Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
Completed · Not applicable
Conditions studied: End Stage Liver Disease, Decompensated Cirrhosis of Liver
In brief
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). Primary Hypothesis: Compared to consultative PC, the trained hepatologist-led PC for ESLD patients will show superior primary outcome. In the event of nonsignificant superiority, the trained hepatologist-led PC led will show non-inferiority (NI) by ruling out a 4-point reduction (NI margin) in mean of the primary outcome as compared to the consultative PC. Power: The study has 83.2% power to detect minimal clinically important difference (MCID) of 9 points in mean of the primary outcome between the two randomized arms. We have 79.2% power for the noninferiority hypothesis, under assumption that the trained hepatologist-led PC arm performs better than the consultative PC arm by half of the above MCID. Setting: 19 Clinical Centers across US are recruited to participate in this study. Qualitative nested study will interview patients, caregivers and providers to assess their experiences with participating in the palliative care trial.
Key facts
- Study ID
- NCT03540771
- Run by
- Albert Einstein Healthcare Network
- People needed
- 1494
- Starts
- 2019-01-30
- Expected to finish
- 2025-08-30
- Last updated by the study team
- 2025-12-02
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Eligible patients were adults (≥18 years) with:
- cirrhosis and a decompensation event indicative of ESLD (such as ascites, variceal bleeding or hepatic encephalopathy) within the prior 6 months, or
- hepatocellular cancer (HCC) except Barcelona Stage D, or multifocal HCC (as defined by standard guidelines and confirmed by treating hepatologist).
- Additional inclusion criteria included English literacy and the capacity to complete study assessments.
- Exclusion criteria were hepatologist assessed life expectancy <6 months, prior liver transplantation, anticipated liver transplantation within 3 months, inability to consent, or receipt of PC within the previous three months.
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- Banner Health- University Medical Center — Phoenix, Arizona, United States
- UCSF Fresno — Fresno, California, United States
- Loma Linda Unversity Health — Loma Linda, California, United States
- VA West Haven — West Haven, Connecticut, United States
- University of Florida — Gainesville, Florida, United States
- Miami VA Medical Center — Miami, Florida, United States
- Indiana University — Indianapolis, Indiana, United States
- VA Boston — Boston, Massachusetts, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Kansas City VA Medical Center — Kansas City, Missouri, United States
- VA New York Harbor — Brooklyn, New York, United States
- VA Bronx — The Bronx, New York, United States
- UNC Liver Center — Chapel Hill, North Carolina, United States
- Durham V.A. Medical Center — Durham, North Carolina, United States
- Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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