Model 2: Trained Hepatologist- led PC for Chronic Liver Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Liver Failure+1 More
Palliative Care - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is comparing two ways of introducing palliative care for people with end stage liver disease - either by having direct access to a palliative care provider, or by training a hepatologist to deliver palliative care services. The primary outcome is the change in quality of life from baseline to 3 months post enrollment, as assessed by the Functional Assessment of Cancer Therapy- Hepatobiliary. 14 Clinical Centers across the US are recruited to participate in this study.

Eligible Conditions
  • Chronic Liver Failure

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Change in ZBI-12 scores from baseline to 3 months

Month 3
Patient's symptom burden
Month 3
Patient Satisfaction
Month 3
Patient's depression severity
Month 3
Quality of Life (QOL)
Month 3
Caregiver burden

Trial Safety

Trial Design

2 Treatment Groups

Model 2: Trained Hepatologist- led PC
1 of 2
Model 1: Consultative Palliative Care
1 of 2

Active Control

1260 Total Participants · 2 Treatment Groups

Primary Treatment: Model 2: Trained Hepatologist- led PC · No Placebo Group · N/A

Model 2: Trained Hepatologist- led PC
Other
ActiveComparator Group · 1 Intervention: Palliative Care · Intervention Types: Other
Model 1: Consultative Palliative Care
Other
ActiveComparator Group · 1 Intervention: Palliative Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change in zbi-12 scores from baseline to 3 months

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
492 Previous Clinical Trials
29,826,456 Total Patients Enrolled
Albert Einstein Healthcare NetworkLead Sponsor
59 Previous Clinical Trials
1,203,220 Total Patients Enrolled
Manisha Verma, MBBS, MPHPrincipal InvestigatorAlbert Einstein Healthcare Network
1 Previous Clinical Trials
35 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References