NCT05998330 LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
| NCT ID | NCT05998330 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Liver Disease Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2023-09-20 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Nneka Ufere, MD MSCE
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05998330 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Disease Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05998330 currently recruiting?
Yes, NCT05998330 is actively recruiting participants. Contact the research team at gbizup@mgh.harvard.edu for enrollment information.
Where is the NCT05998330 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05998330 clinical trial?
NCT05998330 is sponsored by Massachusetts General Hospital. The principal investigator is Nneka Ufere, MD MSCE at Massachusetts General Hospital. The trial plans to enroll 200 participants.