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

June 26, 2023 updated by: University of California, San Francisco

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • Shannon Zielsdorf, MD
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Lucile Packard Children's Hospital
        • Contact:
        • Principal Investigator:
          • Noelle Ebel, MD
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Sharad Wadhwani, MD, MPH
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children'S Healthcare of Atlanta
        • Principal Investigator:
          • Nitika Gupta, MD
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Campbell, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • UPMC Children's Hospital of Pittsburgh
        • Contact:
        • Principal Investigator:
          • James Squires, MD, MS
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Medical Center Dallas
        • Contact:
        • Principal Investigator:
          • Dev Desai, MD, PhD
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Principal Investigator:
          • Evelyn Hsu, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
Time Frame: 90 Days
90 Days
Episodes of acute cellular rejection
Time Frame: 1 Year
1 Year
Ideal Outcome-3 (IO-3)
Time Frame: 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.
3 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Readmission within 90 days after transplant
Time Frame: 90 Days
90 Days
Episode of biopsy-proven acute cellular rejection within 90 days after transplant
Time Frame: 90 Days
90 Days
Episode of re-transplantation
Time Frame: 3 Years
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2020

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-29632

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe