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

Date Added
December 18th, 2018
PRO Number
Pro00084674
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Cancer/Gastrointestinal, Liver, Pain
Summary

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, Duke has identified 19 clinical centers to participate; 8 Veterans Health Administration (VHA) systems and 11 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 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 and 3 months i.e. similar to Model 1 and follow the same visit specified agenda.

MUSC has been assigned to the Model 2 approach, "Hepatologist led Palliative Care" to be lead by Dr. Don Rockey and Dr. Heather Simpson.

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.

Institution
MUSC
Recruitment Contact
Joshua Inman
843-876-4303
inmanj@musc.edu

The reversibility of liver fibrosis after HCV eradication

Date Added
March 15th, 2018
PRO Number
Pro00076212
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

This an observational study that aims to assess the outcome of patients with advanced fibrosis and cirrhosis recurrence in patients with hepatitis C virus (HCV) infection after HCV eradication. We aim to describe this unique group of patients as well as determine whether any particular variables are significant predictors of fibrosis/cirrhosis resolution. A multivariate analysis will be conducted to determine risk factors independently related to fibrosis/cirrhosis resolution and clinical outcome.

Institution
MUSC
Recruitment Contact
Shaurya Prakash
843-860-8059
prakash@musc.edu

MUSC Pulmonary Biorepository

Date Added
December 16th, 2014
PRO Number
Pro00039387
Researcher
Charlie Strange

List of Studies


Keywords
Genetics, Liver, Lung, Pulmonary
Summary

The purpose of the MUSC Pulmonary Biorepository is to collect and store samples linked to medical and other information from individuals with pulmonary disease as well as healthy controls.

In combination with the clinical data and other approved research studies (that may recruit for and/or utilize samples of the biorepository) this sample repository will provide for uniform, longitudinal, complete and accurate data that can be organized and clinically correlated at the time of sample donation, with longitudinal testing possible as part of future study. Samples will be linked to each participant's unique ID, though will be deidentified and coded for use in future research and subsequent publications with pulmonary disease and control patients.

Institution
MUSC
Recruitment Contact
Mary Hayden
843-792-8438
blantonm@musc.edu

Comparison of 24-hours versus 72-hours of octreotide infusion along with endoscopic therapy in preventing early rebleed from esophageal varices: a multi-center, randomized clinical study

Date Added
July 16th, 2013
PRO Number
Pro00027015
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Esophagus, Liver, Vascular
Summary

The study will compare two durations of treatment with Octreotide in patients with confirmed esophageal variceal hemorrhage who have undergone successful endoscopy and possible endoscopic therapy for control of bleeding. All procedures including the treatment are the standard of care. Octreotide infusion and endoscopic therapy for esophageal variceal bleeding are not investigational.

Institution
MUSC
Recruitment Contact
Mary Hart
843-876-8439
hartmm@musc.edu



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