Introducing Palliative Care (PC) within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Trial/ PAL LIVER study (PALliative Care for LIVER Disease)
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- STATUS
- Not Recruiting
Summary
This is a five year, two-arm multicenter cluster-randomized controlled trial (RCT) to assess the effectiveness of two Palliatice Care (PC) models for patients with end stage liver disease (ESLD).
Description
PAL-LIVER’s primary hypothesis is that patients receiving PC via the trained hepatologist-led PC (Model 2) will demonstrate a greater change in QOL (FACT-Hep scores) from baseline to 3 months, compared to Consultative led PC (Model 1). The primary outcome measure will be change in QOL (FACT-Hep total score) from baseline to 3 months. The study is powered (90%) to detect a clinically important difference in the primary outcome between the two randomized arms. A difference of a 9 point increase in FACT-hep scores is considered a minimally clinically important difference (MCID).1 The scientific premise of the primary hypothesis is that hepatologist-delivered PC will build upon an existing therapeutic relationship and expert knowledge of hepatic disease, prognosis, and disease trajectory allowing them to better individualize, and integrate PC into general hepatology care.
Details
| Condition | Liver Disease, Cirrhosis |
|---|---|
| Age | 18years - 100years |
| Clinical Study Identifier | TX10263 |
| Last Modified on | 19 February 2024 |
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