Disparities Among Liver Transplant Patients

Individual and Structural-level Determinants Associated With Disparities Among Liver Transplant Patients

The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation.

Study Overview

• Status: Recruiting
• Conditions: End Stage Liver DIsease

Detailed Description

Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.

Aim 2. Examine interpersonal and structural factors associated with liver transplant evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).

Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant based on their demographic characteristics (e.g., race, ethnicity, SES, gender).

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Recruiting
      • Mayo Clinic Arizona
      • Contact: Adam J Milam, MD; Phone Number: 480-342-2950; Email: Milam.Adam@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects identified with end-stage liver receiving initial stage of transplant evaluation at Mayo Clinic Arizona.

Description

Inclusion Criteria:

- Patients with end-stage liver, kidney, or cardiac dysfunction.

Exclusion Criteria:

• Patients with more than one system with end stage organ dysfunction, dementia, cognitive or sensory impairment, prior solid organ transplant.
• Patients with potential medical exclusions for transplant.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Liver Transplant Patients; Subjects with end-stage liver disease and being referred for transplant evaluation will fill out questionnaires about their background, emotions, and behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver transplant waiting list	Number of subjects listed on the liver transplant waiting list	Approximately one year
Organ transplantation	Number of subject to receive an organ transplantation	Approximately one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Total number of subject alive	Approximately one year post-transplant, or until you are removed from the transplant list
Graft survival at six months	Total number of subject to have a functioning graft at six months post transplant	Six months post transplant
Graft survival at one year	Total number of subject to have a functioning graft at one year post transplant	One year post transplant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Total number of subject deaths	Approximately one year post-transplant, or until you are removed from the transplant list
Hospital length of stay	Total number of days subjects were admitted to the hospital	Approximately one year post-transplant, or until you are removed from the transplant list
ICU length of stay	Total number of days subjects were admitted to Intensive Care Unit (ICU)	Approximately one year post-transplant, or until you are removed from the transplant list
30-day readmission	Number of subjects to experience a 30-day readmission	Approximately one year post-transplant, or until you are removed from the transplant list

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Adam Milam, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Minority Health; Transplantation; Communication; Healthcare Disparities; Transplants
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: 22-008581

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No