Trial Outcomes & Findings for Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD) (NCT NCT03540771)

Last Updated: 2025-12-02

Results Overview

FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary) will be used to assess QOL. This is a 45 item self-reported instrument. FACT-Hep total score is the primary outcome. The scores range from 0 to 180. Higher scores reflect better QOL. This measure is for patients only.

Recruitment status

COMPLETED

Study phase

Target enrollment

1494 participants

Primary outcome timeframe

Mean change in FACT-Hep total score from baseline to 3 months

Results posted on

2025-12-02

Participant Flow

This study enrolled patients and caregivers separately. 935 Patients ( 516 in Model 1 and 419 in Model 2) and 559 caregivers (310 in Model 1 and 249 in Model 2) were enrolled. Recruitment occured from January 2019 to March 2025, with completion of data collection and database lock by June 30, 2025. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers.

This study consented and enrolled patients and caregivers separately. 935 Patients ( 516 in Model 1 and 419 in Model 2) and 559 caregivers (310 in Model 1 and 249 in Model 2) were enrolled.

Unit of analysis: Clinical Centers

Participant milestones

Participant milestones
Measure	Model 1: Consultative Palliative Care Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Overall Study STARTED	826 8	668 11
Overall Study COMPLETED	558 8	456 11
Overall Study NOT COMPLETED	268 0	212 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Mean change in FACT-Hep total score from baseline to 3 months

Population: Modified Intention to treatment population excludes patients who got a liver transplant or were transferred to Hospice within 3 months of enrollment (i.e. before completion of intervention).

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Quality of Life (QOL)	7.02 score on a scale Interval 4.34 to 9.71	8.01 score on a scale Interval 5.38 to 10.65

SECONDARY outcome

Timeframe: Change in ESAS total score from baseline to 3 months

Modified Edmonton Symptom Assessment Scale (ESAS) evaluated 13 symptoms (tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, shortness of breath, muscle cramps, sexual function, sleep, itch, pain) on a 10-point scale, where 0 is no symptom and 10 is the maximum severity of symptom. The total score ranges from 0-130. Higher scores reflect higher symptom burden. This measure is for patients only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Patient's Symptom Burden	-5.31 score on a scale Interval -7.59 to -3.02	-7.52 score on a scale Interval -9.89 to -5.15

SECONDARY outcome

Timeframe: Change in PHQ-9 scores from baseline to 3 months

PHQ-9 (Personal Health Questionnaire) is one of the very commonly used tools to assess severity of depression in different settings, and has 9 questions. Each question is rated on a 4 point scale, with total score ranging from 0 to 27. Higher scores reflects greater severity of depression. Scores from 0-4 equates to no depression, 5-9 mild, 10-14 moderate, 15-19 mod severe and \>20 reflects severe depression. This measure is for patients only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Patient's Depression Severity	-0.90 score on a scale Interval -1.49 to -0.31	-1.18 score on a scale Interval -1.78 to -0.57

SECONDARY outcome

Timeframe: Change in FAMCARE-P scores from baseline to 3 months.

FAMCARE-P13 (Family Satisfaction with Cancer Care- Patient scale) is a brief validated instrument used to assess patient satisfaction with outpatient palliative care interventions. It consists of 13 questions, with Likert scale response options. Higher scores imply better satisfaction from the care received. This measure is for patients only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Patient Satisfaction	0.91 score on a scale Interval -0.15 to 1.96	3.37 score on a scale Interval 2.24 to 4.49

SECONDARY outcome

Timeframe: Change in Distress from baseline to 3 months

Distress thermometer (DT) ranks level of distress from 0- 10, Higher scores reflect higher distress. This is for patients only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Distress	-0.34 score on a scale Interval -0.63 to -0.06	-0.27 score on a scale Interval -0.58 to 0.03

