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(352) 733-0111

7089 PAL-LIVER

  • Status
    Accepting Candidates
  • Age
    18 Years - 120 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title 7089 PAL-LIVER Introducing Palliative Care (PC) within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
Protocol number OCR35342
ClinicalTrials.gov ID NCT03540771
Phase N/A

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

Lead researcher

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    1

    Contact the research team

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    Primary contact

  2. Step
    2

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  4. Step
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