NCT04516044

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
686

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 30, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2.1 years

First QC Date

August 12, 2020

Last Update Submit

February 3, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year following the intervention

Secondary Outcomes (2)

  • Number of moderate-severely injured patients who die 30-days after initial evaluation

    1 year following the intervention

  • Frequency of resources used for patients with moderate-severe injuries treated by participants

    1 year following intervention

Study Arms (2)

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.

Behavioral: Video games

Control

Patients treated by physicians who were randomized either to nothing at all or to a text-based educational program.

Interventions

Video gamesBEHAVIORAL

See arm description

Video game

Eligibility Criteria

Age25 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 65 who presented after a moderate-severe injury to a non-trauma center in the US during 2016-2018.

You may qualify if:

  • 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)

You may not qualify if:

  • Did not participate in two prior clinical trials (Physician)
  • \<65 years old (Patient)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 29233854BACKGROUND
  • Mohan 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.

    PMID: 30150397BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Deepika Mohan, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Critical Care Medicine

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 17, 2020

Study Start

October 30, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

De-identified data is available for sharing, conditional on approval by the University of Pittsburgh Office of Research and Institutional Review Board.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
3 years
Access Criteria
Contact the PI

Locations