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

• ClinicalTrials.gov Identifier: NCT06063434
• Recruitment Status: Active, not recruiting
• First Posted: October 2, 2023
• Last Update Posted: March 8, 2024
• Sponsor: University of Pittsburgh
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Deepika Mohan, University of Pittsburgh

Tracking Information

• First Submitted Date: September 20, 2023
• First Posted Date: October 2, 2023
• Last Update Posted Date: March 8, 2024
• Actual Study Start Date: November 27, 2023
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 26, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 26, 2023)

• 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
• Functional dependence [ Time Frame: 1 year ]
  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 [ Time Frame: 1 year ]
  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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Physicians will be randomized in a 1:1 fashion to the intervention condition or to the control condition.

Masking: Single (Outcomes Assessor)
Masking Description:

Participant assignment will be masked within the data with unblinding occurring only after data cleaning has completed.

Primary Purpose: Health Services Research

Condition

• Trauma Injury
• Physician's Role

Intervention

• Behavioral: Night Shift
  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.
• Behavioral: Usual education
  Standard continuing medical education, including Advanced Trauma Life Support, and the American Board of Emergency Medicine educational modules (e.g., trauma resuscitation).

Study Arms

• 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.
  Intervention: Behavioral: Night Shift
• Active Comparator: Usual education
  Participants will receive their usual continuing medical education, but nothing additional.
  Intervention: Behavioral: Usual education

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: September 26, 2023): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06063434
• Other Study ID Numbers: STUDY23070156; R01AG076499 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Analytic Code
• Time Frame: 6 months after publication of the primary manuscript.
• Access Criteria: We will upload the data to the open ICPSR repository, where other researchers can access it.

• Current Responsible Party: Deepika Mohan, University of Pittsburgh
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pittsburgh
• Original Study Sponsor: Same as current
• Collaborators: National Institute on Aging (NIA)

Investigators

• Principal Investigator: Deepika Mohan, MD; University of Pittsburgh

• PRS Account: University of Pittsburgh
• Verification Date: March 2024