Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
Public ClinicalTrials.gov record NCT03540771. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03540771
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,494 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 120 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2019 (Actual)
- Primary completion
- Jun 30, 2025 (Actual)
- Completion
- Aug 30, 2025 (Actual)
- Last update posted
- Dec 2, 2025
2019 – 2025
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35233 | — |
| Banner Health- University Medical Center | Phoenix | Arizona | 85006 | — |
| UCSF Fresno | Fresno | California | 93701 | — |
| Loma Linda Unversity Health | Loma Linda | California | 92354 | — |
| VA West Haven | West Haven | Connecticut | 06516 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Miami VA Medical Center | Miami | Florida | 33125 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| VA Boston | Boston | Massachusetts | 02130 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| VA New York Harbor | Brooklyn | New York | 11209 | — |
| VA Bronx | The Bronx | New York | 10468 | — |
| UNC Liver Center | Chapel Hill | North Carolina | 27599 | — |
| Durham V.A. Medical Center | Durham | North Carolina | 27705 | — |
| Corporal Michael J. Crescenz VA Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03540771, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 2, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03540771 live on ClinicalTrials.gov.