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SOCIAL-TX: Social & Contextual Impact on Children Undergoing Liver Transplantation

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04551742
Collaborator
(none)
500
Enrollment
9
Locations
50.5
Anticipated Duration (Months)
55.6
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.

Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Social & Contextual Impact on Children Undergoing Liver Transplantation
    Actual Study Start Date :
    Sep 16, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization [90 Days]

    2. Episodes of acute cellular rejection [1 Year]

    3. Ideal Outcome-3 (IO-3) [3 Years]

      The ideal outcome measure is a composite measure of morbidity after transplant defined as alive, ALT and GGT <50, normal GFR, no non-liver transplants, no cytopenias, and no PTLD.

    Secondary Outcome Measures

    1. Readmission within 90 days after transplant [90 Days]

    2. Episode of biopsy-proven acute cellular rejection within 90 days after transplant [90 Days]

    3. Episode of re-transplantation [3 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Caregivers/parents of children with the following criteria will be approached for inclusion in this study:

    • Children <18 years of age at the time of transplant

    • Undergoing liver transplantation

    • Guardian's consent, child assent (in accordance with each institution's IRB policies)

    • Consents to enrollment in SPLIT

    Exclusion Criteria:
    Caregivers/parents of children undergoing liver transplantation will be excluded it:

    • Caregiver unwilling or unable to complete the survey

    • Child is a ward of the state (e.g., foster care) since present circumstances may not be reflective of child's past or future circumstances

    • Non-English, non-Spanish speakers

    • Non-US residents

    • Declined participation in SPLIT

    Inclusion Criteria for Interview Portion of the Study:

    • Participants who have completed the questionnaire OR

    • Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital Los Angeles Los Angeles California United States 90027
    2 Lucile Packard Children's Hospital Palo Alto California United States 94304
    3 University of California San Francisco San Francisco California United States 94158
    4 Children's Healthcare of Atlanta Atlanta Georgia United States 30329
    5 Columbia University New York New York United States 10032
    6 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
    7 UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15224
    8 Children's Medical Center Dallas Dallas Texas United States 75235
    9 Seattle Children's Hospital Seattle Washington United States 98105

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Sharad Wadhwani, MD, MPH, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT04551742
    Other Study ID Numbers:
    • 19-29632
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    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 University of California, San Francisco
    Pediatric
    Health services research
    Social determinants of health
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jun 23, 2022