NCT05205954

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

December 28, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
3.5 years until next milestone

Study Start

First participant enrolled

July 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

December 28, 2021

Last Update Submit

July 21, 2025

Conditions

CirrhosisEnd Stage Liver DIseaseLiver CirrhosisLiver Disease Chronic

Keywords

Hospital at homeHome hospital

Outcome Measures

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

    18 months

Secondary Outcomes (3)

  • Patient Experience

    Up to 90 days

  • Adverse Event Reporting

    Up to 90 days

  • Acceptability

    18 months

Other Outcomes (6)

  • Decline Rate

    18 months

  • Quality of life (PROMIS-29 +2)

    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)

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

  • +3 more other outcomes

Study Arms (1)

Hepatology Hospital at Home

EXPERIMENTAL

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

Behavioral: Hepatology Home Hospital

Interventions

Hepatology Home HospitalBEHAVIORAL

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.

Hepatology Hospital at Home

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patients must have one of the following:
  • Ascites (requiring diuretics or serial large volume paracenteses)
  • Hepatic hydrothorax (requiring diuretics)
  • Hepatic encephalopathy (requiring medications)

You may not qualify if:

  • History of solid organ transplantation
  • On hemodialysis
  • MELD score \> 20
  • Score \<10 on Simplified Animal Naming Test (S-ANT1)
  • Current admission for hemodynamically significant GI bleeding or alcohol withdrawal
  • Require routine administration of controlled substances
  • Those deemed ineligible based on the MGH Home Hospital, inpatient medicine or hepatology clinician evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31842232BACKGROUND

  • 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.

    PMID: 38466464BACKGROUND

MeSH Terms

Conditions

FibrosisEnd Stage Liver DiseaseLiver Cirrhosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

Nneka Ufere, MD, MSCE

CONTACT

617-643-3408nufere@partners.org

William Munroe, BA

CONTACT

wlmunroe@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 25, 2022

Study Start

July 21, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)