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

Study Overview
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Brief Summary
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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). 14 Clinical Centers across US are recruited to participate in this study.

Detailed Description
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This is a two armed multicenter 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. Parallel to this cluster-RCT, 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 14 clinical centers to participate; 7 Veterans Health Administration (VHA) systems and 7 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 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 visits utilizing the same PC checklist as utilized in Model 1. The in-person visits will occur at initial, 1, 2 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda. Adult patients 18 years of age or older will be enrolled. With 14 clinical centers in different geographic locations and diversity in race/ ethnicity, 1260 patient/ caregiver dyads will be enrolled.

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

Conditions
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End Stage Liver Disease

Intervention / Treatment
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* Other: Palliative Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with new onset or ongoing complications of End Stage Liver Disease including Hepatocellular Cancer (HCC) (irrespective of their transplant status), with a caregiver willing to participate. Exclusion Criteria: MELD> 30 or Expected life expectancy of less than 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Model 1: Consultative Palliative Care (i.e. direct access to Palliative Care provider), versus Model 2: Trained Hepatologist- led PC intervention (i.e. a hepatologist will receive formal training to deliver Palliative Care services)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Model 1: Consultative Palliative Care<br>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<br>* 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<br>|
| Active Comparator: Model 2: Trained Hepatologist- led PC<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. The scores range from 0 to 160. Higher scores reflect better QOL. | Change in QOL from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's symptom burden | Edmonton Symptom Assessment Scale (ESAS) will evaluate 11 symptoms (pain, fatigue, myalgia, sexual dysfunction, anxiety, sleep disturbance, appetite, well-being, dyspnea, pruritus and ability to think clearly) on a 10-point scale, where 0 is no symptom and 10 is the maximum severity of symptom. | Change in ESAS scores 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. | Change in PHQ-9 scores from baseline to 3 months | 
| Caregiver burden | 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. It has high correlation [Rho (95% CI) 0.95 (0.92- 0.96)] with the long form, and is less burdensome. The sensitivity and specificity is 92% and 94% with a cutoff score of 12. | Change in ZBI-12 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 measures the availability of care, symptom management, psychosocial care and information sharing including support for decision making. It consists of 13 questions, with Likert scale response options with high reliability. Higher scores imply better satisfaction from the care received. | Change in FAMCARE-P scores from baseline to 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palliative care, hepatology