[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615474":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":34,"responsibleParty":53,"collaborators":12,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":12,"enrollmentInfo":65,"targetDuration":12,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":81,"overallStatus":91,"whyStopped":12,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"MetroWest Artificial Intelligence Research Workgroup","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Care","NO_INTERVENTION","Patients receive usual ICU care per local practice. De-identified admission data may be processed and submitted to the LLM for research purposes, but AI output is not shared with treating clinicians and does not influence real-time management.",null,{"label":14,"type":6,"description":15,"interventionNames":16},"AI-Assisted Care","Patients receive standard ICU care plus point-of-care LLM-based decision support at admission. De-identified admission data are formatted and submitted to an LLM (ChatGPT-5). The model returns a primary diagnosis, ranked differential diagnosis list, suggested additional information, and prioritized therapeutic recommendations. This output is provided to the admitting team for consideration in ongoing management.",[17],"Other: Point-of-care large language model decision support (ChatGPT-5)",[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":12},"Point-of-care large language model decision support (ChatGPT-5)","Use of a large language model (ChatGPT-5) to analyze de-identified ICU admission data (history, physical examination, laboratory results, imaging reports, and other documentation) at the time of admission. The model generates diagnostic and therapeutic recommendations that are shared with clinicians in the AI-assisted arm only.",[14],[24],{"name":25,"affiliation":26,"role":27},"Eric Silverman, M.D.","MetroWest Medical Center and St. Vincent Hospital","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":12,"email":33},"Eric Silverman, M.D. principal Investigator, M.D.","CONTACT","508-344-5680","esilverman@pamw.org",[35],{"facility":36,"status":12,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Framingham Union Hospital\u002FMetroWest Medical Center","Framingham","Massachusetts","01702","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-71.41617,42.27926,{"lat":46,"lon":45},[49,50],{"name":25,"role":31,"phone":32,"phoneExt":12,"email":33},{"name":51,"role":31,"phone":12,"phoneExt":12,"email":52},"Chih-Hsien Wu, M.D.","lisa19950421@gmail.com",{"type":54,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100615474","phase-1-point-of-care-ai-assistance-and-critical-care-outcomes-a-randomized-trial-100615474",false,"NCT07293078","Point-of-Care AI Assistance and Critical Care Outcomes: A Randomized Trial","Prospective Evaluation of a Point-of-Care Artificial Intelligence Model in Critical Care Outcomes","POC-AI-ICU","Inclusion Criteria:\n\n1. Adult patients (≥ 18 years) admitted to the medical intensive care unit (MICU) at participating hospitals.\n2. Direct admissions from the emergency department or transfers from medical wards to the MICU.\n3. Critically ill patients meeting local ICU admission criteria.\n\nExclusion Criteria:\n\n1. Transfers to the MICU from outside hospitals, operating room, or post-anesthesia care unit.\n2. Age \\\u003C 18 years.\n3. Incomplete or missing essential clinical information at admission (e.g., key labs or documentation not yet available).\n4. Primary surgical or cardiac (e.g., STEMI) patients.\n5. Pregnant or postpartum women.\n6. Prisoners.","ALL","18 Years",{"count":66,"type":67},1000,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","This is a prospective, unmasked, randomized, multicenter clinical trial evaluating the impact of point-of-care large language model (LLM)-based decision support on diagnostic accuracy and clinical outcomes in adult medical intensive care unit (MICU) patients.\n\nConsecutive adult ICU admissions at participating community hospitals (initially MetroWest Medical Center and St. Vincent Hospital) will be screened for eligibility. Eligible patients will be randomized 1:1 to standard care or an AI-assisted group. In both arms, initial evaluation and management will follow usual practice. For patients randomized to AI assistance, de-identified admission data (history and physical, labs, imaging reports, and other relevant documentation) will be formatted and submitted to a state-of-the-art LLM (ChatGPT-5) at the time of admission. The AI-generated differential diagnosis and therapeutic recommendations will be provided to the admitting team for consideration. For the standard care arm, LLM output will be generated but not shared with clinicians.\n\nAfter discharge, a masked chart review will determine the \"ground truth\" primary diagnosis and extract outcomes including: Primary Outcome - a composite of medical errors (from time of ICU admission through day 7 of ICU stay, or ICU discharge, whichever comes first); Secondary Outcomes - 90-day mortality, ICU and hospital length of stay, and ventilator-free days.",[74,75,76,77,78,79,80],"Critical Illness","Sepsis","Acute Respiratory Failure (ARF)","Multi-organ Failure","Acute Kidney Injury","Delirium Confusional State","Shock",[82,83,84,85,86,87,88,75,80,89,90],"Critical Care","Intensive Care Unit","Large Language Model","Artificial Intelligence","Diagnostic Accuracy","Clinical Decision Support","Critical Care Outcomes","Acute Respiratory Failure","Multiorgan Failure","NOT_YET_RECRUITING","2025-12-15",{"date":94,"type":95},"2025-12-18","ACTUAL",{"date":97,"type":67},"2026-01-01",{"date":99,"type":67},"2029-06-30",{"name":5,"class":6},1]