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

Mass General Brigham

Status: Enrolling

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

Treatments: Behavioral: LiverPAL

Study type: Interventional

Funder types: Other

Identifiers

NCT05998330

242379 (Other Grant/Funding Number)

2023P001894

236965 (Other Grant/Funding Number)

243432 (Other Grant/Funding Number)

80736 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Usual Hepatology Care

No Intervention group

Description:

Usual hepatology care

Usual Hepatology Care with Early Palliative Care

Experimental group

Description:

Usual hepatology care with early palliative care

Treatment:

Behavioral: LiverPAL