SECONDARY outcome

Timeframe: Change in GCC scales from baseline to 3 months

There are two subscales which assess Goal Concordant Care (GCC): 1. Goals of Care Conversations (GoC) (7 items scale), assessing the perceived extent to which providers have engaged the patient in the process of advance care planning (score range 0-10) and 2. Care Concordant with Preferences (CCP) (4 items scale), measuring the perceived alignment of delivered care with patient preferences (score range 0-2). Higher values represent a better outcome. There is no total score for this measure, only subscale scores apply.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=499 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=410 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Goal Concordant Care Questionnaire/ GCC (Patients) Goals of Care Conversations (GoC) scale	0.17 score on a scale Interval 0.08 to 0.26	0.35 score on a scale Interval 0.27 to 0.44
Goal Concordant Care Questionnaire/ GCC (Patients) Care Concordant with Preferences (CCP) scale	0.53 score on a scale Interval 0.35 to 0.7	0.71 score on a scale Interval 0.52 to 0.89

SECONDARY outcome

Timeframe: Change in ZBI-12 scores from baseline to 3 months

Population: Caregivers were enrolled separately. The study enrolled patients with caregivers or patients alone.

Zarit Burden Interview-12 (ZBI-12) a short, validated instrument is extensively used for palliative care research in diverse populations. It has high internal consistency, reliability and convergent validity to assess caregiver burden. Higher score reflects higher caregiver burden. The score ranges from 0- 48. This measure is for caregivers only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=296 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=240 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately.	-0.69 score on a scale Interval -1.72 to 0.33	0.73 score on a scale Interval -0.34 to 1.79

SECONDARY outcome

Timeframe: Change in caregiver QoL from baseline to 3 months

Population: Modified Intention to treatment population excludes caregivers whose patients who got a liver transplant or were transferred to Hospice within 3 months of enrollment (i.e. before completion of intervention).

PROMIS- 29 (Patient Reported Outcomes Measurement Information System) assess overall quality of life and is summarized as : Physical and Mental health summary scores. Range 0-100 for both. Higher scores reflect higher physical function but worse mental health (as higher scores reflect higher domain assessed). Here we report for caregivers only.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=296 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=240 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Caregiver Quality of Life Physical Health Summary Score	0.19 score on a scale Interval -0.43 to 0.82	0.18 score on a scale Interval -0.47 to 0.84
Caregiver Quality of Life Mental Health Summary Score	-0.10 score on a scale Interval -1.14 to 0.94	-0.49 score on a scale Interval -1.59 to 0.62

SECONDARY outcome

Timeframe: Change in GCC from baseline to 3 months

Population: Modified Intention to treatment population excludes caregivers of patients who got a liver transplant or were transferred to Hospice within 3 months of enrollment (i.e. before completion of intervention).

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=296 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=240 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Goal Concordant Care/ GCC (Caregivers) Goals of Care Conversations (GoC) scale	0.21 score on a scale Interval 0.09 to 0.32	0.45 score on a scale Interval 0.33 to 0.57
Goal Concordant Care/ GCC (Caregivers) Care Concordant with Preferences (CCP) scale	0.32 score on a scale Interval 0.06 to 0.58	0.87 score on a scale Interval 0.61 to 1.14

SECONDARY outcome

Timeframe: Survival over 12 months

Population: All enrolled patients are included in this analysis. We report the number of patients who died within 12 months from enrollment (as count of participants).

Number of Patients that Died from Baseline to 12 Month.

