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

Not Applicable

Recruiting

• Conditions: Liver Disease Chronic; Cirrhosis, Liver; End Stage Liver DIsease; Cirrhosis; Advanced Cirrhosis
• Interventions: Behavioral: LiverPAL

• Registration Number: NCT05998330
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-18
• Study Start: 2023-09-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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)

2. Ability to comprehend English

Patient

Exclusion Criteria

1. Prior history of liver transplantation
2. 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
3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
4. Presence of hepatocellular carcinoma beyond Milan criteria
5. Are already receiving hospice care
6. Receive a score of <10 on the Simplified Animal Naming Test

Caregiver Inclusion Criteria

1. Adult caregiver (≥ 18 years of age)
2. 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
3. Ability to comprehend English and can complete questionnaires

Caregiver Exclusion Criteria

1. Inability to comprehend English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Usual Hepatology Care with Early Palliative Care	LiverPAL	Usual hepatology care with early palliative care

Primary Outcome Measures

Name	Time	Method
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks	Up to 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.

Secondary Outcome Measures

Name	Time	Method
Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)	Up to 6 months	Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.
Patient End-of-Life (EOL) Care Communication with Clinicians	Final assessment prior to patient death or at 6 months	"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?"
Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)	Up to 6 months	Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.
Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)	Up to 6 months	Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.
Patient FACIT-Pal Score longitudinally between study arms	Up to 6 months	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.
Documentation of Patient End-of-Life (EOL) Care Preferences	After patient death, up to 60 months	Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States