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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03540771
Recruitment Status : Recruiting
First Posted : May 30, 2018
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Victor Navarro, Albert Einstein Healthcare Network

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
End Stage Liver Disease Other: Palliative Care Not Applicable

Detailed Description:

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:

  1. 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. .
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
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

Active Comparator: 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
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




Primary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: Change in QOL 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. The scores range from 0 to 160. Higher scores reflect better QOL.


Secondary Outcome Measures :
  1. Patient's symptom burden [ Time Frame: Change in ESAS scores from baseline to 3 months ]
    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.

  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.

  3. Caregiver burden [ 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. 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.

  4. 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 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03540771


Contacts
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Contact: Manisha Verma, MBBS, MPH 2154561026 VermaM@einstein.edu

Locations
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United States, California
Loma Linda Unversity Health Recruiting
Loma Linda, California, United States, 92354
Contact: Mina Rakoski, MD         
United States, Connecticut
VA West Haven Recruiting
West Haven, Connecticut, United States, 06516
Contact: Simona Jakab, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Eric Orman, MD         
United States, Massachusetts
VA Boston Recruiting
Boston, Massachusetts, United States, 02130
Contact: Gyorgy Baffy, MD         
United States, Michigan
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Elliott Tapper, MD         
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: Prashant Pandya, MD         
United States, New York
VA Bronx Recruiting
Bronx, New York, United States, 10468
Contact: Kristel Hunt, MD         
VA New York Harbor Recruiting
Brooklyn, New York, United States, 11209
Contact: Ayse Ayatman, MD         
United States, North Carolina
UNC Liver Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Sidney Baritt, MD         
Durham V.A. Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Steve Choi, MD         
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marina Serper, MD         
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Richard Kalman, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Donald Rockey, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Maya Balakrishnan, MD         
Sponsors and Collaborators
Albert Einstein Healthcare Network
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Manisha Verma, MBBS, MPH Albert Einstein Healthcare Network

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Victor Navarro, Chairman, Digestive Diseases and Transplantation, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT03540771    
Other Study ID Numbers: Pro00092149
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Victor Navarro, Albert Einstein Healthcare Network:
palliative care
hepatology
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency