Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
NCT ID: NCT03540771
Last Updated: 2025-12-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1494 participants
INTERVENTIONAL
2019-01-30
2025-08-30
Brief Summary
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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.
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Detailed Description
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Embedded within this cluster-RCT is a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.
To execute this project, we have identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.
Comparative Approaches:
1. Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person or telehealth visits at initial, 1, 2 and 3 months. .
2. Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person or telehealth visits utilizing the same PC checklist as utilized in Model 1. The study visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.
Study visits in both models could occur in-person or telehealth based, especially during in-person visit restrictions due to COVID pandemic.
Adult patients with end stage liver disease and their caregivers 18 years of age or older will be enrolled.
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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Model 1: Consultative Palliative Care
Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.
Palliative Care
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 2: Trained Hepatologist- led PC
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
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
Interventions
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Palliative Care
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
Eligibility Criteria
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Inclusion Criteria
1. cirrhosis and a decompensation event indicative of ESLD (such as ascites, variceal bleeding or hepatic encephalopathy) within the prior 6 months, or
2. hepatocellular cancer (HCC) except Barcelona Stage D, or multifocal HCC (as defined by standard guidelines and confirmed by treating hepatologist).
18 Years
120 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
Albert Einstein Healthcare Network
OTHER
Responsible Party
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Manisha Verma
Director, Research, Department of Medicine
Principal Investigators
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Manisha Verma, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein Healthcare Network
Victor Navarro, MD
Role: PRINCIPAL_INVESTIGATOR
Albert Einstein Healthcare Network
Locations
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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
Countries
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References
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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.
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.
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.
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. 2025 Oct 8:S0885-3924(25)00871-1. doi: 10.1016/j.jpainsymman.2025.09.028. Online ahead of print.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with detailed outcomes and procedures
Document Type: Statistical Analysis Plan: Detailed Statistical Analysis Plan
Related Links
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Other Identifiers
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Pro00092149
Identifier Type: -
Identifier Source: org_study_id
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