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

Mass General Brigham

Status: Enrolling

Conditions: Cirrhosis; Liver Cirrhosis; Liver Disease Chronic; End Stage Liver DIsease

Treatments: Behavioral: Hepatology Home Hospital

Study type: Interventional

Funder types: Other

Identifiers

NCT05205954

2021P002486

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hepatology Hospital at Home

Experimental group

Description:

Patients with advanced liver disease receive hospital-level care in the home setting

Treatment:

Behavioral: Hepatology Home Hospital