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

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: Active, not recruiting
• Conditions: Liver Diseases; Liver Transplantation

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • Palo Alto, California, United States, 94304
      • Lucile Packard Children's Hospital
    • San Francisco, California, United States, 94158
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Children's Healthcare of Atlanta
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • UPMC Children's Hospital of Pittsburgh
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

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

How is the study designed?

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		90 Days
Episodes of acute cellular rejection		1 Year
Ideal Outcome-3 (IO-3)	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	90 Days
Episode of biopsy-proven acute cellular rejection within 90 days after transplant	90 Days
Episode of re-transplantation	3 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

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): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pediatric; Health services research; Social determinants of health
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• 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