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

University of California San Francisco (UCSF) logo

University of California San Francisco (UCSF)

Status

Enrolling

Conditions

Liver Transplantation
Liver Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT04551742
19-29632

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

8

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Central trial contact

Emily Stekol

Data sourced from clinicaltrials.gov

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