Status:

RECRUITING

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

Lead Sponsor:

Massachusetts General Hospital

Conditions:

Liver Disease Chronic

End Stage Liver DIsease

Eligibility:

All Genders

18+ years

Phase:

NA

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 li...

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 improvi...

Eligibility Criteria

Inclusion

  • Patient
  • 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

  • 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

Key Trial Info

Start Date :

September 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2027

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05998330

Start Date

September 20 2023

End Date

July 1 2027

Last Update

July 17 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114