LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease

Frequently patients with advanced liver disease experience physical and emotional symptoms during their hospitalization that can may cause a level of discomfort to both the patient and the family members that surround them.

This study involves the early introduction of a team of clinicians that specialize in the lessening (palliation) of many of these discomforting symptoms. This team of clinicians is called the palliative care team and they focus on ways to improve pain and other symptom management and to assist patients and their families in coping with the physical, emotional and social issues associated with a diagnosis of advanced liver disease. The team consists of physicians and advance practice nurses who have been specially trained in the care of patients facing serious illness and their caregivers.

The investigators are studying the feasibility of delivering this program, the acceptability and satisfaction with the program, and changes in the quality of life, illness understanding, and symptoms of hospitalized patients who receive the program and their caregivers. The study will use a series of questionnaires to measure the study participants' quality of life, physical symptoms, illness and prognostic understanding, and mood. Study questionnaires will be completed in the hospital, home or clinic. Qualitative interviews will be conducted with hepatology and palliative care clinicians as well as patients and caregivers.

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Key information

Conditions

Cirrhosis, Liver Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

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

Patient Inclusion Criteria:

Adult (≥ 18 years old) with advanced liver disease defined as cirrhosis complicated by one of the following (new or ongoing) clinically-evidence decompensating events

Ascites (requiring diuretics or large volume paracenteses)
Hepatic encephalopathy (requiring medical therapy)
History of variceal bleed episode within 1 year of enrollment
Admitted to the general medicine service
Ability fo communicate in English and provide informed consent
Have a score ≥ 7 on the Short Portable Mental Status Questionnaire

Patient Exclusion Criteria:

Patients with severe hepatic encephalopathy or any other comorbid condition which the primary medical team believes prohibits compliance with study procedures
Patients with advanced malignancies being treated with palliative intent
Patients already receiving specialty palliative care and/or hospice care

Caregiver Eligibility Criteria

A relative or friend of eligible patient, who lives with them and has in-person contact with them at least twice per week
Verbally fluent in English or able to complete questionnaires with the help of an interpreter
Age 18 or older

Clinician Selection: All palliative care clinicians who deliver the LiverPal intervention will participate in qualitative interviews. Inpatient clinicians who provided direct care to enrolled patients in either the inpatient or outpatient setting will also be eligible to participate in the qualitative interviews.

Treatment and study plan

LiverPal Intervention

Behavioral

Inpatient longitudinal palliative care intervention

Patients will complete baseline assessments and will be followed by the palliative care clinicians delivering the LiverPal intervention during each of their hospitalizations over a 3 month period

LiverPal intervention domains include the following:

Therapeutic relationship
Symptom management
Coping with illness
Prognostic awareness and illness understanding
Treatment decision-making
End-of-life care

Primary outcomes

LiverPal intervention refinement

Time frame: Time Frame: Up to 1 year

The investigators will conduct qualitative interviews with the patients and caregivers enrolled in the open pilot phase as well as LiverPal clinicians to elicit stakeholder feedback on the intervention. The qualitative component of the exit interviews will explore 1) patients', caregivers' and clinicians' perceptions of the acceptability and content of LiverPal; 2) any barriers or challenges to providing or receiving LiverPal; and 3) suggested modifications to LiverPal to improve its delivery in the inpatient setting

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

American Association for the Study of Liver Diseases

Registry information

Acronym: LiverPal

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jul 7, 2021
Registry last updated: Jun 27, 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.

Published trials that share one or more normalized conditions with this study.

Completed