Trial Summary
What is the purpose of this trial?This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are:
Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)
Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).
14 Clinical Centers across US are recruited to participate in this study.
Is Palliative Care a promising treatment for End Stage Liver Disease?Yes, Palliative Care is a promising treatment for End Stage Liver Disease because it focuses on improving the quality of life by managing symptoms and providing support to patients and their families. It helps reduce suffering and addresses the significant needs of patients with advanced liver disease.12469
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for palliative care in end-stage liver disease?The available research does not directly address safety data for palliative care in end-stage liver disease. However, studies indicate that palliative care can improve quality of life, reduce ICU admissions, and enhance end-of-life care planning for patients with end-stage liver disease. There is evidence of benefits from early integration of palliative care, but specific safety data is not detailed in the provided studies.267810
What data supports the idea that Palliative Care for End Stage Liver Disease is an effective treatment?The available research shows that palliative care can improve the quality of life for patients with end-stage liver disease by reducing their symptom burden. Although evidence is limited, there is a growing recognition of the need for better care for these patients. Palliative care helps manage symptoms and involves discussions about future care, which can be beneficial. However, there are challenges in providing this care, such as misconceptions about its purpose and lack of resources. Compared to other treatments, palliative care focuses on improving comfort and quality of life, which is crucial for patients with advanced liver disease.34567
Eligibility Criteria
This trial is for patients with new or ongoing complications of End Stage Liver Disease, including liver cancer, regardless of their transplant status. They must have a caregiver willing to participate. It's not for those with a MELD score over 30 or an expected life expectancy under 6 months.Inclusion Criteria
I have advanced liver disease or liver cancer and have a caregiver willing to participate.
Treatment Details
The study compares two ways to provide palliative care: one where patients see a specialist and another where liver doctors are trained in palliative care. The main goal is to see how these approaches affect quality of life after three months using the FACT-Hep scale.
2Treatment groups
Active Control
Group I: Model 1: Consultative Palliative CareActive Control1 Intervention
Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.
Group II: Model 2: Trained Hepatologist- led PCActive Control1 Intervention
A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1
Palliative Care is already approved in European Union, United States, Canada, Australia for the following indications:
🇪🇺 Approved in European Union as Palliative Care for:
- Symptom management for various conditions including cancer, neurological disorders, and end-of-life care
🇺🇸 Approved in United States as Palliative Care for:
- Symptom management for various conditions including cancer, neurological disorders, and end-of-life care
🇨🇦 Approved in Canada as Palliative Care for:
- Symptom management for various conditions including cancer, neurological disorders, and end-of-life care
🇦🇺 Approved in Australia as Palliative Care for:
- Symptom management for various conditions including cancer, neurological disorders, and end-of-life care
Find a clinic near you
Research locations nearbySelect from list below to view details:
VA BostonBoston, MA
VA BronxBronx, NY
Indiana UniversityIndianapolis, IN
University of Michigan Medical CenterAnn Arbor, MI
More Trial Locations
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Who is running the clinical trial?
Albert Einstein Healthcare NetworkLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Palliative care in end-stage liver disease: Time to do better? [2019]Optimal involvement of palliative care (PC) services in the management of patients with decompensated cirrhosis and end-stage liver disease (ESLD) is limited. This may result from both ignorance and the failure to recognize the spectrum and unpredictability of the underlying liver condition. Palliative care is a branch of medicine that focuses on quality of life (QoL) by optimizing symptom management and providing psychosocial, spiritual, and practical support for both patients and their caregivers. Historically, palliative care has been underutilized for patients with decompensated liver disease. This review provides an evidence-based analysis of the benefits of the integration of palliative care into the management of patients with ESLD. Liver Transplantation 24 961-968 2018 AASLD.
Palliative care and end-stage liver disease: a critical review of current knowledge. [2020]End-stage liver disease (ESLD) is associated with high symptom burden, poor quality of life, and significant healthcare costs. Palliative care, which is not synonymous with hospice or end-of-life care, is a multidisciplinary model of care that focuses on patient-centered goals with the intent of improving quality of life and reducing suffering. This review will summarize current literature supporting the benefits of early integration of palliative care in patients in this population.
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.
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.
