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



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 120
Updated:2/13/2019
Start Date:January 30, 2019
End Date:December 30, 2023
Contact:Manisha Verma, MBBS, MPH
Email:VermaM@einstein.edu
Phone:2154561026

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Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

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).

14 Clinical Centers across US are recruited to participate in this study.

This is a two armed multicenter cluster randomized controlled trial (RCT), to assess the
effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained
hepatologist led PC). To prevent bias at the level of providers, randomization will take
place at the level of clinical centers; however patients will be the unit of inference.
Parallel to this cluster-RCT, 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 14 clinical centers to participate; 7 Veterans
Health Administration (VHA) systems and 7 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 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 visits utilizing
the same PC checklist as utilized in Model 1. The in-person visits will occur at
initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified
agenda.

Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in
different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver
dyads will be enrolled.

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
We found this trial at
14
sites
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Ann Arbor, Michigan 48109
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Boston, Massachusetts 02030
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Bronx, New York 10468
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Brooklyn, New York 11209
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Chapel Hill, North Carolina 27599
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508 Fulton Street
Durham, North Carolina 27705
919-286-0411
Durham VA Medical Center Since 1953, Durham Veterans Affairs Medical Cetner has been improving the...
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Kansas City, Missouri 64128
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Loma Linda, California 92354
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Philadelphia, Pennsylvania 19104
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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West Haven, Connecticut 06516
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