CirrhosisNCT05205954
HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
A study testing Hepatology Home Hospital in people with Cirrhosis and End Stage Liver DIsease, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, End Stage Liver DIsease, Liver Cirrhosis
- What is being tested?
- Hepatology Home Hospital
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Exclusion Criteria: All existing MGB home hospital criteria apply, with the following taking precedent for this specific condition
Show all 13Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
William Munroe, BA contact
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Will Munroe, BA, 617-726-0161, wlmunroe@mgh.harvard.edu
Grace Bizup, BA, 617-724-1316, gbizup@mgh.harvard.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.
- Being tested
- Hepatology Home Hospital
- Keywords
- Hospital at home, Home hospital
- Medical subject headings
- Fibrosis, End Stage Liver Disease, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatology Home HospitalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hepatology Hospital at Home | Experimental | Patients with advanced liver disease receive hospital-level care in the home setting Receives: Behavioral: Hepatology Home Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (3)
Patient Experience
To assess patient experience scores (Picker Patient Experience Questionnaire, Global satisfaction questionnaire) at discharge from HepHospital
Measured: Up to 90 days
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
Measured: Up to 90 days
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start21 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nneka nnaoke Ufere, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205954
- Sponsor's protocol ID
- 2021P002486
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 31842232Kahn-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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HepHospital: A Pilot Trial of a Hepatology Home Hospital Intervention for Patients With Advanced Liver Disease
- ClinicalTrials.gov ID
- NCT05205954
- Acronym / sponsor ID
- 2021P002486
- Keywords
- Hospital at home, Home hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatology Hospital at Home | Experimental | Behavioral: Hepatology Home HospitalPatients with advanced liver disease receive hospital-level care in the home setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- Exclusion Criteria: All existing MGB home hospital criteria apply, with the following taking precedent for this specific condition
- History of solid organ transplantation
- On hemodialysis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatology Home HospitalThe 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. | Behavioural | Hepatology Hospital at Home |
Primary outcome
Escalation Rate
Time frame: 18 months
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
3 secondary outcomes
Patient Experience
Time frame: Up to 90 days
Adverse Event Reporting
Time frame: Up to 90 days
Acceptability
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 31842232Levine 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.
- Background: PubMed 38466464Kahn-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Munroe, BA contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatology Home Hospital in people with Cirrhosis and End Stage Liver DIsease, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nneka Ufere, MD, MSCE (617-643-3408, nufere@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Escalation Rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.