HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease

• Hepatology Home Hospital (Behavioral): The Hepatology Home Hospital intervention entails the following: patient-reported symptoms and vital signs with appropriate triggers for phone calls and home visits, and regular communication with hepatology clinicians regarding care delivered at home to ensure continuity of care.

Primary outcomes

• Escalation Rate [18 months]: The intervention will be deemed feasible if less than 20% of enrolled patients have escalation of care back to the inpatient (brick-and-mortar) hospital

Secondary outcomes

• Patient Experience [Up to 90 days]: To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital
• Adverse Event Reporting [Up to 90 days]: We will assess rates of adverse events (acute kidney injury, falls, delirium, deep vein thrombosis/pulmonary embolism, escalation of care back to an inpatient hospital setting for at least 1 overnight stay, and death) for patient enrolled in HepHospital
• Acceptability [18 months]: Qualitative acceptability ratings from patients, caregivers, and clinicians obtained via exit individual interviews regarding acceptability (i.e. usefulness, effectiveness, and relevance of the intervention) from patients, family caregivers, and clinicians.

Other outcomes

• Decline Rate [18 months]: We will assess rates that patients decline to enroll in HepHospital
• Quality of life (PROMIS-29 +2) [Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge]: Change in participants' QOL as measured by the PROMIS-29+2 scale throughout the study.
• Change in symptom Burden (Edmonton Symptom Assessment System-revised, ESAS-r) [Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge]: Change in participants' symptom burden as measured by the ESAS-r throughout the study.
• Unplanned readmission(s) after index hospitalization [Day of discharge to 30-days and 90-days post-discharge]: We will assess # of unplanned readmission(s) at 30- and 90-days post-discharge
• Emergency Department Visit(s) after index hospitalization [Day of discharge to 30-days and 90-days post-discharge]: We will assess # of emergency department visit(s) at 30- and 90-days post-discharge
• Total costs of care [18 months]: To assess total costs of the acute care episode

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Adult patients ≥ 18 years old with diagnosis of cirrhosis based on histology, radiology, and/or elastography presenting to the emergency department or inpatient general medicine service
2. Patients must have one of the following:

   1. Ascites (requiring diuretics or serial large volume paracenteses)
   2. Hepatic hydrothorax (requiring diuretics)
   3. Hepatic encephalopathy (requiring medications)

Exclusion Criteria: All existing MGB home hospital criteria apply, with the following taking precedent for this specific condition

1. History of solid organ transplantation
2. On hemodialysis
3. MELD score > 20
4. Score <10 on Simplified Animal Naming Test (S-ANT1)
5. Current admission for hemodynamically significant GI bleeding or alcohol withdrawal
6. Require routine administration of controlled substances
7. Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation

• Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. Ann Intern Med. 2020 Jan 21;172(2):77-85. doi: 10.7326/M19-0600. Epub 2019 Dec 17. PMID 31842232
• Kahn-Boesel O, Mitchell H, Li L, Zhu E, El-Jawahri A, Levine D, Ufere NN. Hospital-Level Care at Home for Patients with Cirrhosis. Dig Dis Sci. 2024 May;69(5):1669-1673. doi: 10.1007/s10620-024-08361-5. Epub 2024 Mar 11. PMID 38466464