Palliative Care for Advanced Liver Disease
(LiverPAL Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must be taking: Diuretics, Encephalopathy medications
Disqualifiers: Liver transplant, Cancer, Hospice, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment LiverPAL for advanced liver disease?
Palliative care has been shown to improve symptoms and end-of-life care for patients with cancer, and it is beneficial in end-stage liver disease, suggesting that similar benefits might be expected for advanced liver disease.
12345Is palliative care safe for people with advanced liver disease?
The research does not provide specific safety data for palliative care in advanced liver disease, but it is generally used to improve quality of life and manage symptoms in serious illnesses.
34567How is the LiverPAL treatment different from other treatments for advanced liver disease?
LiverPAL is unique because it focuses on providing palliative care (care that improves quality of life by reducing symptoms) specifically for patients with advanced liver disease, a group that often lacks access to such care. Unlike standard treatments that primarily address the liver disease itself, LiverPAL aims to improve the overall well-being and comfort of patients by addressing their significant symptom burden.
13489Eligibility Criteria
This trial is for English-speaking patients hospitalized with advanced liver disease, which includes conditions like overt hepatic encephalopathy (needing medication), ascites (requiring water pills or repeated fluid removal procedures), hepatic hydrothorax (needing water pills), variceal bleeding (one or more episodes), and spontaneous bacterial peritonitis.Inclusion Criteria
Ability to comprehend English and can complete questionnaires
I have advanced liver disease and was hospitalized for it in the last 6 months.
Ability to comprehend English
+1 more
Exclusion Criteria
I have had a liver transplant in the past.
Uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder, or other comorbid condition which prohibits the ability to provide informed consent
My liver cancer is more advanced than early stage criteria allow.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive usual hepatology care with or without early palliative care during hospitalization
Up to 6 months
Follow-up
Participants are monitored for quality of life, symptom management, and end-of-life care preferences
Up to 6 months
Long-term Follow-up
Assessment of end-of-life care and caregiver outcomes after patient death
Up to 60 months
Participant Groups
LiverPAL is being tested to see if starting palliative care early for hospitalized patients with serious liver diseases can help improve their quality of life, ease physical symptoms, better their mood, and enhance communication about their illness.
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Hepatology Care with Early Palliative CareExperimental Treatment1 Intervention
Usual hepatology care with early palliative care
Group II: Usual Hepatology CareActive Control1 Intervention
Usual hepatology care
LiverPAL is already approved in United States for the following indications:
🇺🇸 Approved in United States as LiverPAL for:
- Advanced Liver Disease
- End Stage Liver Disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Loading ...
Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Palliative care in cirrhotic patients: Brief summary of recent AASLD guidance. [2022]Palliative care in decompensated cirrhotic patients is a developing concept which should be used in cirrhotic patients during the advanced and terminal stages. Hepatologists and liver transplant teams mostly ignore the patients palliative care issues while intensively dealing with the liver diseases and its complications. This review is a brief summary of the recently published guidance discussing the palliative care, symptom based treatments and end of life with a collaborative and standartized approach which is recommended to all health care workers of cirrhotic patients.
Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]Palliative care (PC) improves the quality of life of patients with advanced cancer. Our aim was to describe PC referral among patients with advanced cancer, and associated outcomes in an academic medical centre.
Outcomes of Palliative Care Consultations for Hospitalized Patients With Liver Disease. [2020]Although palliative care (PC) has been shown to improve symptoms and end-of-life (EOL) care for patients with cancer, data are lacking on the patterns of use and outcomes of PC consultations for hospitalized patients with liver disease.
Randomised clinical trial: palliative long-term abdominal drains vs large-volume paracentesis in refractory ascites due to cirrhosis. [2021]Palliative care remains suboptimal in end-stage liver disease.
A retrospective study on use of palliative care for patients with alcohol related end stage liver disease in United States. [2022]Palliative care (PC) has been shown to be beneficial in end stage liver disease (ESLD), yet the hospitalization data for PC utilization is unknown.
Palliative Care, Patient-Reported Measures, and Outcomes in Hospitalized Patients With Cirrhosis. [2023]Studies of palliative care (PC) in hospitalized patients with cirrhosis have been retrospective, with limited evaluation of patient-reported measures and outcomes.
Identifying palliative care needs in a Portuguese liver unit. [2019]Chronic liver disease is a major worldwide cause of morbidity and mortality. Palliative care policies are not clearly established in chronic liver disease. The NECPAL CCOMS-ICO© (NECesidades PALiativas/Palliative Needs) is a tool to identify palliative care needs, including a section for liver disease.
Emerging Role of Palliative Care in Patients with Advanced Liver Disease. [2021]Advanced liver disease is increasing in mortality and morbidity worldwide, as a result of growing alcohol consumption, obesity, and viral hepatitis infection. Alongside efforts to reduce these factors, it is clear that we must identify the considerable palliative care needs of these patients in order to improve quality of life and reduce symptom burden. Our review focuses on the current state of palliative and end-of-life care for patients with advanced liver disease, the significant associated symptom burden in this disease group, identified level of involvement and potential benefits of specialist palliative care, as well as possible barriers to accessing this care. We demonstrate that although palliative care involvement varies considerably worldwide, there is much opportunity for improvement. Further research is needed to determine new interventions and models of care that may improve access for patients with liver disease, including an expansion of providers comfortable with generalist palliative care.
Emotional experience of people with advanced liver disease: Secondary data analysis. [2021]Patients with advanced liver disease live mainly in the community with treatment of complications provided for in-hospital. The illness trajectory of advanced liver disease is uncertain and most do not have access to end of life care. Gaps in knowledge and understanding of the patient experience of this condition have been identified.