Hepatology home hospital program for people with advanced liver disease

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

This will try a hospital-at-home program that brings hepatology care to adults with cirrhosis who would otherwise need inpatient care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05205954 on ClinicalTrials.gov

What this trial studies

This pilot interventional program offers inpatient-level hepatology care delivered at home by the Massachusetts General Hospital Home Hospital team. Eligible adults with cirrhosis presenting to the emergency department or general medicine service who have ascites, hepatic hydrothorax, or hepatic encephalopathy may be enrolled. Patients with prior solid-organ transplant, on hemodialysis, MELD >20, low cognitive screening (S-ANT1 <10), active hemodynamically significant GI bleed or alcohol withdrawal, or needing routine controlled substances are excluded. The program aims to replace or shorten hospital stays by providing monitoring, treatments, and procedures in the home setting under hospital oversight.

Who should consider this trial

Good fit: Adults (≥18) with cirrhosis who present to the ED or inpatient medicine service and have ascites requiring diuretics or paracentesis, hepatic hydrothorax requiring diuretics, or hepatic encephalopathy requiring medications, with MELD ≤20 and who meet MGH Home Hospital criteria are ideal candidates.

Not a fit: Patients with prior solid-organ transplant, on hemodialysis, MELD >20, very low cognitive screening (S-ANT1 <10), current hemodynamically significant GI bleeding or alcohol withdrawal, those needing routine controlled substances, or judged unsuitable by clinicians are unlikely to benefit from this home-based program.

Why it matters

Potential benefit: If successful, the program could let eligible patients receive hospital-level hepatology care at home, reducing hospital stays and improving comfort and convenience.

How similar studies have performed: Hospital-at-home models have shown positive results for general medical admissions and some chronic conditions, but there is limited published data specifically on home hospital care for advanced liver disease.

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Nneka Ufere, MD, MSCE

Conditions Cirrhosis; End Stage Liver DIsease; Liver Cirrhosis; Liver Disease Chronic; Hospital at home; Home hospital