Palliative Care for End Stage Liver Disease

(PAL-LIVER Trial)

Recruiting in Palo Alto (17 mi)

+17 other locations

Overseen by Manisha Verma, MBBS, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: MELD> 30, Life expectancy < 6 months

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are: Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services) Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary). 14 Clinical Centers across US are recruited to participate in this study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Palliative Care for End Stage Liver Disease?

Research suggests that palliative care can improve quality of life and reduce symptoms for patients with advanced liver disease, similar to its benefits in cancer care. Although evidence is limited, early palliative care intervention has been shown to improve symptoms and encourage advance care planning for patients on liver transplant waiting lists. ^{1 2 3 4 5}

Is palliative care safe for people with end-stage liver disease?

Palliative care is generally considered safe for people with end-stage liver disease, as it focuses on improving quality of life and reducing suffering. Studies suggest that it can help manage symptoms and improve end-of-life care planning without significant safety concerns. ^{3 4 6 7 8}

How is palliative care different from other treatments for end-stage liver disease?

Palliative care for end-stage liver disease focuses on improving quality of life by managing symptoms and providing emotional and practical support, rather than trying to cure the disease. Unlike other treatments that may focus on the liver itself, palliative care addresses the overall well-being of the patient and their caregivers. ^{2 4 8 9 10}

Research Team

Manisha Verma, MBBS, MPH

Principal Investigator

Albert Einstein Healthcare Network

Eligibility Criteria

This trial is for patients with new or ongoing complications of End Stage Liver Disease, including liver cancer, regardless of their transplant status. They must have a caregiver willing to participate. It's not for those with a MELD score over 30 or an expected life expectancy under 6 months.

Inclusion Criteria

I have advanced liver disease or liver cancer and have a caregiver willing to participate.

Exclusion Criteria

Your liver disease is so severe (MELD score > 30) that you may not live more than 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive palliative care through either a consultative model or a trained hepatologist-led model, with in-person visits at initial, 1, 2, and 3 months

3 months

4 visits (in-person)

Follow-up

Participants are monitored for changes in quality of life, patient satisfaction, symptom burden, depression severity, and caregiver burden

3 months

Treatment Details

Interventions

• Palliative Care (Behavioural Intervention)

Trial Overview The study compares two ways to provide palliative care: one where patients see a specialist and another where liver doctors are trained in palliative care. The main goal is to see how these approaches affect quality of life after three months using the FACT-Hep scale.

Participant Groups

Group I: Model 1: Consultative Palliative Care Active Control 1 Intervention

Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.

Group II: Model 2: Trained Hepatologist- led PC Active Control 1 Intervention

A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1

Palliative Care is already approved in Canada for the following indications:

Approved in Canada as Palliative Care for:

• Symptom management for various conditions including cancer, neurological disorders, and end-of-life care

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials

65

Recruited

869,000+

Barry Freedman

Albert Einstein Healthcare Network

Chief Executive Officer since 2003

MBA with a focus on healthcare

Dr. Albert Villarin

Albert Einstein Healthcare Network

Chief Medical Officer since 2008

MD from Albert Einstein College of Medicine

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Nakela L. Cook

Patient-Centered Outcomes Research Institute

Chief Executive Officer since 2020

MD, MPH

Harv Feldman

Patient-Centered Outcomes Research Institute

Chief Medical Officer

MD, MSCE

Findings from Research

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]

Specialist palliative care can significantly improve symptoms and facilitate advance care planning for patients on liver transplant waiting lists, but these patients often receive limited palliative care support.

Healthcare professionals, particularly liver physicians, are hesitant to refer patients to palliative care due to concerns about the perceived curative nature of liver transplants and a lack of clarity on referral criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care for Patients with End-Stage Liver Disease on the Liver Transplant Waiting List: An International Systematic Review. Vijeratnam, SS., Candy, B., Craig, R., et al.[2022]

In a feasibility trial involving 36 patients with end-stage liver disease, long-term abdominal drains showed lower hospital resource utilization and costs compared to large-volume paracentesis, suggesting they may be a more efficient option for managing refractory ascites.

While complications like cellulitis and leakage were more common in the long-term drain group (41% vs. 11% in the paracentesis group), the overall safety profile and high questionnaire completion rates indicate that patients found long-term drains acceptable and potentially transformative for their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. Macken, L., Bremner, S., Gage, H., et al.[2021]

Patients evaluated for liver transplantation who received palliative care (PC) were generally younger and had more severe liver disease, as indicated by higher MELD scores and rates of hepatic encephalopathy, compared to those who did not receive PC.

Utilization of PC services was associated with improved end-of-life outcomes, including a significantly lower likelihood of dying in the ICU and a higher likelihood of having advance care planning discussions and family meetings, indicating better quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative Care and End-of-Life Outcomes in Patients Considered for Liver Transplantation: A Single-Center Experience in the US Midwest. Kieffer, SF., Tanaka, T., Ogilvie, AC., et al.[2023]

The Supportive and Palliative Care Indicator Tool (SPICT) demonstrated excellent performance in identifying liver patients who may need specialist palliative care, with a sensitivity of 93% and a positive predictive value of 93% based on a review of 117 medical notes.

The Bristol Prognostic Screening Tool (BPST) also showed good performance for identifying palliative care needs, but both tools had only moderate ability to predict 12-month mortality, indicating they are more effective for referral purposes than for mortality prediction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards? Low, J., Carroll, C., Wilson, J., et al.[2022]

Early integration of palliative care in patients with end-stage liver disease (ESLD) can significantly improve quality of life, reduce anxiety, and enhance satisfaction with care for both patients and caregivers, as supported by recent literature.

Despite its benefits, palliative care is still underutilized in liver disease, highlighting the need for better education among healthcare providers and the development of guidelines to promote its acceptance and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care and end-stage liver disease: a critical review of current knowledge. Rakoski, MO., Volk, ML.[2020]

Palliative care is increasingly recognized as essential for patients with decompensated cirrhosis, particularly during advanced and terminal stages, yet it is often overlooked by hepatologists and liver transplant teams.

Recent guidance emphasizes a collaborative and standardized approach to palliative care, focusing on symptom management and end-of-life issues, which should be adopted by all healthcare workers involved in the care of cirrhotic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care in cirrhotic patients: Brief summary of recent AASLD guidance. Ozdogan, OC.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Palliative Care for Patients with End-Stage Liver Disease on the Liver Transplant Waiting List: An International Systematic Review. [2022]

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

Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. [2021]

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

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

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

Palliative Care and End-of-Life Outcomes in Patients Considered for Liver Transplantation: A Single-Center Experience in the US Midwest. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards? [2022]

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

Palliative care and end-stage liver disease: a critical review of current knowledge. [2020]

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

Palliative care in end-stage liver disease: Time to do better? [2019]

10. Turkey pubmed.ncbi.nlm.nih.gov

Palliative care in cirrhotic patients: Brief summary of recent AASLD guidance. [2022]