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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05205954
Enrollment
30
Registered
2022-01-25
Start date
2025-07-21
Completion date
2026-12-31
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, End Stage Liver DIsease, Liver Cirrhosis, Liver Disease Chronic

Keywords

Hospital at home, Home hospital

Brief summary

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

Interventions

BEHAVIORALHepatology 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Escalation Rate18 monthsThe 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

MeasureTime frameDescription
Patient ExperienceUp to 90 daysTo assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital
Adverse Event ReportingUp to 90 daysWe 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
Acceptability18 monthsQualitative 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

MeasureTime frameDescription
Emergency Department Visit(s) after index hospitalizationDay of discharge to 30-days and 90-days post-dischargeWe will assess # of emergency department visit(s) at 30- and 90-days post-discharge
Decline Rate18 monthsWe will assess rates that patients decline to enroll in HepHospital
Total costs of care18 monthsTo assess total costs of the acute care episode
Quality of life (PROMIS-29 +2)Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-dischargeChange 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-dischargeChange in participants' symptom burden as measured by the ESAS-r throughout the study.
Unplanned readmission(s) after index hospitalizationDay of discharge to 30-days and 90-days post-dischargeWe will assess # of unplanned readmission(s) at 30- and 90-days post-discharge

Countries

United States

Contacts

Primary ContactNneka Ufere, MD, MSCE
nufere@partners.org617-643-3408
Backup ContactWilliam Munroe, BA
wlmunroe@mgh.harvard.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026