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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Advanced Cirrhosis, Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis, Cirrhosis, Liver

Intervention / Treatment
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* Behavioral: LiverPAL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Hepatology Care<br>Usual hepatology care | |
| Experimental: Usual Hepatology Care with Early Palliative Care<br>Usual hepatology care with early palliative care | Behavioral: LiverPAL<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks | Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life. | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient FACIT-Pal Score longitudinally between study arms | Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life. | Up to 6 months | 
| Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r) | Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden. | Up to 6 months | 
| Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D) | Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms. | Up to 6 months | 
| Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) | Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. | Up to 6 months | 
| Patient Quality of Life (PROMIS-29+2) | Compare patient quality of life (PROMIS-29+2) scores between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores. | Up to 6 months | 
| Patient End-of-Life (EOL) Care Communication with Caregivers | Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life? | Final assessment prior to patient death or at 6 months | 
| Patient End-of-Life (EOL) Care Communication with Clinicians | Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life? | Final assessment prior to patient death or at 6 months | 
| Documentation of Patient End-of-Life (EOL) Care Preferences | Compare documentation of EOL care preferences in the electronic health record between study arms since baseline. | After patient death, up to 60 months |