Hepatology Home Hospital for Advanced Liver Disease

Overseen By William Munroe, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Controlled substances

Disqualifiers: Hepatic encephalopathy, Dialysis, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 7 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new method of caring for people with serious liver disease by providing hospital-level treatment at home, known as the Hepatology Home Hospital. The goal is to determine if this approach can aid those with conditions like fluid buildup in the belly (ascites), fluid around the lungs (hepatic hydrothorax), or confusion due to liver issues (hepatic encephalopathy). Participants should be adults diagnosed with cirrhosis who require regular treatment for these symptoms. This trial may suit those who frequently end up in the hospital but prefer receiving care at home. As an unphased trial, it offers a unique opportunity to explore innovative care methods that could enhance the quality of life for liver disease patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this healthcare at home intervention is safe for people with advanced liver disease?

Research has shown that home care for people with advanced liver disease can be safe and well-received. One study found that a similar home program was safe for patients with liver failure, suggesting that hospital-level care at home might be effective for some patients.

However, another study found that more than half of the patients required additional care after their home treatment. This indicates that while home care can be safe, patients might still need further medical assistance.

In summary, home care for liver disease appears to be a safe option, but patients should be aware they might still need to visit the hospital. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Hepatology Home Hospital approach because it offers advanced liver disease patients hospital-level care in the comfort of their own homes. Unlike traditional treatments that require lengthy hospital stays, this method aims to deliver comprehensive medical care remotely, potentially reducing complications associated with hospital environments, such as infections. This home-based model can also enhance patient quality of life by allowing them to stay in familiar surroundings while receiving necessary medical attention.

What evidence suggests that the Hepatology Home Hospital program is effective for advanced liver disease?

Research has shown that the Hepatology Home Hospital program, which participants in this trial will receive, can benefit people with advanced liver disease. One study found that many patients required either a follow-up visit at home or a return to the hospital within 30 days of discharge, indicating the program's role in supporting ongoing care. This program also appears promising for delivering complex care at home for patients with cirrhosis, a type of liver disease. Another study noted that patients were more likely to discuss their care goals, emphasizing a focus on personalized treatment plans. While the data is encouraging, it suggests that this approach may help manage advanced liver disease by providing hospital-level care at home. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced liver disease diagnosed through tests or scans, currently hospitalized for swelling in the abdomen due to ascites, and under care at MGH. They must be stable after a day in hospital, have phone or internet access, live within MGH's home service area, and not need intensive care.

Inclusion Criteria

I am 18 or older and have been diagnosed with cirrhosis.

Receiving their outpatient hepatology and/or primary care at MGH

Hemodynamically stable during the first 24 hours of hospital admission

Exclusion Criteria

Require routine administration of controlled substances

Have uncontrolled neuropsychiatric or neurodegenerative illness prohibiting informed consent

I have hepatic encephalopathy and am on medication but don't have a caregiver.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based care for advanced liver disease

7 days

Home visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

Follow-up assessments at 7, 30, and 90 days post-discharge

Long-term follow-up

Participants' health outcomes are monitored for long-term effects

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Hepatology Home Hospital

Trial Overview The study is testing a Hepatology Home Hospital program designed to provide home-based medical care for patients with severe liver conditions. It aims to evaluate if managing these patients at home is effective and safe.

How Is the Trial Designed?

Group I: Hepatology Hospital at Home Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Patients with advanced liver disease often experience intense emotions such as fear, anger, sadness, and guilt, primarily triggered by factors like the shock of diagnosis and uncertainty about their illness.

Understanding these emotional responses is crucial for healthcare providers to offer holistic and supportive care, aligning with a palliative approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emotional experience of people with advanced liver disease: Secondary data analysis. Gray-Renfrew, A., Kimbell, B., Finucane, A.[2021]

In a study of 44,933 hospitalized patients, those with liver disease were younger and had a higher in-hospital mortality rate (28%) compared to cancer patients (16.8%), highlighting the severity of liver disease in hospital settings.

Patients with liver disease were more likely to receive palliative care consultations focused on goals of care (81.7%) rather than pain management (10.9%), yet both groups showed similar improvements in symptoms and changes in resuscitation preferences after consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. Ufere, NN., O'Riordan, DL., Bischoff, KE., et al.[2020]

Nurse-assisted follow-up care for patients with decompensated liver cirrhosis has shown potential benefits in improving health outcomes, including reduced mortality and readmission rates, based on a review of 16 studies involving 1224 participants.

Despite the observed improvements, the studies varied in quality and design, and there is currently no consensus on the most effective type of nurse-assisted intervention, highlighting the need for more rigorous, standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. O'Connell, MB., Bendtsen, F., Nørholm, V., et al.[2023]

Patients with advanced liver disease experience significant symptom burden and have considerable palliative care needs, highlighting the importance of improving their quality of life.

There is a global variability in the involvement of palliative care for these patients, indicating a need for further research and development of new care models to enhance access to specialist palliative services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. Jordan, RI., Tandon, P.[2021]

The rising mortality rate from chronic liver disease in the UK highlights the urgent need for improved palliative care, as patients experience significant symptoms comparable to other life-limiting illnesses.

Effective palliative care should be integrated with active disease management by the hepatology team, ensuring that discussions about disease progression and advance care planning occur alongside treatment, while also addressing the social and psychological challenges faced by patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in liver disease: what does good look like? Woodland, H., Hudson, B., Forbes, K., et al.[2023]

Citations

1. fg.bmj.com fg.bmj.com/content/early/2025/09/26/flgastro-2025-103283

Hepatology at home: a novel pathway for the integrated ... Within 30 days of discharge, 58.7% required a further Hepatology at home encounter or inpatient admission. The 30-day mortality rate was 32.5%.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05205954

HepHospital: A Pilot Trial of a Hepatology Home Hospital ... Study Overview. This research study is evaluating a program that entails a healthcare at home intervention for people with advanced liver disease.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38466464/

Hospital-Level Care at Home for Patients with Cirrhosis In this two-site study, HH was feasible for patients with cirrhosis, holding promise as a hepatology delivery model.

4. withpower.com withpower.com/trial/phase-cirrhosis-of-the-liver-4-2022-02296

Hepatology Home Hospital for Advanced Liver Disease Patients with liver disease were more likely to receive palliative care consultations focused on goals of care (81.7%) rather than pain management (10.9%), yet ...

5. journals.lww.com journals.lww.com/hep/fulltext/2025/01000/innovations_in_health_care_delivery_for_patients.5.aspx

Innovations in health care delivery for patients with cirrhosis In this issue of Hepatology, Dr Wigg and colleagues report on a randomized multicenter trial of a chronic disease management intervention for decompensated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9444080/

A home-based, multidisciplinary liver optimisation ... For the hepatic decompensation cohort, the primary outcome is 30-day re-admission. Secondary outcomes assess changes in liver disease severity ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10363198/

Quantifying Days at Home in Patients with Cirrhosis Inpatient days increased from 4.1 days [95CI = 4.0 to 4.2] for patients with compensated cirrhosis to 13.8 days [95CI = 13.5 to 14.0] for patients with hepatic ...

8. medicine.yale.edu medicine.yale.edu/news-article/liver-home-a-multidisciplinary-program-for-patients-with-advanced-liver-disease/

'Liver Home' – A Multidisciplinary Program for Patients with ... Introducing a new outpatient program for individuals with advanced liver disease who are not eligible for organ transplant.