[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616416":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":40,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":26,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":26,"enrollmentInfo":53,"targetDuration":26,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FibroX-Enabled Care","EXPERIMENTAL","In this arm, primary care providers use FibroX, an AI-powered clinical decision support tool, to assess simulated patient cases for significant liver fibrosis (≥F2) and clinically significant portal hypertension. FibroX displays a risk probability score, a triage band (rule-out, indeterminate, rule-in), and a one-line explainability panel showing which clinical factors most influenced the prediction. Providers use this information to make diagnostic and referral decisions (e.g., order VCTE, refer to hepatology, initiate guideline-based therapy). Each provider reviews 16 cases during this intervention period. The goal is to evaluate FibroX's impact on diagnostic accuracy, provider trust, usability, and workflow efficiency compared to usual care.",[13],"Device: FibroX",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","ACTIVE_COMPARATOR","In this arm, primary care providers assess simulated patient cases using standard clinical tools available in routine practice. These include laboratory results, vital signs, problem lists, medications, and prior imaging. Providers may optionally use the FIB-4 calculator to estimate liver fibrosis risk. Each provider reviews 16 cases during this period. No AI decision support is provided. This arm serves as the comparator to evaluate whether FibroX improves diagnostic accuracy for significant liver fibrosis (≥F2) and clinically significant portal hypertension, as well as provider trust, usability, and workflow efficiency over usual care.",[19],"Other: Usual Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","FibroX","FibroX is an explainable artificial intelligence (AI) tool designed to assist primary care providers in diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). It uses routinely available clinical data (e.g., age, AST, ALT, platelets, BMI, HbA1c, creatinine) to generate a risk probability score, a triage band (rule-out, indeterminate, rule-in), and a one-line explainability panel using Shapley Additive Explanations (SHAP). Providers use FibroX during simulated patient encounters to guide diagnostic and referral decisions (e.g., order VCTE, refer to hepatology, initiate guideline-based therapy). The tool aims to improve diagnostic accuracy, increase provider trust, reduce missed diagnoses, and support guideline-concordant triage in primary care.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"In the usual care condition, primary care providers assess simulated patient cases using standard clinical tools available in routine practice. These include laboratory results, vital signs, problem lists, medications, and prior imaging. Providers may optionally use the FIB-4 calculator to estimate liver fibrosis risk. No AI decision support is provided. This intervention serves as the comparator to evaluate whether FibroX improves diagnostic accuracy for significant liver fibrosis (≥F2) and clinically significant portal hypertension, as well as provider trust, decision-making quality, and workflow efficiency compared to usual care.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Basile Njei, MD, MPH, PhD, FRCP","CONTACT","475-227-5537","basile.njei@yale.edu",{"name":37,"role":33,"phone":38,"phoneExt":26,"email":39},"Ulrick S Kanmounye, MD, MPH, MSc","5705404973","ulricksidney@gmail.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Basile Njei","Associate Director (Bioinformatics), Yale Liver Center","100616416","improving-liver-fibrosis-diagnosis-in-primary-care-using-fibrox-ai-100616416",false,"NCT07305324","Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI","Validation of an AI Tool for Improving MASLD Advanced Liver Fibrosis Diagnosis in Primary Care: A Provider-Level Crossover Randomized Controlled Trial Pilot","Inclusion Criteria:\n\n* Licensed primary care providers (MD, DO, NP, or PA)\n* Currently practicing in adult primary care (≥0.5 Full-Time Equivalent)\n* Affiliated with one of the participating clinics (academic, community, or Federally Qualified Health Center)\n* Willing and able to participate in simulated electronic health record (EHR)-based case reviews\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Providers not actively practicing in adult primary care\n* Providers with less than 0.5 FTE in clinical practice\n* Prior involvement in the development or validation of the FibroX tool\n* Inability to complete both simulation periods due to scheduling or other constraints","ALL","18 Years",{"count":54,"type":55},40,"ESTIMATED","INTERVENTIONAL",[58],"NA","The goal of this clinical trial is to learn whether an artificial intelligence (AI) tool called FibroX can help primary care providers better diagnose significant liver fibrosis (≥F2) and clinically significant portal hypertension in adults with metabolic dysfunction-associated steatotic liver disease (MASLD).\n\nThe main questions it aims to answer are:\n\n* Can FibroX improve the accuracy of diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension compared to usual care?\n* Is FibroX easy to use and acceptable to primary care providers in simulated clinical settings?\n* Do providers trust FibroX as a decision-support tool?\n\nResearchers will compare FibroX-assisted care to usual care to see if FibroX improves diagnostic accuracy, provider trust, and supports better decision-making.\n\nParticipants will:\n\n* Be primary care providers (MDs, DOs, NPs, PAs) from diverse clinics\n* Review simulated patient cases with MASLD risk factors\n* Use either usual care tools (standard labs and optional FIB-4 calculator) or FibroX (AI-generated risk score, triage band, and explainability panel)\n* Make diagnostic and referral decisions for each case\n* Complete surveys on usability, trust in AI, confidence, and cognitive workload\n\nThis study will help determine whether FibroX can be integrated into real-world primary care workflows to support earlier and more accurate detection of liver fibrosis and portal hypertension, potentially reducing missed diagnoses, unnecessary referrals, and improving patient outcomes.",[61,62],"MASLD","Fibrosis of Liver",[64,65,66,67,68,69,70],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Advanced Liver Fibrosis","Primary Care Providers","Explainable AI","Provider-Level Crossover Trial","Simulation-Based Clinical Trial","Pilot Study","NOT_YET_RECRUITING","2025-12-12",{"date":74,"type":75},"2025-12-26","ACTUAL",{"date":77,"type":55},"2026-06-15",{"date":79,"type":55},"2027-06-15",{"name":5,"class":6}]