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

NCT ID: NCT05238779

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2022-12-12

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.

Conditions

End Stage Liver DIsease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

End Stage Liver Disease (ESLD)

Patients with ESLD

Standard of care including palliative care

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Wedd, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20023178

Identifier Type: -

Identifier Source: org_study_id