Hepatology Home Hospital for Advanced Liver Disease

Overseen By Enya Zhu

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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Hepatology Home Hospital for Advanced Liver Disease?

The research suggests that home-based care, like the Hepatology Home Hospital, can be effective for liver disease patients by reducing hospital stays and improving quality of life, as seen in liver transplant patients. Additionally, a similar home-based program for liver failure patients showed it was safe and well-received, indicating potential benefits for advanced liver disease care. ^{1 2 3 4 5}

How is the Hepatology Home Hospital treatment different from other treatments for advanced liver disease?

The Hepatology Home Hospital treatment is unique because it focuses on providing care for advanced liver disease patients in their own homes, rather than in a hospital setting, which can improve access to care and quality of life by integrating palliative care with active disease management. ^{2 6 7 8 9}

What is the purpose of this trial?

This research study is evaluating a program that entails home-based care for people with advanced liver disease.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Hepatology Hospital at Home Experimental Treatment 1 Intervention

Patients with cirrhosis presenting with symptomatic ascites receive their care in the home.

Group II: Usual Hepatology Care Active Control 1 Intervention

Patients with cirrhosis presenting with symptomatic ascites receive their care in the hospital, as usual.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

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]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Liver transplantation. Nursing in hospital-based home care]. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Emotional experience of people with advanced liver disease: Secondary data analysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. [2020]

4. England pubmed.ncbi.nlm.nih.gov

A home-based, multidisciplinary liver optimisation programme for the first 28 days after an admission for acute-on-chronic liver failure (LivR well): a study protocol for a randomised controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Nurse-assisted and multidisciplinary outpatient follow-up among patients with decompensated liver cirrhosis: A systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Creating Effective Models for Delivering Palliative Care in Advanced Liver Disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Emerging Role of Palliative Care in Patients with Advanced Liver Disease. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Palliative care in liver disease: what does good look like? [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

Improving palliative and supportive care in advanced cirrhosis: the HepatoCare model of integrated collaborative care. [2023]