[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100495640":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":37,"responsibleParty":104,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":12,"enrollmentInfo":121,"targetDuration":12,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":12,"overallStatus":40,"whyStopped":12,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Indiana University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Patients in the usual care arm will receive standard follow-up care from their usual providers based on recommendations made by inpatient providers at the time of discharge from the hospital.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Transitional Liver Clinic (TLC)","ACTIVE_COMPARATOR","Enrolled patients discharged during the experimental TLC intervention implementation period will receive a phone call from TLC staff within 2 business days of discharge followed by an in-person or video telehealth clinic visit with a hepatology APP within 14 days of discharge. TLC staff will provide additional care based on individual patient needs during the 30-day transitional period.",[18],"Other: Transitional Liver Clinic (TLC)",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"Participants in this intervention receive additional attention from their Hepatology providers in terms of an additional call\u002Ftelemedicine visit and more specific\u002Fadditional attention from their Hepatology APP (advanced practice provider) based on individual patient needs",[14],[24],{"name":25,"affiliation":5,"role":26},"Eric Orman, MD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Jake McCarty, BS","CONTACT","317-278-6305","jacmccar@iu.edu",{"name":34,"role":30,"phone":35,"phoneExt":12,"email":36},"Regina Weber, BS","317-278-3584","reginaw@iu.edu",[38,57,74,89],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Chicago","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-87.65005,41.85003,{"lat":50,"lon":49},[53],{"name":54,"role":30,"phone":55,"phoneExt":12,"email":56},"Michael Charleton, MD","773-702-1234","mcharlton@medicine.bsd.uchicago.edu",{"facility":58,"status":40,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Indiana University Division of Gastroenterolgy and Hepatology","Indianapolis","Indiana","46202",{"type":47,"coordinates":63},[64,65],-86.15804,39.76838,{"lat":65,"lon":64},[68,70,73],{"name":69,"role":30,"phone":35,"phoneExt":12,"email":36},"Regina Weber, BS, RRT",{"name":25,"role":30,"phone":71,"phoneExt":12,"email":72},"317-278-1630","esorman@iu.edu",{"name":25,"role":26,"phone":12,"phoneExt":12,"email":12},{"facility":75,"status":40,"city":76,"state":77,"zip":78,"country":44,"countryCode":45,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"University of Michigan","Ann Arbor","Michigan","48109",{"type":47,"coordinates":80},[81,82],-83.74088,42.27756,{"lat":82,"lon":81},[85],{"name":86,"role":30,"phone":87,"phoneExt":12,"email":88},"Elliott Tapper, MD","734- 936-9250","etapper@umich.edu",{"facility":90,"status":40,"city":91,"state":92,"zip":93,"country":44,"countryCode":45,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Albert Einstein Healthcare Network","Philadelphia","Pennsylvania","19141",{"type":47,"coordinates":95},[96,97],-75.16362,39.95238,{"lat":97,"lon":96},[100],{"name":101,"role":30,"phone":102,"phoneExt":12,"email":103},"Victor Navarro, MD","215-456-8242","navarrov@einstein.edu",{"type":26,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Eric Orman","Associate Professor of Medicine",[108],{"name":109,"class":110},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100495640","a-trial-of-post-discharge-transitional-care-for-patients-with-chronic-liver-disease-100495640",false,"NCT05733832","A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease","A Randomized Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease","TLC","Inclusion Criteria:\n\n1. Male or female age ≥18\n2. Diagnosis of advanced liver disease, defined as either (must meet either a or b)\n\n   1. cirrhosis based on (either i or ii):\n\n      * biopsy\n      * characteristic clinical, laboratory, and imaging findings\n   2. acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as\n\n      * onset of jaundice (serum bilirubin \\>3.0 mg\u002FdL) in prior 8 weeks\n      * consumption of \\>40 (female) or 60 (male) g alcohol\u002Fday for ≥6 months, with \\\u003C60 days abstinence before jaundice onset,\n      * AST\\>50 IU\u002FL, AST\u002FALT\\>1.5, and both values \\\u003C400 IU\u002FL\n      * liver biopsy confirmation in patients with confounding factors\n3. Has at least one of the following complications due to advanced liver disease occurring during hospitalization:\n\n   1. ascites requiring diuretics or paracentesis\n   2. hepatic encephalopathy requiring lactulose or rifaximin\n   3. gastrointestinal bleeding due to portal hypertension\n   4. jaundice\n4. Has planned discharge alive to home or a facility within 72 hours of informed consent\n5. Able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. discharge under hospice\n2. listed for liver transplant with MELD-Na ≥ 35\n3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually\n4. unable to speak or understand English and\u002For Spanish\n5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments\n6. lack of access to a telephone\n7. incarcerated\n8. concurrent enrollment in an interventional research study","ALL","18 Years",{"count":122,"type":123},1000,"ESTIMATED","INTERVENTIONAL",[126],"NA","Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.",[129],"Liver Diseases","2025-10-22",{"date":132,"type":133},"2025-10-24","ACTUAL",{"date":135,"type":133},"2023-09-01",{"date":137,"type":123},"2028-06-30",{"name":5,"class":6},4]