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Completed

NCT Number: NCT03540771

Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)

This is a comparative effectiveness study of two pragmatic models aiming to introduce palliative care for end stage liver disease patients. The 2 comparators are:

Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)

Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).

Primary Hypothesis: Compared to consultative PC, the trained hepatologist-led PC for ESLD patients will show superior primary outcome. In the event of nonsignificant superiority, the trained hepatologist-led PC led will show non-inferiority (NI) by ruling out a 4-point reduction (NI margin) in mean of the primary outcome as compared to the consultative PC.

Power: The study has 83.2% power to detect minimal clinically important difference (MCID) of 9 points in mean of the primary outcome between the two randomized arms. We have 79.2% power for the noninferiority hypothesis, under assumption that the trained hepatologist-led PC arm performs better than the consultative PC arm by half of the above MCID.

Setting: 19 Clinical Centers across US are recruited to participate in this study.

Qualitative nested study will interview patients, caregivers and providers to assess their experiences with participating in the palliative care trial.

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Key information

Conditions

End Stage Liver Disease Decompensated Cirrhosis of Liver Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

About this study

This is a two armed comparative effectiveness cluster randomized controlled trial (RCT), to assess the effectiveness of two pragmatic PC models for patients with ESLD (Consultative PC vs. Trained hepatologist led PC). To prevent bias at the level of providers, randomization will take place at the level of clinical centers; however patients will be the unit of inference. There is no standard of care arm.

Embedded within this cluster-RCT is a qualitative study will be undertaken to evaluate the patient/caregiver experiences in the two PC models, using semi structured interviews.

To execute this project, we have identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 non-VHA, Academic Medical Centers.

Comparative Approaches:

  • Consultative PC led approach (Model 1): The PC model will include: 1) routine PC consults, using a standardized checklist , 2) in-person or telehealth visits at initial, 1, 2 and 3 months. .
  • Trained hepatologist led PC (Model 2): The Hepatologist Led PC model will comprise: 1) Hepatologist training (through E Learning modules), and 2) in person or telehealth visits utilizing the same PC checklist as utilized in Model 1. The study visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

Study visits in both models could occur in-person or telehealth based, especially during in-person visit restrictions due to COVID pandemic.

Adult patients with end stage liver disease and their caregivers 18 years of age or older will be enrolled.

Primary Outcome: The change in quality of life from baseline to 3 months post enrollment as assessed by FACT-Hep (Functional Assessment of Cancer Therapy- Hepatobiliary).

Primary Hypothesis: Compared to consultative PC, the trained hepatologist-led PC for ESLD patients will show superior primary outcome. In the event of nonsignificant superiority, the trained hepatologist-led PC led will show non-inferiority (NI) by ruling out a 4-point reduction (NI margin) in mean of the primary outcome as compared to the consultative PC.

Power: The study has 83.2% power to detect clinically important difference (MCID) of 9 points in mean of the primary outcome between the two randomized arms. We have 79.2% power for the noninferiority hypothesis, under assumption that the trained hepatologist-led PC arm performs better than the consultative PC arm by half of the above MCID.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Eligible patients were adults (≥18 years) with:

  • cirrhosis and a decompensation event indicative of ESLD (such as ascites, variceal bleeding or hepatic encephalopathy) within the prior 6 months, or
  • hepatocellular cancer (HCC) except Barcelona Stage D, or multifocal HCC (as defined by standard guidelines and confirmed by treating hepatologist).

Additional inclusion criteria included English literacy and the capacity to complete study assessments.

Exclusion criteria

were hepatologist assessed life expectancy <6 months, prior liver transplantation, anticipated liver transplantation within 3 months, inability to consent, or receipt of PC within the previous three months.

Treatment and study plan

Palliative Care

Other

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:

  • Patient/caregiver understanding of diagnosis, illness and prognosis
  • Symptom assessment and management
  • Psychosocial assessment and management
  • Distress screening and management
  • Discussion of goals of care
  • Advanced directives

Primary outcomes

  1. Quality of Life (QOL)

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

    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.

Secondary outcomes

  1. Patient's Symptom Burden

    Time frame: 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.

  2. Patient's Depression Severity

    Time frame: 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.

  3. Patient Satisfaction

    Time frame: 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.

  4. Distress

    Time frame: 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.

  5. Goal Concordant Care Questionnaire/ GCC (Patients)

    Time frame: Change in GCC scales from baseline to 3 months

    There are two subscales which assess Goal Concordant Care (GCC):

    • 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
    • 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.

  6. Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately.

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

    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.

  7. Caregiver Quality of Life

    Time frame: Change in caregiver QoL from baseline to 3 months

    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.

  8. Goal Concordant Care/ GCC (Caregivers)

    Time frame: Change in GCC from baseline to 3 months

    There are two subscales which assess Goal Concordant Care (GCC):

    • 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
    • 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.

    Here we report for caregivers.

  9. Mortality Over 12 Months.

    Time frame: Survival over 12 months

    Number of Patients that Died from Baseline to 12 Month.

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial

Acronym: PAL-LIVER

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 30, 2018
Registry last updated
Dec 2, 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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