Palliative care in liver disease: what does good look like? [2023]The mortality rate from chronic liver disease in the UK is rising rapidly, and patients with advanced disease have a symptom burden comparable to or higher than that experienced in other life-limiting illnesses. While evidence is limited, there is growing recognition that care of patients with advanced disease needs to improve. Many factors limit widespread provision of good palliative care to these patients, including the unpredictable trajectory of chronic liver disease, the misconception that palliative care and end-of-life care are synonymous, lack of confidence in prescribing and lack of time and resources. Healthcare professionals managing these patients need to develop the skills to ensure effective delivery of core palliative care, with referral to specialist palliative care services reserved for those with complex needs. Core palliative care is best delivered by the hepatology team in parallel with active disease management. This includes ensuring that discussions about disease trajectory and advance care planning occur alongside active management of disease complications. Liver disease is strongly associated with significant social, psychological and financial hardships for patients and their carers; strategies that involve the wider multidisciplinary team at an early stage in the disease trajectory help ensure proactive management of such issues. This review summarises the evidence supporting palliative care for patients with advanced chronic liver disease, presents examples of current best practice and provides pragmatic suggestions for how palliative and disease-modifying care can be run in parallel, such that patients do not miss opportunities for interventions that improve their quality of life.
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.
Palliative Care for Patients with End-Stage Liver Disease on the Liver Transplant Waiting List: An International Systematic Review. [2022]People with end-stage liver disease on the liver transplant waiting list have high symptom burden, which can successfully be addressed by specialist palliative care. Potential tensions with the perceived curative nature of liver transplant make delivering specialist palliative care challenging. This systematic review seeks to establish what is known on the impact of specialist palliative care for patients on liver transplant waiting lists, healthcare professionals' perspectives of providing specialist palliative care for this population, and uptake of advance care planning (ACP). Medline, Embase, and CINAHL were searched to May 5, 2020. Qualitative and quantitative findings were grouped together according to main relevant themes. Eight studies of mixed quality and mainly quantitative, were identified. Findings suggest early palliative care intervention improve patients' symptoms and prompt ACP conversations, but patients on the waiting list receive limited palliative care input. Liver physicians' lack of clarity on referral criteria and liver transplant patients' concerns of being abandoned, were reasons for reluctance to refer to specialist palliative care. They felt referral to specialist palliative care is appropriate only for patients receiving hospice or end of life care. Uptake and understanding of ACP and goals of care designation by patients is poor. This review found evidence of benefit of specialist palliative care for patients on liver transplant waiting lists, but found in a limited understanding of their role. Evidence is limited to studies from North America. Future research is needed to understand better how palliative care could be provided into this clinical environment.
Do screening tools assess palliative care needs and 12-month mortality in patients admitted to hepatology in-patient wards? [2022]Many liver patients have unmet palliative care needs, but liver clinicians are unclear whom to refer to specialist palliative care (SPC). The Supportive and Palliative Care Indicator Tool (SPICT) and the Bristol Prognostic Screening Tool (BPST) could help identify suitable patients, but neither has been tested for this role. This study evaluated their role as screening tools for palliative care needs and for predicting 12-month mortality.
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 and End-of-Life Outcomes in Patients Considered for Liver Transplantation: A Single-Center Experience in the US Midwest. [2023]Introduction: Previous research has shown limited palliative care (PC) utilization among patients evaluated for liver transplantation (LT) despite the cohort's significant symptom burden, high frequency of hospitalization and risk of rapid decompensation. Our aim was to evaluate patient characteristics and end-of-life (EOL) outcomes (i.e. ICU utilization, code status, advance care planning) associated with the use of PC services in patients who were evaluated for LT. Methods: We performed a single-center cross-sectional study comprised of 223 deceased patients evaluated for LT between 1/1/2017 and 12/31/2021. We evaluated demographic characteristics and EOL outcomes for differences between patients who received PC consultation and those who did not. EOL outcomes associated with PC use were assessed using logistic and linear regression analysis adjusted for patient demographics. Results: Patients who received PC consultation were younger (mean 57 vs. 61; P = 0.048), had higher Model for end-stage Liver Disease (MELD) scores (27.5 vs. 22; P = 0.001), higher rates of hepatic encephalopathy (96% vs. 84%, P = 0.005), and were more frequently declined for LT (77% vs. 57%; P = 0.008). Patients who received PC services were less likely to die in the ICU (OR = 0.07 [0.02-0.18]) and were more likely to have documented advance care planning (OR = 3.16 [1.47-6.97]), family meetings (OR = 6.58 [2.72-17.08]), and goals-of-care discussions (OR = 14.83 [4.39-69.29]). Conclusion: For patients being evaluated for LT, PC utilization differed based on demographics, disease complications and severity, and transplant status. Those who received PC services had higher quality EOL care planning and fewer ICU admissions.