LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Disease Chronic
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Nneka nnaoke Ufere
Assistant Professor
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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)
- •Ability to comprehend English
Exclusion Criteria
- •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
- •Are already receiving hospice care
- •Receive a score of \<10 on the Simplified Animal Naming Test
- •Caregiver Inclusion Criteria
- •Adult caregiver (≥ 18 years of age)
- •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
- •Ability to comprehend English and can complete questionnaires
Outcomes
Primary Outcomes
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Time Frame: Up to 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.
Secondary Outcomes
- Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)(Up to 6 months)
- Patient End-of-Life (EOL) Care Communication with Clinicians(Final assessment prior to patient death or at 6 months)
- Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)(Up to 6 months)
- Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)(Up to 6 months)
- Patient FACIT-Pal Score longitudinally between study arms(Up to 6 months)
- Documentation of Patient End-of-Life (EOL) Care Preferences(After patient death, up to 60 months)