Liver Disease ChronicLiverPALNCT05998330
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
A study testing LiverPAL in people with Liver Disease Chronic and End Stage Liver DIsease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis
- What is being tested?
- LiverPAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient 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
Patient 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
Caregiver Exclusion Criteria
- Inability to comprehend English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Grace Bizup, BA, 617-724-1316, gbizup@mgh.harvard.edu
Will Munroe, BA, 617- 726-0161, wlmunroe@mgh.harvard.edu
About this study
Official title: LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
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.
Read the 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.
- Conditions
- Liver Disease Chronic, End Stage Liver DIsease, Cirrhosis, Cirrhosis, Liver, Advanced Cirrhosis
- Being tested
- LiverPAL
- Medical subject headings
- End Stage Liver Disease, Fibrosis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiverPALBehavioural
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Hepatology Care | No intervention | Usual hepatology care |
| Usual Hepatology Care with Early Palliative Care | Experimental | Usual hepatology care with early palliative care Receives: Behavioral: LiverPAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (6)
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Patient End-of-Life (EOL) Care Communication with Clinicians
"Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"
Measured: Final assessment prior to patient death or at 6 months
Documentation of Patient End-of-Life (EOL) Care Preferences
Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.
Measured: After patient death, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start20 Sep 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease ChronicStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nneka nnaoke Ufere, Massachusetts General Hospital
- Investigators
- Nneka Ufere, MD MSCE, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998330
- Sponsor's protocol ID
- 2023P001894
- Other IDs
- 80736, 242379, 243432, 236965
- Acronym
- LiverPAL
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No