videogames on Physician Triage Practices
- ClinicalTrials.gov ID
- NCT04516044
- Acronym / sponsor ID
- STUDY20070012
- Conditions
- Trauma, Physician's Role
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- 30 Oct 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 17 Aug 2020 (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.
In 2016 and 2017 the investigators conducted two clinical trials in which emergency medicine physicians were randomized either to an intervention (customized, theoretically-based video games) or to a control (nothing or text-based education). This study will now assess long-term outcomes for physicians enrolled in those two trials to evaluate the effect of the interventions on triage practices for trauma patients who presented initially to non-trauma centers in the US between December 2016 and November 2018.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game | – | Behavioral: Video gamesPatients treated by physicians who were randomized to either play an adventure-based video game that used narrative engagement to recalibrate physician heuristics in trauma triage or a puzzle-based video game that used analogical encoding to recalibrate physician heuristics in trauma triage. |
| Control | – | –Patients treated by physicians who were randomized either to nothing at all or to a text-based educational program. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients older than 65 who presented after a moderate-severe injury to a non-trauma center in the US during 2016-2018.
Key inclusion criteria (5 listed)
- Participated in two prior clinical trials (Physician)
- ≥65 years old (Patient)
- enrolled in Medicare fee-for-service
- sustained a moderate-severe injury (i.e. ISS [injury severity score] >15) (Patient)
- treated by physician enrolled in prior clinical trials (Patient)
Key exclusion criteria (2 listed)
- Did not participate in two prior clinical trials (Physician)
- <65 years old (Patient)
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 |
|---|---|---|
| Video gamesSee arm description | Behavioural | Video game |
Primary outcome
Number of patients triaged to trauma centers
Time frame: 1 year following the intervention
The investigators will use Medicare claims to measure the number of patients, treated by study participants, who present initially to non-trauma centers after a moderate-severe injury and are transferred to a Level I/II trauma center during that episode of care. They will compare triage patterns for patients treated by physicians in the intervention and in the control groups.
2 secondary outcomes
Number of moderate-severely injured patients who die 30-days after initial evaluation
Time frame: 1 year following the intervention
Frequency of resources used for patients with moderate-severe injuries treated by participants
Time frame: 1 year following intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 29233854Mohan D, Farris C, Fischhoff B, Rosengart MR, Angus DC, Yealy DM, Wallace DJ, Barnato AE. Efficacy of educational video game versus traditional educational apps at improving physician decision making in trauma triage: randomized controlled trial. BMJ. 2017 Dec 12;359:j5416. doi: 10.1136/bmj.j5416.
- Background: PubMed 30150397Mohan D, Fischhoff B, Angus DC, Rosengart MR, Wallace DJ, Yealy DM, Farris C, Chang CH, Kerti S, Barnato AE. Serious games may improve physician heuristics in trauma triage. Proc Natl Acad Sci U S A. 2018 Sep 11;115(37):9204-9209. doi: 10.1073/pnas.1805450115. Epub 2018 Aug 27.
- Individual participant dataSharing planned: Yes. De-identified data is available for sharing, conditional on approval by the University of Pittsburgh Office of Research and Institutional Review Board.
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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.
Deepika Mohan, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Physician's Role, run by University of Pittsburgh at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 4 Feb 2021. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients triaged to trauma centers (time frame: 1 year following the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516044, which also lists 2 linked publications.
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 4 Feb 2021.