Palliative Care for Non-Malignant Diseases (COMPASS Trial) — COMPASS  

Liver Cirrhosis Clinical Trial

Official title: The Creation of Models for Palliative Assessments to Support Severe Illness (COMPASS) Investigation: Testing Early and Ongoing Implementation of Palliative Care for Incurable Non-malignant Diseases

Status Terminated

Clinical Trial Summary

The purpose of this study is to evaluate, through a randomized controlled trial, the impact of integrated comprehensive palliative care services on time to first hospital readmission and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The intervention includes comprehensive, standardized palliative care services for adult hepatology cirrhosis patients for which prognosis is poor.

Clinical Trial Description

Palliative care is specialized medical care focused on providing patients with relief from the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis, by anticipating, preventing, and treating suffering. Palliative care aims to provide patients and their families with services to help patients make the best possible medical decisions in the face of serious illness. Unfortunately it is often thought to be synonymous with hospice care and therefore underutilized as a part of standard care. Patients with chronic liver disease or cirrhosis may be a particularly underserved population for palliative care, as palliative care may be disregarded until hope of liver transplantation is lost.

Study Description:

• Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced liver disease and poor prognosis will be randomized to receive either usual hepatic care or usual hepatic care with comprehensive palliative care services.

• Participants randomized to the intervention arm will receive patient-friendly informational materials, a comprehensive initial palliative care consultation, and follow-up consultations while inpatient. After discharge from hospital, follow-up consults will occur via telephone contact. Telephone contacts will occur on a flexible schedule based on needs and wishes of the participant at a minimum frequency of one contact per month.

• Participants will receive the palliative care intervention for at least 1 year after randomization to the intervention arm or until death.

• Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a meeting is requested by the patient, the family, or treating physician. These consultations include the same palliative care services as the intervention arm, excluding the telephone follow-up consultations.

• All participants will complete quality of life, mood, and satisfaction with care assessments at specified time points for 1 year after randomization or until death. Optional caregiver participation includes completion of satisfaction with care assessments.

Specific aims include:

1. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on time to first hospital readmission within 1-year post randomization.

2. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on other hospital utilization, including days alive out of hospital within 6- months post randomization, total days in hospital (and ICU) within 1-year post randomization, number and cost of hospital admissions within 1-year post randomization, median length of stay per admission, transfers and time to hospice placement, and survival within 1-year post randomization.

3. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on qualify of life.

4. Assess the impact of systematic, comprehensive palliative care services compared to usual hepatic care on patient/caregiver satisfaction.

5. Evaluate the fidelity of the palliative care intervention and assess the generalizability of implementing a large-scale Palliative Care program. ;

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• NASH (Non-Alcoholic Steatohepatitis)
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT03022630
• Study type: Interventional
• Source: Vanderbilt University Medical Center
• Status: Terminated
• Phase: N/A
• Start date: February 6, 2017
• Completion date: June 21, 2018