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

NCT05998330 | Recruiting

• 5 other identifiers: 2023P00189480736242379243432236965
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Patient FACIT-Pal Score longitudinally between study arms

  Up to 6 months

• Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)

  Up to 6 months

• Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

  Up to 6 months

• Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)

  Up to 6 months

• Patient End-of-Life (EOL) Care Communication with Clinicians

  Final assessment prior to patient death or at 6 months

Other Outcomes (18)

• Patient End-of-Life (EOL) Care

  Within 30 days of patient death

• Caregiver Quality of Life (PROMIS-29+2)

  Up to 6 months

• Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

  Up to 6 months

Study Arms (2)

Usual Hepatology Care

NO INTERVENTION

Usual hepatology care

Usual Hepatology Care with Early Palliative Care

EXPERIMENTAL

Usual hepatology care with early palliative care

Behavioral: LiverPAL

Interventions

LiverPAL BEHAVIORAL

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.

Usual Hepatology Care with Early Palliative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \. Inability to comprehend English

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

End Stage Liver Disease; Fibrosis; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nneka Ufere, MD MSCE

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grace Bizup, BA

CONTACT

617-724-1316; gbizup@mgh.harvard.edu

William Munroe, BA

CONTACT

617- 726-0161; wlmunroe@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 18, 2023
• Study Start: September 20, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)