Outcome measures

Outcome measures
Measure	Model 1: Consultative Palliative Care n=516 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=419 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives
Mortality Over 12 Months.	84 Participants	81 Participants

Adverse Events

Model 1: Consultative Palliative Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 84 deaths

Model 2: Trained Hepatologist- Led PC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 81 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manisha Verma, MD, MPH. Director, Research

Albert Einstein Healthcare Network

Phone: 2154561026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Model 1: Consultative Palliative Care n=826 Participants Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist. Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Model 2: Trained Hepatologist- Led PC n=668 Participants A hepatologist will receive formal training to deliver Palliative Care (PC) services, and will offer palliative care to patients and caregivers following the same PC checklist as in Model 1 Palliative Care: The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include: 1. Patient/caregiver understanding of diagnosis, illness and prognosis 2. Symptom assessment and management 3. Psychosocial assessment and management 4. Distress screening and management 5. Discussion of goals of care 6. Advanced directives	Total n=1494 Participants Total of all reporting groups
Age, Continuous Patients	64 years STANDARD_DEVIATION 10 • n=516 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	62 years STANDARD_DEVIATION 10.4 • n=419 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	63 years STANDARD_DEVIATION 10.3 • n=935 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Age, Continuous Caregivers	58 years STANDARD_DEVIATION 14.2 • n=310 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	58 years STANDARD_DEVIATION 14.2 • n=249 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	58 years STANDARD_DEVIATION 14.2 • n=559 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Sex: Female, Male Patients · Female	123 Participants n=516 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	152 Participants n=419 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	275 Participants n=935 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Sex: Female, Male Patients · Male	393 Participants n=516 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	267 Participants n=419 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	660 Participants n=935 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Sex: Female, Male Caregivers (separate from patients) · Female	244 Participants n=310 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	186 Participants n=249 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	430 Participants n=559 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Sex: Female, Male Caregivers (separate from patients) · Male	66 Participants n=310 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	63 Participants n=249 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)	129 Participants n=559 Participants • This study enrolled patients and caregivers separately. Each row represents the patient and caregiver characteristics based on the actual enrollment numbers. Hence the number analyzed differes in each row and the overall represents- patients only (as patient outcomes are the primary outcomes for this trial)
Race (NIH/OMB) Patient participants · American Indian or Alaska Native	7 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	4 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	11 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · Asian	7 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	4 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	11 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · Native Hawaiian or Other Pacific Islander	0 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	1 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	1 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · Black or African American	87 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	60 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	147 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · White	409 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	332 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	741 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · More than one race	0 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	0 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	0 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Patient participants · Unknown or Not Reported	6 Participants n=516 Participants • Patients and caregiver race data are reported separately. Thank you.	18 Participants n=419 Participants • Patients and caregiver race data are reported separately. Thank you.	24 Participants n=935 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · American Indian or Alaska Native	2 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	2 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	4 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · Asian	7 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	3 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	10 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · Native Hawaiian or Other Pacific Islander	3 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	0 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	3 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · Black or African American	50 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	30 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	80 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · White	248 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	198 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	446 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · More than one race	0 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	0 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	0 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
Race (NIH/OMB) Caregiver participants · Unknown or Not Reported	0 Participants n=310 Participants • Patients and caregiver race data are reported separately. Thank you.	16 Participants n=249 Participants • Patients and caregiver race data are reported separately. Thank you.	16 Participants n=559 Participants • Patients and caregiver race data are reported separately. Thank you.
FACT-Hep total score	118.2 units on a scale STANDARD_DEVIATION 28.0 • n=516 Participants • This questionnaire is completed by patient participants only. This is a disease specific quality of life instrument which applies to patients only.	113.4 units on a scale STANDARD_DEVIATION 28.1 • n=419 Participants • This questionnaire is completed by patient participants only. This is a disease specific quality of life instrument which applies to patients only.	116.1 units on a scale STANDARD_DEVIATION 28.2 • n=935 Participants • This questionnaire is completed by patient participants only. This is a disease specific quality of life instrument which applies to patients only.
Zarit Burden Interview- 12	8.7 units on a scale STANDARD_DEVIATION 8.2 • n=310 Participants • This questionnaire is completed by caregiver participants only.	10.0 units on a scale STANDARD_DEVIATION 8.2 • n=249 Participants • This questionnaire is completed by caregiver participants only.	9.2 units on a scale STANDARD_DEVIATION 8.2 • n=559 Participants • This questionnaire is completed by caregiver participants only.