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Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game

Primary Purpose

Trauma Injury, Physician's Role

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Night Shift
Usual education
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Trauma Injury focused on measuring Heuristics, Serious game, Guidelines

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Night Shift

Usual education

Arm Description

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.

Participants will receive their usual continuing medical education, but nothing additional.

Outcomes

Primary Outcome Measures

Under-triage
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

Secondary Outcome Measures

Mortality and hospital readmission
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
Functional dependence
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.
Over-triage
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

Full Information

First Posted
September 20, 2023
Last Updated
September 26, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06063434
Brief Title
Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game
Official Title
Testing the Effectiveness of a Theory-based, Customized Video Game at Increasing the Implementation of Clinical Practice Guidelines in Trauma Triage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma Injury, Physician's Role
Keywords
Heuristics, Serious game, Guidelines

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Physicians will be randomized in a 1:1 fashion to the intervention condition or to the control condition.
Masking
Outcomes Assessor
Masking Description
Participant assignment will be masked within the data with unblinding occurring only after data cleaning has completed.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Night Shift
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual education
Arm Type
Active Comparator
Arm Description
Participants will receive their usual continuing medical education, but nothing additional.
Intervention Type
Behavioral
Intervention Name(s)
Night Shift
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual education
Intervention Description
Standard continuing medical education, including Advanced Trauma Life Support, and the American Board of Emergency Medicine educational modules (e.g., trauma resuscitation).
Primary Outcome Measure Information:
Title
Under-triage
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mortality and hospital readmission
Description
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
Time Frame
1 year
Title
Functional dependence
Description
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.
Time Frame
1 year
Title
Over-triage
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepika Mohan, MD
Phone
4126470860
Email
mohand@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mary Beth Ryabik, RN
Email
mbryabik12@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepika Mohan, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game

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