PAL-Liver

Currently Recruiting: Participants

Study Drug/Intervention: Palliative care administered by PC providers versus palliative care administered by hepatologists who received PC training

Anticipated Sample Size: 945 patients with or without caregivers

Study Timeline: This study is expected to conclude in May 2025.

ClinicalTrials.gov ID: NCT03540771

What is PAL-Liver?

This is a two-armed cluster randomized controlled trial (RCT). Randomization will take place at the level of clinical centers, and will be stratified by VA vs non-VA. Each arm will have initially 7 clinical centers. Additional centers will be added if needed. Standardized protocols (including visit agenda) will be followed at each of the clinical centers to maintain intervention fidelity across sites.

Unique Aspects of the Project

Despite clear evidence that Palliative Care (PC) improves QOL and symptom burden in other serious illnesses, referral of End-Stage Liver Disease (ESLD) patients to PC specialists is infrequent and often delayed until the very end of life. Hence, the current proposal aims to build evidence in support of integration of PC into the routine care of ESLD patients who suffer from a high symptom burden, by comparing a Consultative PC model to trained hepatologist-led PC delivery.

Study Objectives

To assess the comparative effectiveness of two Palliative Care Delivery models for patients with end-stage liver disease on improving quality of life (QOL).

• Model 1: Consultative PC (i.e. consultation with a board-certified or board-eligible PC specialist provider)
• Model 2: Trained hepatologist-led PC intervention (i.e. hepatologist trained to deliver PC services)

Duration of Study Participation

Each participating patient/caregiver dyad will participate for 3 months of study intervention, and 9 months of follow-up for a total of 12-months of participation. Survival data will be collected for 12 months of participation. No study visits are mandated during the 9 months follow-up period.

Study Follow-Up

Each participating patient/caregiver dyad will participate for 3 months of study intervention, and 9 months of follow-up for a total of 12-months of participation. Survival data will be collected for 12 months of participation. No study visits are mandated during the 9 month follow up period.

• PL: Samantha Raines