An Integrative Model for Palliative Care in End-Stage Liver Disease
- Conditions
- End Stage Liver DIsease
- Interventions
- Other: Standard of care including palliative care
- Registration Number
- NCT05238779
- Lead Sponsor
- Virginia Commonwealth University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description End Stage Liver Disease (ESLD) Standard of care including palliative care Patients with ESLD
- Primary Outcome Measures
Name Time Method Change in symptom intensity Up to 60 days 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.
Change in depression Up to 60 days 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.
Change in liver disease QOL Up to 60 days 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.
Change in anxiety Up to 60 days 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.
Change in perform ordinary tasks Up to 60 days 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.
Change in caregiver burden Up to 60 days The Zarit Burden Interview
Hospital readmissions and/or Emergency room (ER) visits 60 days Number of participants with ER visits or who are readmitted to the hospital during the study period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States