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

End Stage Liver DIsease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238779
• Other study ID #: HM20023178
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: December 12, 2022

Study information

• Verified date: July 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 12, 2022
• Est. primary completion date: December 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver DIsease
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in caregiver burden	The Zarit Burden Interview	Up to 60 days
Primary	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