Introducing palliative care for patients with end stage liver disease
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
This study is testing two different ways to provide palliative care for people with end stage liver disease to see which one helps improve their quality of life better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1260 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Albert Einstein Healthcare Network Academic / other |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT03540771 on ClinicalTrials.gov |
What this trial studies
This study compares two models of palliative care for patients with end stage liver disease: a consultative model with direct access to palliative care providers and a model where trained hepatologists deliver palliative care. It is a multicenter cluster randomized controlled trial involving 14 clinical centers across the U.S. The primary outcome is the change in quality of life over three months, assessed using the FACT-Hep scale. Additionally, a qualitative study will gather patient and caregiver experiences through semi-structured interviews.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with new onset or ongoing complications of end stage liver disease, including those with hepatocellular cancer.
Not a fit: Patients with a MELD score greater than 30 or an expected life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from end stage liver disease.
How similar studies have performed: Other studies have shown promising results with similar palliative care approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with new onset or ongoing complications of End Stage Liver Disease including Hepatocellular Cancer (HCC) (irrespective of their transplant status), with a caregiver willing to participate. Exclusion Criteria: MELD\> 30 or Expected life expectancy of less than 6 months
Where this trial is running
Birmingham, Alabama and 18 other locations
- University of Alabama — Birmingham, Alabama, United States (Recruiting)
- Banner Health- University Medical Center — Phoenix, Arizona, United States (Recruiting)
- UCSF Fresno — Fresno, California, United States (Recruiting)
- Loma Linda Unversity Health — Loma Linda, California, United States (Recruiting)
- VA West Haven — West Haven, Connecticut, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Miami VA Medical Center — Miami, Florida, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- VA Boston — Boston, Massachusetts, United States (Recruiting)
- University of Michigan Medical Center — Ann Arbor, Michigan, United States (Recruiting)
- Kansas City VA Medical Center — Kansas City, Missouri, United States (Recruiting)
- VA Bronx — Bronx, New York, United States (Recruiting)
- VA New York Harbor — Brooklyn, New York, United States (Recruiting)
- UNC Liver Center — Chapel Hill, North Carolina, United States (Recruiting)
- Durham V.A. Medical Center — Durham, North Carolina, United States (Completed)
- Corporal Michael J. Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Manisha Verma, MBBS, MPH — Albert Einstein Healthcare Network
- Study coordinator: Manisha Verma, MBBS, MPH
- Email: VermaM@einstein.edu
- Phone: 2154561026
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.