Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05998330

LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Led by Massachusetts General Hospital · Updated on 2025-07-17

200

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether adding early palliative care to usual hepatology treatment can improve the quality of life, physical symptoms, mood, and communication about serious illness for hospitalized patients with advanced liver disease, including cirrhosis and related complications. This study compares usual liver disease care alone to usual care combined with early involvement of palliative care specialists. The goal is to see if this approach enhances symptom management and end-of-life care for patients and their families. The study has two groups: one receiving standard hepatology care and the other receiving standard care plus early palliative care. The palliative care team focuses on managing symptoms, supporting coping, improving understanding of illness and prognosis, and coordinating care through hospital stays and transitions. The intervention is behavioral and involves integrating palliative care early during hospitalization. Participants will be assessed for quality of life using the FACIT-Pal tool up to 4 weeks and followed for up to 6 months to monitor symptoms, depression, anxiety, and communication about end-of-life preferences. Researchers will also review documentation of patient care preferences after death for up to 5 years. The study involves regular evaluations during hospitalization and follow-up periods to understand how early palliative care affects patient experiences and outcomes.

CONDITIONS

Brief Title

LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Hospitalized patient with advanced liver disease, including cirrhosis plus one of: ascites requiring diuretics or paracenteses, spontaneous bacterial peritonitis, hepatic hydrothorax requiring diuretics, variceal bleeding, or overt hepatic encephalopathy requiring medications
  • Ability to understand English
  • Adult caregiver (18 years or older) who is a relative or friend identified by the patient, likely to be present during hospitalizations or appointments, or willing to participate by phone
  • Caregiver able to understand English and complete questionnaires
Not Eligible

You will not qualify if you...

  • Prior liver transplantation
  • Uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder, or other conditions preventing informed consent
  • Current or recent history (within 5 years) of extrahepatic cancer treatment, excluding non-melanoma skin cancer
  • Hepatocellular carcinoma beyond Milan criteria
  • Already receiving hospice care
  • Score less than 10 on the Simplified Animal Naming Test
  • Caregiver unable to understand English

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Inpatient Treatment

Duration - Duration of hospitalization

Participants receive usual hepatology care with or without early involvement of palliative care clinicians to manage symptoms, support coping, and coordinate care during their hospital stay.

1 hospitalization period with clinical interactions

Follow-up

Duration - Up to 6 months

Participants are assessed for quality of life, symptom burden, psychological symptoms, and end-of-life care communication for up to 6 months after hospitalization.

Periodic assessments during follow-up

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

G

Grace Bizup, BA

W

William Munroe, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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