Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)

NCT03540771 | Completed Results DMC

• 1 other identifier: Pro00092149
• Study Type: interventional
• Target: 1,494
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

End Stage Liver Disease; Decompensated Cirrhosis of Liver

Keywords

palliative care; hepatology; decompensated cirrhosis

Outcome Measures

Primary Outcomes (1)

• Quality of Life (QOL)

  FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary) will be used to assess QOL. This is a 45 item self-reported instrument. FACT-Hep total score is the primary outcome. The scores range from 0 to 180. Higher scores reflect better QOL. This measure is for patients only.

  Mean change in FACT-Hep total score from baseline to 3 months

Secondary Outcomes (9)

• Patient's Symptom Burden

  Change in ESAS total score from baseline to 3 months

• Patient's Depression Severity

  Change in PHQ-9 scores from baseline to 3 months

• Patient Satisfaction

  Change in FAMCARE-P scores from baseline to 3 months.

• Distress

  Change in Distress from baseline to 3 months

• Goal Concordant Care Questionnaire/ GCC (Patients)

  Change in GCC scales from baseline to 3 months

Study Arms (2)

Model 1: Consultative Palliative Care

ACTIVE COMPARATOR

Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.

Other: Palliative Care

Model 2: Trained Hepatologist- led PC

ACTIVE COMPARATOR

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

Other: Palliative Care

Interventions

Palliative Care OTHER

The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives

Model 1: Consultative Palliative Care; Model 2: Trained Hepatologist- led PC

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (19)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Banner Health- University Medical Center

Phoenix, Arizona, 85006, United States

Location

UCSF Fresno

Fresno, California, 93701, United States

Location

Loma Linda Unversity Health

Loma Linda, California, 92354, United States

Location

VA West Haven

West Haven, Connecticut, 06516, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Miami VA Medical Center

Miami, Florida, 33125, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

VA Boston

Boston, Massachusetts, 02130, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

VA New York Harbor

Brooklyn, New York, 11209, United States

Location

VA Bronx

The Bronx, New York, 10468, United States

Location

UNC Liver Center

Chapel Hill, North Carolina, 27599, United States

Location

Durham V.A. Medical Center

Durham, North Carolina, 27705, United States

Location

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (5)

• Verma M, Tapper EB, Singal AG, Navarro V. Nonhospice Palliative Care Within the Treatment of End-Stage Liver Disease. Hepatology. 2020 Jun;71(6):2149-2159. doi: 10.1002/hep.31226.

  PMID: 32167615 BACKGROUND

• DeNofrio JC, Verma M, Kosinski AS, Navarro V, Taddei TH, Volk ML, Bakitas M, Ramchandran K. Palliative Care Always: Hepatology-Virtual Primary Palliative Care Training for Hepatologists. Hepatol Commun. 2022 Apr;6(4):920-930. doi: 10.1002/hep4.1849. Epub 2021 Oct 31.

  PMID: 34719137 BACKGROUND

• Verma M, Bakitas MA. Creating Effective Models for Delivering Palliative Care in Advanced Liver Disease. Curr Hepatol Rep. 2021;20(2):43-52. doi: 10.1007/s11901-021-00562-0. Epub 2021 Apr 10.

  PMID: 33868897 BACKGROUND

• Hoppmann N, Bakitas M, Stockdill M, DeNofrio J, Navarro V, Verma M. Palliative Care for Advanced Liver Disease: Hepatology and Palliative Care Specialists Experiences. J Pain Symptom Manage. 2026 Jan;71(1):157-167. doi: 10.1016/j.jpainsymman.2025.09.028. Epub 2025 Oct 8.

  PMID: 41072740 DERIVED

• Verma M, Kosinski AS, Volk ML, Taddei T, Ramchandran K, Bakitas M, Green K, Green L, Navarro V. Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial. J Palliat Med. 2019 Sep;22(S1):34-43. doi: 10.1089/jpm.2019.0121.

  PMID: 31486722 DERIVED

Related Links

• PCORI web release

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Manisha Verma, MD, MPH. Director, Research
• Organization: Albert Einstein Healthcare Network

Manisha.Verma@jefferson.edu

2154561026

Study Officials

• Manisha Verma, MD, MPH

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

• Victor Navarro, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study investigators were masked to comparative outcomes measures until the study was completed and database was locked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research, Department of Medicine

Model Details: Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), versus Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: May 30, 2018
• Study Start: January 30, 2019
• Primary Completion: June 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 2, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)