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Completed

NCT Number: NCT05238779

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.

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Key information

Conditions

End Stage Liver Disease Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in symptom intensity

    Time frame: 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.

  2. Change in liver disease QOL

    Time frame: 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.

  3. Change in depression

    Time frame: 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.

  4. Change in anxiety

    Time frame: 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.

  5. Change in perform ordinary tasks

    Time frame: 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.

  6. Change in caregiver burden

    Time frame: Up to 60 days

    The Zarit Burden Interview

  7. Hospital readmissions and/or Emergency room (ER) visits

    Time frame: 60 days

    Number of participants with ER visits or who are readmitted to the hospital during the study period

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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