[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656633":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":56,"overallOfficials":66,"centralContacts":70,"locations":76,"responsibleParty":167,"collaborators":169,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":11,"eligibilityCriteria":179,"healthyVolunteers":175,"sex":180,"minAge":181,"maxAge":11,"enrollmentInfo":182,"targetDuration":11,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":192,"overallStatus":207,"whyStopped":11,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},{"fullName":5,"class":6},"University of Michigan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"The proportion of eligible emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.",null,"Initial Emergency Department Visit (approximately 24 hours)",[14,16,19,21,24,27,31,33],{"measure":15,"description":11,"timeFrame":12},"Proportion of eligible ED patients with suspected TBI who receive brain CT imaging and have a clinically significant traumatic lesion.",{"measure":17,"description":11,"timeFrame":18},"Incidence of clinically significant missed traumatic intracranial injury diagnosed within 7 days of the index ED visit","Within 7 days of the index\u002Finitial ED visit",{"measure":20,"description":11,"timeFrame":18},"Incidence of neurosurgical interventions within 7 days of the index ED visit, without a new traumatic event.",{"measure":22,"description":23,"timeFrame":12},"ED length of stay","This will be measured in minutes.",{"measure":25,"description":11,"timeFrame":26},"Initial and sustained provider adherence at 6 and 24 months post-implementation","6 and 24 months post-implementation",{"measure":28,"description":29,"timeFrame":30},"Provider acceptability and feedback","Providers will answer 17 questions regarding the implementation of the biomarker-guided algorithm and acceptability. Information from this will be summarized.","During implementation phase (months 9-32)",{"measure":32,"description":11,"timeFrame":30},"Provider trust in biomarker-guided CT decision making as measured by the proportion of biomarker-negative patients who don't get a CT",{"measure":34,"description":11,"timeFrame":35},"30-day ED revisits and hospitalizations","30 days following Initial Emergency Department Visit",{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","SEQUENTIAL","We will use a complete stepped-wedge cluster-randomized design with 4 time periods (including the baseline), each 6 months long, and 3 steps (with 2 clusters switching from control to treatment at each step). Sites, not patients, will be randomized. No patients will be consented for this study.","HEALTH_SERVICES_RESEARCH",{"masking":42,"maskingDescription":11,"whoMasked":11},"NONE",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Clinical Pathway 2: Clinical Guidelines Only","ACTIVE_COMPARATOR","Clinical Guidelines Only (Canadian CT Head Rule)",[49],"Diagnostic Test: Clinical guidelines only",{"label":51,"type":52,"description":53,"interventionNames":54},"Clinical Pathway 1: Guidelines + Biomarkers","EXPERIMENTAL","Canadian CT Head Rule plus whole blood Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-Terminal Hydrolase L1 (UCH-L1) measurement using the i-STAT.",[55],"Diagnostic Test: Clinical pathway 1: Guidelines plus biomarkers",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DIAGNOSTIC_TEST","Clinical pathway 1: Guidelines plus biomarkers","Patients will be managed using an algorithm that integrates the Canadian CT Head Rule (CCHR) with i-STAT whole-blood GFAP and UCH-L1 testing. Patients who meet CCHR criteria for CT imaging and those whose CT imaging decision-making is not covered by CCHR (e.g., no loss of consciousness or amnesia) will receive i-STAT testing. Sites will be assigned to one of three implementation waves, with two sites transitioning to the Guidelines + Biomarkers phase every six months. Prior to their assigned transition, sites will continue to use guidelines alone. Once a site transitions to the Guidelines + Biomarkers phase, the integrated biomarker-guided algorithm will become the standard-of-care protocol at that site for eligible patients and will remain the standard of care for the remainder of the study.",[51],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":11},"Clinical guidelines only","During the baseline phase, sites will rely solely on established clinical guidelines to guide brain CT utilization in patients with suspected TBI. Specifically, providers will apply the Canadian CT Head Rule, a validated decision instrument that identifies patients at high risk for clinically important brain injury who require CT imaging. All sites will begin in this Guidelines-Only baseline phase and will continue using this approach until their assigned transition to the Guidelines + Biomarkers phase. Sites will transition in three waves, with two sites transitioning every six months.",[45],[67],{"name":68,"affiliation":5,"role":69},"Frederick Korley, MD, PhD","PRINCIPAL_INVESTIGATOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":11,"email":75},"Devon Newman, MS","CONTACT","734-652-9679","devonn@med.umich.edu",[77,96,112,129,141,158],{"facility":78,"status":11,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"UCLA-Olive View Medical Center","Sylmar","California","91342","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-118.44925,34.30778,{"lat":88,"lon":87},[91,94],{"name":92,"role":73,"phone":11,"phoneExt":11,"email":93},"Yesenia