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

End Stage Liver Disease Clinical Trial

— PAL-LIVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03540771
• Other study ID #: Pro00092149
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2022
• Source: Albert Einstein Healthcare Network
• Contact: Manisha Verma, MBBS, MPH
• Phone: 2154561026
• Email: VermaM[@]einstein.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: May 31, 2025
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Liver Disease
• Liver Diseases

Intervention

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: 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

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Alabama	Birmingham	Alabama
United States	VA Boston	Boston	Massachusetts
United States	VA Bronx	Bronx	New York
United States	VA New York Harbor	Brooklyn	New York
United States	UNC Liver Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Durham V.A. Medical Center	Durham	North Carolina
United States	UCSF Fresno	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Loma Linda Unversity Health	Loma Linda	California
United States	Miami VA Medical Center	Miami	Florida
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania
United States	Banner Health- University Medical Center	Phoenix	Arizona
United States	VA West Haven	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (4)

DeNofrio JC, Verma M, Kosinski AS, Navarro V, Taddei TH, Volk ML, Bakitas M, Ramchandran K. Palliative Care Always: Hepatology-Virtual Primary Palliative Care Training for Hepatologists. Hepatol Commun. 2022 Apr;6(4):920-930. doi: 10.1002/hep4.1849. Epub 2021 Oct 31. — View Citation

Verma M, Bakitas MA. Creating Effective Models for Delivering Palliative Care in Advanced Liver Disease. Curr Hepatol Rep. 2021;20(2):43-52. doi: 10.1007/s11901-021-00562-0. Epub 2021 Apr 10. Review. — View Citation

Verma M, Kosinski AS, Volk ML, Taddei T, Ramchandran K, Bakitas M, Green K, Green L, Navarro V. Introducing Palliative Care within the Treatment of End-Stage Liver Disease: The Study Protocol of a Cluster Randomized Controlled Trial. J Palliat Med. 2019 Sep;22(S1):34-43. doi: 10.1089/jpm.2019.0121. Review. — View Citation

Verma M, Tapper EB, Singal AG, Navarro V. Nonhospice Palliative Care Within the Treatment of End-Stage Liver Disease. Hepatology. 2020 Jun;71(6):2149-2159. doi: 10.1002/hep.31226. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.

External Links

•   PCORI web release
•   Study Protocol