Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD)
A legfontosabb adatok
- Hol
- Ann Arbor, Birmingham, Boston, Brooklyn, Chapel Hill, Charleston, Durham, Fresno, Gainesville, Houston, Indianapolis, Kansas City, Loma Linda, Miami, Philadelphia, Phoenix, The Bronx és West Haven (Egyesült Államok)Mind a 19 helyszín megnézése
Helyszínek itt: Egyesült Államok
- University of Michigan Medical CenterAnn Arbor, Egyesült ÁllamokNo longer taking part
- University of AlabamaBirmingham, Egyesült ÁllamokNo longer taking part
- VA BostonBoston, Egyesült ÁllamokNo longer taking part
- VA New York HarborBrooklyn, Egyesült ÁllamokNo longer taking part
- UNC Liver CenterChapel Hill, Egyesült ÁllamokNo longer taking part
- Medical University of South CarolinaCharleston, Egyesült ÁllamokNo longer taking part
- Durham V.A. Medical CenterDurham, Egyesült ÁllamokNo longer taking part
- Ucsf FresnoFresno, Egyesült ÁllamokNo longer taking part
- University of FloridaGainesville, Egyesült ÁllamokNo longer taking part
- Baylor College of MedicineHouston, Egyesült ÁllamokNo longer taking part
- Indiana UniversityIndianapolis, Egyesült ÁllamokNo longer taking part
- Kansas City VA Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- Loma Linda Unversity HealthLoma Linda, Egyesült ÁllamokNo longer taking part
- Miami VA Medical CenterMiami, Egyesült ÁllamokNo longer taking part
- Albert Einstein Medical CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- Corporal Michael J. Crescenz VA Medical CenterPhiladelphia, Egyesült ÁllamokNo longer taking part
- Banner Health- University Medical CenterPhoenix, Egyesült ÁllamokNo longer taking part
- VA BronxThe Bronx, Egyesült ÁllamokNo longer taking part
- VA West HavenWest Haven, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Albert Einstein Healthcare Network
- Azonosító
- NCT03540771
- A regiszteradat frissítve
- 2025. december 2.
- Eredeti leírás
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:A teljes eredeti leírásKevesebb
Introducing Palliative Care (PC) Within the Treatment of End Stage Liver Disease (ESLD): A Cluster Randomized Controlled Trial
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).
Primary Hypothesis: Compared to consultative PC, the trained hepatologist-led PC for ESLD patients will show superior primary outcome. In the event of nonsignificant superiority, the trained hepatologist-led PC led will show non-inferiority (NI) by ruling out a 4-point reduction (NI margin) in mean of the primary outcome as compared to the consultative PC.
Power: The study has 83.2% power to detect minimal clinically important difference (MCID) of 9 points in mean of the primary outcome between the two randomized arms. We have 79.2% power for the noninferiority hypothesis, under assumption that the trained hepatologist-led PC arm performs better than the consultative PC arm by half of the above MCID.
Setting: 19 Clinical Centers across US are recruited to participate in this study.
Qualitative nested study will interview patients, caregivers and providers to assess their experiences with participating in the palliative care trial.
Bevonási feltételek: Eligible patients were adults (≥18 years) with:; cirrhosis and a decompensation event indicative of ESLD (such as ascites, variceal bleeding or hepatic encephalopathy) within the prior 6 months, or; hepatocellular cancer (HCC) except Barcelona Stage D, or multifocal HCC (as defined by standard guidelines and confirmed by treating hepatologist); Additional inclusion criteria included English literacy and the capacity to complete study assessments.