Perez","YPerez@dhs.lacounty.gov",{"name":95,"role":69,"phone":11,"phoneExt":11,"email":11},"Breena Taira, MD, MPH",{"facility":97,"status":11,"city":98,"state":80,"zip":99,"country":82,"countryCode":83,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Harbor-UCLA Medical Center","Torrance","90502",{"type":85,"coordinates":101},[102,103],-118.34063,33.83585,{"lat":103,"lon":102},[106,110],{"name":107,"role":73,"phone":108,"phoneExt":11,"email":109},"Evelyn Santana","424-306-5400","evelyn.santana@lundquist.org",{"name":111,"role":69,"phone":11,"phoneExt":11,"email":11},"Kabir Yadav, MD, MS, MHSH",{"facility":113,"status":11,"city":114,"state":115,"zip":116,"country":82,"countryCode":83,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Henry Ford Macomb (HFM)","Clinton Township","Michigan","48038",{"type":85,"coordinates":118},[119,120],-82.91992,42.58698,{"lat":120,"lon":119},[123,127],{"name":124,"role":73,"phone":125,"phoneExt":11,"email":126},"Jo-Ann Rammal","313-404-9110","JRammal1@hfhs.org",{"name":128,"role":69,"phone":11,"phoneExt":11,"email":11},"Joseph Miller, MD, MS",{"facility":130,"status":11,"city":131,"state":115,"zip":132,"country":82,"countryCode":83,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Henry Ford Hospital (HFH)","Detroit","48202",{"type":85,"coordinates":134},[135,136],-83.04575,42.33143,{"lat":136,"lon":135},[139,140],{"name":124,"role":73,"phone":125,"phoneExt":11,"email":126},{"name":128,"role":69,"phone":11,"phoneExt":11,"email":11},{"facility":142,"status":11,"city":143,"state":144,"zip":145,"country":82,"countryCode":83,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Adventist Health Portland (AHP)","Portland","Oregon","97216",{"type":85,"coordinates":147},[148,149],-122.67621,45.52345,{"lat":149,"lon":148},[152,156],{"name":153,"role":73,"phone":154,"phoneExt":11,"email":155},"Maja Strusinska-Thayer","503-418-2713","strusins@ohsu.edu",{"name":157,"role":69,"phone":11,"phoneExt":11,"email":11},"Bory Kea, MD, MCR",{"facility":159,"status":11,"city":143,"state":144,"zip":160,"country":82,"countryCode":83,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Oregon Health & Science University (OHSU)","97239",{"type":85,"coordinates":162},[148,149],{"lat":149,"lon":148},[165,166],{"name":153,"role":73,"phone":154,"phoneExt":11,"email":155},{"name":157,"role":69,"phone":11,"phoneExt":11,"email":11},{"type":69,"investigatorFullName":68,"investigatorTitle":168,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Professor and Executive Vice Chair",[170],{"name":171,"class":172},"United States Department of Defense","FED","100656633","the-pioneer-comparative-effectiveness-study---project-2-100656633",false,"NCT07829107","The PIONEER Comparative Effectiveness Study - Project 2","Comparing the Effectiveness of a Biomarker-plus-clinical Guidelines Algorithm Versus Clinical Guidelines Only for Safely Decreasing Brain Computed Tomography Utilization During Brain Injury Evaluations: The PIONEER Comparative Effectiveness Study","Inclusion\n\n* Age ≥18 years at the time of the emergency department visit.\n* Presentation to a participating emergency department following a traumatic injury mechanism (motor vehicle collision, fall from height, assault, head injury\u002Fhead trauma\u002Fhead strike, struck by or against an object, facial injury or laceration, or other general trauma). Presentations may also include alcohol intoxication or syncope when associated with a suspected traumatic brain injury.\n* Evidence of potential head or brain injury, defined as (i) the head being struck by an object, (ii) the head striking a hard object or surface, (iii) exposure of the brain to significant acceleration\u002Fdeceleration forces, or (iv) clinician documentation that the patient was evaluated for suspected traumatic brain injury.\n* Glasgow Coma Scale (GCS) score of 13-15 at presentation.\n* Presentation to the emergency department within 24 hours of injury.\n\nExclusion Criteria:\n\n* Planned computed tomography (CT) imaging of the maxillofacial bones, chest, abdomen, or pelvis during the ED encounter AND clinicians do not intend to avoid brain CT imaging even if the biomarker test is negative.\n* Current use of anticoagulant or antiplatelet therapy, including but not limited to: Warfarin, Factor Xa inhibitors (e.g., apixaban \\[Eliquis\\], rivaroxaban \\[Xarelto\\]), Clopidogrel, Ticagrelor.\n* Presentation \\>24 hours after injury, due to the declining diagnostic sensitivity of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1) beyond this time window.","ALL","18 Years",{"count":183,"type":184},3000,"ESTIMATED","INTERVENTIONAL",[187],"NA","This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.",[190,191],"Head Injury Trauma","Traumatic Brain Injury, Mild",[193,194,195,196,197,198,199,200,201,202,203,204,205,206],"Emergency department","Struck by or against an object","traumatic brain injury","TBI","CT imaging","head CT","brain CT","biomarkers","clinical decision rule","implementation study","gfap","UCH-L1","glial fibrillary acidic protein","Ubiquitin Carboxy-terminal hydrolase L1","NOT_YET_RECRUITING","2026-09-17",{"date":210,"type":211},"2026-09-22","ACTUAL",{"date":213,"type":184},"2026-10-01",{"date":215,"type":184},"2029-01",{"name":5,"class":6},6]