Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-05 @ 12:06 AM
Study NCT ID:
NCT06063434
Status:
COMPLETED
Last Update Posted:
2025-10-17
First Post:
2023-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081084', 'term': 'Accidental Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073577', 'term': 'Shift Work Schedule'}], 'ancestors': [{'id': 'D010561', 'term': 'Personnel Staffing and Scheduling'}, {'id': 'D010559', 'term': 'Personnel Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-19', 'size': 137505, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-06T13:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant assignment will be masked within the data with unblinding occurring only after data cleaning has completed.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Physicians will be randomized in a 1:1 fashion to the intervention condition or to the control condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2023-09-20', 'studyFirstSubmitQcDate': '2023-09-26', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Under-triage', 'timeFrame': '1 year', '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'}], 'secondaryOutcomes': [{'measure': 'Mortality and hospital readmission', 'timeFrame': '1 year', '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'}, {'measure': 'Functional dependence', 'timeFrame': '1 year', '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.'}, {'measure': 'Over-triage', 'timeFrame': '1 year', '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heuristics', 'Serious game', 'Guidelines'], 'conditions': ['Trauma Injury', "Physician's Role"]}, 'referencesModule': {'references': [{'pmid': '40465299', 'type': 'DERIVED', 'citation': 'Mohan D, Fischhoff B, Talisa V, Elmer J, White DB, Angus DC, Peitzman A, Bendesky B, Chapman AC, Forsythe RM, Guyette FX, Hynes AM, Oskvarek JJ, Weingart SD, Weinstock M, Chang CH. An Educational Video Game in Trauma Triage at Nontrauma Centers: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2513375. doi: 10.1001/jamanetworkopen.2025.13375.'}, {'pmid': '38365758', 'type': 'DERIVED', 'citation': "Mohan D, Angus DC, Chang CH, Elmer J, Fischhoff B, Rak KJ, Barnes JL, Peitzman AB, White DB. Using a theory-based, customized video game as an educational tool to improve physicians' trauma triage decisions: study protocol for a randomized cluster trial. Trials. 2024 Feb 16;25(1):127. doi: 10.1186/s13063-024-07961-w."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Board certified physicians who work exclusively in the emergency departments (EDs) of non-trauma centers in the US AND triage adult trauma patients\n\nExclusion Criteria:\n\n* non-physician healthcare professionals who work in EDs\n* physicians who work at trauma and non-trauma centers\n* physicians who work outside the continental US'}, 'identificationModule': {'nctId': 'NCT06063434', 'briefTitle': 'Testing the Effectiveness of Night Shift, a Theory-based Customized Video Game', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Testing the Effectiveness of a Theory-based, Customized Video Game at Increasing the Implementation of Clinical Practice Guidelines in Trauma Triage', 'orgStudyIdInfo': {'id': 'STUDY23070156'}, 'secondaryIdInfos': [{'id': 'R01AG076499', 'link': 'https://reporter.nih.gov/quickSearch/R01AG076499', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Night Shift', '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.', 'interventionNames': ['Behavioral: Night Shift']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual education', 'description': 'Participants will receive their usual continuing medical education, but nothing additional.', 'interventionNames': ['Behavioral: Usual education']}], 'interventions': [{'name': 'Night Shift', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Night Shift']}, {'name': 'Usual education', 'type': 'BEHAVIORAL', 'description': 'Standard continuing medical education, including Advanced Trauma Life Support, and the American Board of Emergency Medicine educational modules (e.g., trauma resuscitation).', 'armGroupLabels': ['Usual education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Deepika Mohan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': '6 months after publication of the primary manuscript.', 'ipdSharing': 'YES', '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.', 'accessCriteria': 'We will upload the data to the open ICPSR repository, where other researchers can access it.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Deepika Mohan', 'investigatorAffiliation': 'University of Pittsburgh'}}}}