An Integrative Model for Palliative Care in End-Stage Liver Disease

The purpose of this research study is to understand the impact of palliative care in ESLD on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in ESLD.

Study Overview

• Status: Completed
• Conditions: End Stage Liver DIsease
• Intervention / Treatment: Other: Standard of care including palliative care

Detailed Description

Patients with end-stage liver disease (ESLD) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. Palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. While palliative care consults are used in those with ESLD, despite the pain and suffering that accompanies ESLD, palliative care is often used too little and too late.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with ESLD and their caregivers

Description

Inclusion Criteria:

Primary participant:

• admission for decompensated cirrhosis, age ≥ 18
• willingness to sign consent
• able to read and understand English
• presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, HE, hepatohydrothorax, AKI, HRS and/or variceal bleeding) or HCC

Caregiver:

• identified as the primary caregiver of the participant
• age ≥ 18
• willingness to sign consent
• able to read and understand English

Exclusion Criteria:

Primary participant:

• prior liver transplant
• lack of capacity to provide informed consent (in the judgement of the investigator)
• already in receipt of palliative or hospice care
• those who are likely to receive a LT during the index admission

Caregiver:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

End Stage Liver Disease (ESLD); Patients with ESLD

Other: Standard of care including palliative care; Usual care includes laboratory evaluations, imaging, and certain procedures and medications. In some cases of patients undergoing transplant evaluation, usual care will also include multiple visits with members of the liver transplant team. A palliative care consult will also be part of standard of care. The primary goal of the palliative care consult is not to arrange hospice (though that can be done in appropriate situations) but to identify and try to address the impacts of the disease and its symptoms on patient's life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptom intensity	Edmonton Symptom Assessment System (ESAS) - participants rate the intensity of common symptoms on 0-10 scale with 0= no symptom and 10=worst symptom imaginable. Scores range from 0 to 90 with higher scores indicating worse symptoms.	Up to 60 days
Change in liver disease QOL	Short-Form Liver Disease QOL - The SF-LDQOL includes 36 disease-targeted items representing nine domains: symptoms of liver disease, effects of liver disease, memory/concentration, sleep, hopelessness, distress, loneliness, stigma of liver disease and sexual problems. The minimum and maximum values of the scale are 0-100 with higher scores indicating better QOL.	Up to 60 days
Change in depression	Patient Health Questionnaire 9 (PHQ-9) is a self-report instrument which assesses depression. Scores range from 0 to 27 with higher scores indicating worse depression.	Up to 60 days
Change in anxiety	Generalized Anxiety Disorder 7-Item Scale (GAD-7) is a self-report instrument which assesses anxiety. Scores range from 0 to 21 with higher scores indicating greater anxiety.	Up to 60 days
Change in perform ordinary tasks	The Karnofsky Performance Status will be used to assess participants ability to perform ordinary tasks. Scores range from 0 to 100 with higher scores indicating greater ability.	Up to 60 days
Change in caregiver burden	The Zarit Burden Interview	Up to 60 days
Hospital readmissions and/or Emergency room (ER) visits	Number of participants with ER visits or who are readmitted to the hospital during the study period	60 days

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Joel Wedd, MD, MPH, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): December 12, 2022
• Study Completion (Actual): December 12, 2022

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: HM20023178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No