Menu
Recruiting NCT05998330

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

No phase Interventional Liver Disease Chronic End Stage Liver DIsease Cirrhosis Cirrhosis, Liver

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LiverPAL.
Who it may be relevant to
Registry conditions: Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis, Cirrhosis, Liver. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Detailed description

The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).

The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.

Interventions

  • Behavioral LiverPAL
    The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care.

Primary outcome measures

  • Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks [Time frame: Up to 4 weeks]
Secondary outcome measures (6)
  • Patient FACIT-Pal Score longitudinally between study arms [Time frame: Up to 6 months]
  • Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r) [Time frame: Up to 6 months]
  • Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) [Time frame: Up to 6 months]
  • Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) [Time frame: Up to 6 months]
  • Patient End-of-Life (EOL) Care Communication with Clinicians [Time frame: Final assessment prior to patient death or at 6 months]
  • Documentation of Patient End-of-Life (EOL) Care Preferences [Time frame: After patient death, up to 60 months]

Eligibility criteria

Patient Inclusion Criteria:

  • Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:
  • Ascites (requiring diuretics or serial large volume paracenteses)
  • Spontaneous bacterial peritonitis
  • Hepatic hydrothorax (requiring diuretics)
  • Variceal bleed (with one or more occurrences)
  • Overt hepatic encephalopathy (requiring medications)
  • Ability to comprehend English

Patient Exclusion Criteria:

  • Prior history of liver transplantation
  • Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
  • Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
  • Presence of hepatocellular carcinoma beyond Milan criteria
  • Are already receiving hospice care
  • Receive a score of <10 on the Simplified Animal Naming Test

Caregiver Inclusion Criteria

  • Adult caregiver (≥ 18 years of age)
  • A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
  • Ability to comprehend English and can complete questionnaires

Caregiver Exclusion Criteria

1\. Inability to comprehend English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT05998330 · 2023P001894 · 80736 · 242379 · 243432 · 236965

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