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

Cirrhosis, Liver Clinical Trial

— LiverPal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04953143
• Other study ID #: 2021P001402
• Status: Completed
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: August 16, 2022

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

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

1. Ascites (requiring diuretics or large volume paracenteses)

2. Hepatic encephalopathy (requiring medical therapy)

3. History of variceal bleed episode within 1 year of enrollment

2. Admitted to the general medicine service

3. Ability fo communicate in English and provide informed consent

4. Have a score = 7 on the Short Portable Mental Status Questionnaire

Patient Exclusion Criteria:

1. Patients with severe hepatic encephalopathy or any other comorbid condition which the primary medical team believes prohibits compliance with study procedures

2. Patients with advanced malignancies being treated with palliative intent

3. Patients already receiving specialty palliative care and/or hospice care Caregiver Eligibility Criteria

1. A relative or friend of eligible patient, who lives with them and has in-person contact with them at least twice per week

2. Verbally fluent in English or able to complete questionnaires with the help of an interpreter

3. 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.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Liver Cirrhosis
• Liver Diseases

Intervention

Behavioral:
• LiverPal Intervention
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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	American Association for the Study of Liver Diseases

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LiverPal intervention refinement	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	Time Frame: Up to 1 year