Active — Not RecruitingNot Applicable

Social & Contextual Impact on Children Undergoing Liver Transplantation

United States500 participantsStarted 2020-09-16

Plain-language 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.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization

Timeframe: 90 Days

Episodes of acute cellular rejection

Timeframe: 1 Year

Ideal Outcome-3 (IO-3)

Timeframe: 3 Years

Trial details

NCT IDNCT04551742

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Liver Transplantation trials