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

NCT05238779 | Completed

• 1 other identifier: HM20023178
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End Stage Liver DIsease

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (1)

End Stage Liver Disease (ESLD)

Patients with ESLD

Other: Standard of care including palliative care

Interventions

Standard of care including palliative care OTHER

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.

End Stage Liver Disease (ESLD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with ESLD and their caregivers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Joel Wedd, MD, MPH

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 14, 2022
• Study Start: January 6, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 12, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)