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

RECRUITINGN/ASponsored by Massachusetts General Hospital
Actively Recruiting
PhaseN/A
SponsorMassachusetts General Hospital
Started2023-09-20
Est. completion2027-07
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Advanced CirrhosisCirrhosisCirrhosis, LiverEnd Stage Liver DiseaseLiver DiseaseLiver Disease Chronic

Locations1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114
Grace Bizup, BA617-724-1316gbizup@mgh.harvard.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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