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

Primary Purpose

Cirrhosis, Liver

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LiverPal Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Hepatology 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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pilot

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 28, 2021
Last Updated
June 25, 2023
Sponsor
Massachusetts General Hospital
Collaborators
American Association for the Study of Liver Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT04953143
Brief Title
LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease
Acronym
LiverPal
Official Title
LiverPAL: A Pilot Study of Inpatient Palliative Care for Patients With Advanced Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
August 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
American Association for the Study of Liver Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilot
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
LiverPal Intervention
Intervention Description
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 Outcome Measure Information:
Title
LiverPal intervention refinement
Description
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
Time Frame: Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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