LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ascites (requiring diuretics or serial large volume paracenteses)
Spontaneous bacterial peritonitis
Hepatic hydrothorax (requiring diuretics)
Variceal bleed (with one or more occurrences)
Disqualifiers
Prior history of liver transplantation
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
Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
Presence of hepatocellular carcinoma beyond Milan criteria
Trial design
Design model
Single group
Treatments tested in this trial
LiverPAL
BehavioralThe intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Usual Hepatology CareNo intervention 0 interventions
Group B: Usual Hepatology Care with Early Palliative CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life.
Time frame
Up to 4 weeksSecondary outcomes
1
Patient FACIT-Pal Score longitudinally between study arms
Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life.
Time frame
Up to 6 months2
Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)
Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.
Time frame
Up to 6 months3
Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.
Time frame
Up to 6 months4
Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.
Time frame
Up to 6 monthsOther outcomes
1
Patient End-of-Life (EOL) Care
Compare rate of receipt of intensive EOL care (renal replacement therapy, mechanical ventilation, and/or cardiopulmonary resuscitation or death in the intensive care unit) between study arms.
Time frame
Within 30 days of patient death2
Caregiver Quality of Life (PROMIS-29+2)
Compare caregiver quality of life (PROMIS-29+2) between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.
Time frame
Up to 6 months3
Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms.
Time frame
Up to 6 months4
Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.
Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.
Time frame
Up to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov