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

Cirrhosis Clinical Trial

— LiverPAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998330
• Other study ID #: 2023P001894
• Secondary ID: 8073624237924343
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: July 2027

Study information

• Verified date: June 2024
• Source: Massachusetts General Hospital
• Contact: Malia Armstrong, BA
• Phone: (617)-643-4327
• Email: marmstrong6[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cirrhosis
• Cirrhosis
• Cirrhosis, Liver
• End Stage Liver DIsease
• Fibrosis
• Liver Cirrhosis
• Liver Disease Chronic
• Liver Diseases

Intervention

Behavioral:
• LiverPAL
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Within 30 days of patient death
Other	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.	Up to 6 months
Other	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.	Up to 6 months
Other	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.	Up to 6 months
Other	Caregiver Burden (Zarit Burden Index 12, ZBI-12)	Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden.	Up to 6 months
Other	Receipt of goal-concordant end-of-life care - patient wishes followed	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."	At least 1 month after patient death, up to 3 months
Other	Quality of Life Near Death (QOD)	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.	After patient death, up to 60 months
Other	Prolonged Grief Disorder (PG-13-R)	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.	At least 12 months after patient death, up to 60 months
Other	Healthcare Utilization at End-of-Life - Hospice	Compare rates of hospice utilization (yes/no) between study arms.	After patient death, up to 60 months
Other	Healthcare Utilization at End-of-Life - Hospice length of stay	Compare number of days in hospice for patients admitted to hospice between study arms.	After patient death, up to 60 months
Other	Healthcare Utilization - Days alive and out of the hospital	Compare days alive and out of the hospital at 6 months (180 days) after randomization	Up to 6 months
Other	Healthcare Utilization - liver transplantation	Compare rates of liver transplantation (yes/no) between study arms	Up to 60 months
Other	Patient Coping (Brief COPE)	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.	Up to 6 months
Other	Caregiver Coping (Brief COPE)	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.	Up to 6 months
Other	Patient Feeling Heard and Understood Scale	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.	Up to 6 months
Other	Caregiver Feeling Heard and Understood Scale	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.	Up to 6 months
Other	Patient End-of-Life (EOL) Care Communication with Caregivers	"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?"	Final assessment prior to patient death or at 6 months
Other	Patient Quality of Life (PROMIS-29+2)	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.	Up to 6 months
Primary	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.	Up to 4 weeks
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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?"	Final assessment prior to patient death or at 6 months
Secondary	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.	After patient death, up to 60 months