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

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