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

This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis; Cirrhosis; End Stage Liver DIsease; Liver Disease Chronic
• Intervention / Treatment: Behavioral: Hepatology Home Hospital

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nneka Ufere, MD, MSCE; Phone Number: 617-643-3408; Email: nufere@partners.org
• Study Contact Backup: Name: William Munroe, BA; Email: wlmunroe@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Principal Investigator: Nneka Ufere, MD, MSCE
      • Contact: Grace Bizup, BA; Phone Number: 617-724-1316; Email: gbizup@mgh.harvard.edu
      • Contact: Will Munroe, BA; Phone Number: 617-726-0161; Email: wlmunroe@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepatology Hospital at Home; Patients with advanced liver disease receive hospital-level care in the home setting	Behavioral: Hepatology Home Hospital; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Escalation Rate	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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience	To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital	Up to 90 days
Adverse Event Reporting	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	Up to 90 days
Acceptability	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.	18 months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Hospital at home; Home hospital
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Fibrosis; Liver Diseases; Liver Cirrhosis; End Stage Liver Disease
• Other Study ID Numbers: 2021P002486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No