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

NCT ID: NCT05998330

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2027-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Hepatology Care

Usual hepatology care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual Hepatology Care with Early Palliative Care

Usual hepatology care with early palliative care

Group Type: EXPERIMENTAL

LiverPAL

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

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

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

1. Inability to comprehend English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nneka nnaoke Ufere

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nneka Ufere, MD MSCE

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Grace Bizup, BA

Role: CONTACT

gbizup@mgh.harvard.edu

617-724-1316

William Munroe, BA

Role: CONTACT

wlmunroe@mgh.harvard.edu

617- 726-0161

Facility Contacts

Grace Bizup, BA

Role: primary

gbizup@mgh.harvard.edu

617-724-1316

Will Munroe, BA

Role: backup

wlmunroe@mgh.harvard.edu

617- 726-0161

Other Identifiers

80736

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

242379

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

243432

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

236965

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023P001894

Identifier Type: -

Identifier Source: org_study_id