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RecruitingNCT05205954Updated Oct 7, 2026

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

An interventional study of Hepatology Home Hospital in Cirrhosis, End Stage Liver DIsease and Liver Cirrhosis, sponsored by Massachusetts General Hospital. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Cirrhosis
  • End Stage Liver DIsease
  • Liver Cirrhosis
  • Liver Disease Chronic

Keywords

  • Hospital at home
  • Home hospital
03

In context

Fibrosis

3,255 studies on the registry are indexed under Fibrosis; 465 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 2,130 interventional studies indexed under Fibrosis.

Browse Fibrosis studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Hepatology Hospital at Home

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

    Behavioral: Hepatology Home Hospital

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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 18 months

Secondary outcomes

  1. Patient Experience

    To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital

    Time frame: Up to 90 days

  2. 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

    Time frame: Up to 90 days

  3. 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.

    Time frame: 18 months

Other outcomes

  1. Decline Rate

    We will assess rates that patients decline to enroll in HepHospital

    Time frame: 18 months

  2. Quality of life (PROMIS-29 +2)

    Change in participants' QOL as measured by the PROMIS-29+2 scale throughout the study.

    Time frame: Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge

  3. 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.

    Time frame: Baseline to post-discharge (+5 business day window) and 30-days (+10 business day window) post-discharge

  4. Unplanned readmission(s) after index hospitalization

    We will assess # of unplanned readmission(s) at 30- and 90-days post-discharge

    Time frame: Day of discharge to 30-days and 90-days post-discharge

  5. Emergency Department Visit(s) after index hospitalization

    We will assess # of emergency department visit(s) at 30- and 90-days post-discharge

    Time frame: Day of discharge to 30-days and 90-days post-discharge

  6. Total costs of care

    To assess total costs of the acute care episode

    Time frame: 18 months

07

Study locations

2 of 2 sites recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
08

References and documents

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. PubMed 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. PubMed 38466464 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05205954
Lead sponsor
Massachusetts General Hospital
Responsible party
Nneka nnaoke Ufere (Assistant Professor of Medicine, Massachusetts General Hospital) — Principal investigator
First posted
Jan 25, 2022
Start date
Jul 21, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 7, 2026

Study contacts

Nneka Ufere, MD, MSCE
Contact
nufere@partners.org
617-643-3408
William Munroe, BA
Contact
wlmunroe@mgh.harvard.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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