Disparities Among Liver Transplant Patients

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981196
Collaborator
(none)
100
1
36
2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Individual and Structural-level Determinants Associated With Disparities Among Liver Transplant Patients
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2024
    Anticipated Study Completion Date :
    Sep 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Liver transplant waiting list [Approximately one year]

      Number of subjects listed on the liver transplant waiting list

    2. Organ transplantation [Approximately one year]

      Number of subject to receive an organ transplantation

    Secondary Outcome Measures

    1. Survival [Approximately one year post-transplant, or until you are removed from the transplant list]

      Total number of subject alive

    2. Graft survival at six months [Six months post transplant]

      Total number of subject to have a functioning graft at six months post transplant

    3. Graft survival at one year [One year post transplant]

      Total number of subject to have a functioning graft at one year post transplant

    Other Outcome Measures

    1. Mortality [Approximately one year post-transplant, or until you are removed from the transplant list]

      Total number of subject deaths

    2. Hospital length of stay [Approximately one year post-transplant, or until you are removed from the transplant list]

      Total number of days subjects were admitted to the hospital

    3. ICU length of stay [Approximately one year post-transplant, or until you are removed from the transplant list]

      Total number of days subjects were admitted to Intensive Care Unit (ICU)

    4. 30-day readmission [Approximately one year post-transplant, or until you are removed from the transplant list]

      Number of subjects to experience a 30-day readmission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Arizona Phoenix Arizona United States 85054

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Adam J. Milam, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05981196
    Other Study ID Numbers:
    • 22-008581
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adam J. Milam, Principal Investigator, Mayo Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2023