An interventional study of Palliative Care in End Stage Liver Disease and Decompensated Cirrhosis of Liver, sponsored by Albert Einstein Healthcare Network. Completed at 19 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Supportive care
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.
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:
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.
267 studies on the registry are indexed under End Stage Liver Disease; 61 are open to participants now.
This study's enrollment of 1,494 is above the median of 70 across 153 interventional studies indexed under End Stage Liver Disease.
Browse End Stage Liver Disease studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Eligible patients were adults (≥18 years) with:
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.
Direct access to Palliative Care provider, who will offer palliative care to patients and caregivers, as guided by a standard PC (palliative care) checklist.
Other: Palliative Care
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
Other: 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)
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.
Time frame: Mean change in FACT-Hep total score from baseline to 3 months
Patient's Symptom Burden
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.
Time frame: Change in ESAS total score from baseline to 3 months
Patient's Depression Severity
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.
Time frame: Change in PHQ-9 scores from baseline to 3 months
Patient Satisfaction
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.
Time frame: Change in FAMCARE-P scores from baseline to 3 months.
Distress
Distress thermometer (DT) ranks level of distress from 0- 10, Higher scores reflect higher distress. This is for patients only.
Time frame: Change in Distress from baseline to 3 months
Goal Concordant Care Questionnaire/ GCC (Patients)
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.
Time frame: Change in GCC scales from baseline to 3 months
Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately.
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.
Time frame: Change in ZBI-12 scores from baseline to 3 months
Caregiver Quality of Life
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.
Time frame: Change in caregiver QoL from baseline to 3 months
Goal Concordant Care/ GCC (Caregivers)
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. Here we report for caregivers.
Time frame: Change in GCC from baseline to 3 months
Mortality Over 12 Months.
Number of Patients that Died from Baseline to 12 Month.
Time frame: Survival over 12 months
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.
| Milestone | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Started | 826 | 668 |
| Completed | 558 | 456 |
| Not completed | 268 | 212 |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Quality of Life (QOL) | 7.02 (4.34 to 9.71) | 8.01 (5.38 to 10.65) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Patient's Symptom Burden | -5.31 (-7.59 to -3.02) | -7.52 (-9.89 to -5.15) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Patient's Depression Severity | -0.90 (-1.49 to -0.31) | -1.18 (-1.78 to -0.57) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Patient Satisfaction | 0.91 (-0.15 to 1.96) | 3.37 (2.24 to 4.49) |
Distress thermometer (DT) ranks level of distress from 0- 10, Higher scores reflect higher distress. This is for patients only.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Distress | -0.34 (-0.63 to -0.06) | -0.27 (-0.58 to 0.03) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Goals of Care Conversations (GoC) scale | 0.17 (0.08 to 0.26) | 0.35 (0.27 to 0.44) |
| Care Concordant with Preferences (CCP) scale | 0.53 (0.35 to 0.70) | 0.71 (0.52 to 0.89) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Caregiver Burden (Completed by the Caregivers of Patients Who Were Enrolled as a Dyad). Caregivers Were Consented Separately. | -0.69 (-1.72 to 0.33) | 0.73 (-0.34 to 1.79) |
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.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Physical Health Summary Score | 0.19 (-0.43 to 0.82) | 0.18 (-0.47 to 0.84) |
| Mental Health Summary Score | -0.10 (-1.14 to 0.94) | -0.49 (-1.59 to 0.62) |
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. Here we report for caregivers.
| score on a scale | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Goals of Care Conversations (GoC) scale | 0.21 (0.09 to 0.32) | 0.45 (0.33 to 0.57) |
| Care Concordant with Preferences (CCP) scale | 0.32 (0.06 to 0.58) | 0.87 (0.61 to 1.14) |
Number of Patients that Died from Baseline to 12 Month.
| Participants | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC |
|---|---|---|
| Mortality Over 12 Months. | 84 | 81 |
Collected over All patients were followed for 1 year from enrollment. All-Cause Mortality, Serious Adverse Events and Other Adverse Events data were monitored for patients only.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Model 1: Consultative Palliative Care | 84/516 (16.3%) | 0/516 (0%) | 0/516 (0%) |
| Model 2: Trained Hepatologist- Led PC | 81/419 (19.3%) | 0/419 (0%) | 0/419 (0%) |
The total study participants (1494) includes 935 patients (516 in Consultative PC and 419 in Trained Hepatologist led PC) and 559 caregivers (310 in Consultative PC and 249 in Trained Hepatologist led PC)
| Age, Continuous(years) | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC | Total |
|---|---|---|---|
| Patients | 64 ± 10 | 62 ± 10.4 | 63 ± 10.3 |
| Caregivers | 58 ± 14.2 | 58 ± 14.2 | 58 ± 14.2 |
| Sex: Female, Male(Participants) | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC | Total |
|---|---|---|---|
| Patients — Female | 123 | 152 | 275 |
| Patients — Male | 393 | 267 | 660 |
| Caregivers (separate from patients) — Female | 244 | 186 | 430 |
| Caregivers (separate from patients) — Male | 66 | 63 | 129 |
| Race (NIH/OMB)(Participants) | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC | Total |
|---|---|---|---|
| Patient participants — American Indian or Alaska Native | 7 | 4 | 11 |
| Patient participants — Asian | 7 | 4 | 11 |
| Patient participants — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Patient participants — Black or African American | 87 | 60 | 147 |
| Patient participants — White | 409 | 332 | 741 |
| Patient participants — More than one race | 0 | 0 | 0 |
| Patient participants — Unknown or Not Reported | 6 | 18 | 24 |
| Caregiver participants — American Indian or Alaska Native | 2 | 2 | 4 |
| Caregiver participants — Asian | 7 | 3 | 10 |
| Caregiver participants — Native Hawaiian or Other Pacific Islander | 3 | 0 | 3 |
| Caregiver participants — Black or African American | 50 | 30 | 80 |
| Caregiver participants — White | 248 | 198 | 446 |
| Caregiver participants — More than one race | 0 | 0 | 0 |
| Caregiver participants — Unknown or Not Reported | 0 | 16 | 16 |
| FACT-Hep total score(units on a scale) | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC | Total |
|---|---|---|---|
| Mean | 118.2 ± 28.0 | 113.4 ± 28.1 | 116.1 ± 28.2 |
| Zarit Burden Interview- 12(units on a scale) | Model 1: Consultative Palliative Care | Model 2: Trained Hepatologist- Led PC | Total |
|---|---|---|---|
| Mean | 8.7 ± 8.2 | 10.0 ± 8.2 | 9.2 ± 8.2 |
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