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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Behavioral: LiverPal Intervention

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pilot; Inpatient longitudinal palliative care intervention that includes the following domains: Therapeutic relationship: Developing trust and credibility with patients and their families; Symptom management: Proactive symptom management for common advanced liver disease symptoms including pain, fatigue, anorexia, breathlessness, depression and anxiety; Coping with illness: Introduction of strategies to improve adjustment and meaning in life; bolstering caregiver coping; Prognostic awareness and illness understanding: Assessing patients' level of prognostic awareness and discussing strategies to help patients cope with uncertainty; Treatment decision-making: Supporting patients and caregivers in their medical decision-making and assessing their values in decision-making; End-of-life care: Review/discuss selection of healthcare proxy, preferences for end-of-life care

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Association for the Study of Liver Diseases

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: June 28, 2021
• First Submitted That Met QC Criteria: June 28, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Fibrosis; Liver Diseases; Liver Cirrhosis
• Other Study ID Numbers: 2021P001402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No