Social & Contextual Impact on Children Undergoing Liver Transplantation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Transplantation
- Sponsor
- University of California, San Francisco
- Enrollment
- 500
- Locations
- 8
- Primary Endpoint
- Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
Time Frame: 90 Days
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.
Episodes of acute cellular rejection
Time Frame: 1 Year
Secondary Outcomes
- Episode of re-transplantation(3 Years)
- Readmission within 90 days after transplant(90 Days)
- Episode of biopsy-proven acute cellular rejection within 90 days after transplant(90 Days)