Clinical trial NCT05998330: LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Official title: LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Disease Chronic
End Stage Liver DIsease
Cirrhosis
Cirrhosis, Liver
Advanced Cirrhosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

Detailed description: The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).

The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.

Eligibility criteria: Patient Inclusion Criteria:

1. Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:

   * Ascites (requiring diuretics or serial large volume paracenteses)
   * Spontaneous bacterial peritonitis
   * Hepatic hydrothorax (requiring diuretics)
   * Variceal bleed (with one or more occurrences)
   * Overt hepatic encephalopathy (requiring medications)
2. Ability to comprehend English

Patient Exclusion Criteria:

1. Prior history of liver transplantation
2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
4. Presence of hepatocellular carcinoma beyond Milan criteria
5. Are already receiving hospice care
6. Receive a score of \<10 on the Simplified Animal Naming Test

Caregiver Inclusion Criteria

1. Adult caregiver (≥ 18 years of age)
2. A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
3. Ability to comprehend English and can complete questionnaires

Caregiver Exclusion Criteria

1. Inability to comprehend English

Primary outcomes:
measure: Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Patient FACIT-Pal Score longitudinally between study arms
timeFrame: Up to 6 months
measure: Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)
timeFrame: Up to 6 months
measure: Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
timeFrame: Up to 6 months
measure: Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
timeFrame: Up to 6 months
measure: Patient End-of-Life (EOL) Care Communication with Clinicians
timeFrame: Final assessment prior to patient death or at 6 months
measure: Documentation of Patient End-of-Life (EOL) Care Preferences
timeFrame: After patient death, up to 60 months
Other outcomes:
measure: Patient End-of-Life (EOL) Care
timeFrame: Within 30 days of patient death
measure: Caregiver Quality of Life (PROMIS-29+2)
timeFrame: Up to 6 months
measure: Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
timeFrame: Up to 6 months
measure: Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.
timeFrame: Up to 6 months
measure: Caregiver Burden (Zarit Burden Index 12, ZBI-12)
timeFrame: Up to 6 months
measure: Receipt of goal-concordant end-of-life care - patient wishes followed
timeFrame: At least 1 month after patient death, up to 3 months
measure: Quality of Life Near Death (QOD)
timeFrame: After patient death, up to 60 months
measure: Prolonged Grief Disorder (PG-13-R)
timeFrame: At least 12 months after patient death, up to 60 months
measure: Healthcare Utilization at End-of-Life - Hospice
timeFrame: After patient death, up to 60 months
measure: Healthcare Utilization at End-of-Life - Hospice length of stay
timeFrame: After patient death, up to 60 months
measure: Healthcare Utilization - Days alive and out of the hospital
timeFrame: Up to 6 months
measure: Healthcare Utilization - liver transplantation
timeFrame: Up to 60 months
measure: Patient Coping (Brief COPE)
timeFrame: Up to 6 months
measure: Caregiver Coping (Brief COPE)
timeFrame: Up to 6 months
measure: Patient Feeling Heard and Understood Scale
timeFrame: Up to 6 months
measure: Caregiver Feeling Heard and Understood Scale
timeFrame: Up to 6 months
measure: Patient End-of-Life (EOL) Care Communication with Caregivers
timeFrame: Final assessment prior to patient death or at 6 months
measure: Patient Quality of Life (PROMIS-29+2)
timeFrame: Up to 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nneka Ufere, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: