Inpatient palliative care for patients with advanced liver disease
LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
This study tests if adding palliative care specialists to the treatment of hospitalized patients with advanced liver disease can improve their quality of life and overall experience.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05998330 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of early integration of palliative care for hospitalized patients suffering from advanced liver disease. It compares standard hepatology care with the addition of palliative care specialists to assess improvements in quality of life, physical symptoms, mood, and communication regarding serious illness. The goal is to determine if palliative care can enhance the overall experience and end-of-life care for these patients and their families.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients diagnosed with advanced liver disease, specifically those with cirrhosis and related complications.
Not a fit: Patients who have undergone liver transplantation or have uncontrolled cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and symptom management for patients with advanced liver disease.
How similar studies have performed: Previous studies have shown that integrating palliative care in various medical settings can improve patient outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Nneka Ufere, MD MSCE — Massachusetts General Hospital
- Study coordinator: Grace Bizup, BA
- Email: gbizup@mgh.harvard.edu
- Phone: 617-724-1316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.