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Social & Contextual Impact on Children Undergoing Liver Transplantation

Social & Contextual Impact on Children Undergoing Liver Transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04551742
Acronym
SOCIAL-TX
Enrollment
500
Registered
2020-09-16
Start date
2020-09-16
Completion date
2026-04-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases, Liver Transplantation

Keywords

Pediatric, Health services research, Social determinants of health

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.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization90 Days
Episodes of acute cellular rejection1 Year
Ideal Outcome-3 (IO-3)3 YearsThe 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

MeasureTime frame
Readmission within 90 days after transplant90 Days
Episode of biopsy-proven acute cellular rejection within 90 days after transplant90 Days
Episode of re-transplantation3 Years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSharad Wadhwani, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026