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NCT Number: NCT05998330

LiverPAL: A 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.

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Key information

Conditions

Liver Disease Chronic Advanced Cirrhosis Cirrhosis Cirrhosis, Liver Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LiverPAL

Behavioral

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.

Primary outcomes

  1. 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

  1. Patient FACIT-Pal Score longitudinally between study arms

    Time frame: Up to 6 months

    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.

  2. Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)

    Time frame: Up to 6 months

    Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.

  3. Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

    Time frame: Up to 6 months

    Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.

  4. Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)

    Time frame: Up to 6 months

    Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.

  5. Patient End-of-Life (EOL) Care Communication with Clinicians

    Time frame: Final assessment prior to patient death or at 6 months

    "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?"

  6. Documentation of Patient End-of-Life (EOL) Care Preferences

    Time frame: After patient death, up to 60 months

    Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.

Other outcomes

  1. Patient End-of-Life (EOL) Care

    Time frame: Within 30 days of patient death

    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.

  2. Caregiver Quality of Life (PROMIS-29+2)

    Time frame: Up to 6 months

    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.

  3. Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)

    Time frame: Up to 6 months

    Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms.

  4. Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.

    Time frame: Up to 6 months

    Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.

  5. Caregiver Burden (Zarit Burden Index 12, ZBI-12)

    Time frame: Up to 6 months

    Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden.

  6. Receipt of goal-concordant end-of-life care - patient wishes followed

    Time frame: At least 1 month after patient death, up to 3 months

    Bereaved caregivers will be asked "In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."

  7. Quality of Life Near Death (QOD)

    Time frame: After patient death, up to 60 months

    Bereaved caregivers will be asked "Just prior to the death of [the patient] (eg, his/her last week; when last seen), how would [participant] rate [the patient's] level of…" (1) "psychological distress?" (0 = none; 10 = extremely upset); (2) "physical distress?" (0 = none; 10 = extremely distressed); and (3) "overall quality of life in the last week of life/death?" (0 = worst possible; 10 = best possible). Ratings for these three items will be averaged (with reverse coding for the psychological and physical distress items). Scores range 0-10 with higher composite scores representing better QOD.

  8. Prolonged Grief Disorder (PG-13-R)

    Time frame: At least 12 months after patient death, up to 60 months

    Compare rates of prolonged grief disorder (PG-13-R) among bereaved caregivers between study arms. Score range 10-50 for symptom items with higher scores indicating worsening symptoms.

  9. Healthcare Utilization at End-of-Life - Hospice

    Time frame: After patient death, up to 60 months

    Compare rates of hospice utilization (yes/no) between study arms.

  10. Healthcare Utilization at End-of-Life - Hospice length of stay

    Time frame: After patient death, up to 60 months

    Compare number of days in hospice for patients admitted to hospice between study arms.

  11. Healthcare Utilization - Days alive and out of the hospital

    Time frame: Up to 6 months

    Compare days alive and out of the hospital at 6 months (180 days) after randomization

  12. Healthcare Utilization - liver transplantation

    Time frame: Up to 60 months

    Compare rates of liver transplantation (yes/no) between study arms

  13. Patient Coping (Brief COPE)

    Time frame: Up to 6 months

    Compare patient coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

  14. Caregiver Coping (Brief COPE)

    Time frame: Up to 6 months

    Compare caregiver coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.

  15. Patient Feeling Heard and Understood Scale

    Time frame: Up to 6 months

    We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' global assessment of their health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.

  16. Caregiver Feeling Heard and Understood Scale

    Time frame: Up to 6 months

    We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' caregivers' global assessment of their loved one's health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.

  17. Patient End-of-Life (EOL) Care Communication with Caregivers

    Time frame: Final assessment prior to patient death or at 6 months

    "Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"

  18. Patient Quality of Life (PROMIS-29+2)

    Time frame: Up to 6 months

    Compare patient quality of life (PROMIS-29+2) scores 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Bizup, BA

CONTACT

[email protected]

617-724-1316

William Munroe, BA

CONTACT

[email protected]

617- 726-0161

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

Acronym: LiverPAL

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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