RecruitingNot ApplicableNCT05998330

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

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


Sponsor

Massachusetts General Hospital

Enrollment

200 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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
  • 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

Exclusion Criteria7

  • 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
  • \. Inability to comprehend English

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Interventions

BEHAVIORALLiverPAL

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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT05998330


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