Understanding the social factors affecting children undergoing liver transplantation
Social & Contextual Impact on Children Undergoing Liver Transplantation
This study looks at how social factors like money and education affect the health of children who are getting liver transplants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | N/A to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 8 sites (Los Angeles, California and 7 other locations) |
| Trial ID | NCT04551742 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how social determinants of health impact outcomes for children undergoing liver transplantation. Caregivers of these children will complete surveys assessing various social factors, such as economic hardship and health literacy, and participate in qualitative interviews to identify barriers and facilitators to achieving optimal health outcomes. The goal is to gain a deeper understanding of the socioeconomic inequities that may affect medication adherence, graft failure, and overall survival rates post-transplant. By integrating social needs with medical care, the study seeks to inform health system improvements.
Who should consider this trial
Good fit: Ideal candidates for this study are caregivers of children under 18 years old who are undergoing liver transplantation.
Not a fit: Patients who may not benefit from this study include those who are wards of the state or non-English/non-Spanish speakers.
Why it matters
Potential benefit: If successful, this study could lead to enhanced support systems that improve health outcomes for pediatric liver transplant patients from socioeconomically disadvantaged backgrounds.
How similar studies have performed: Other studies have shown that addressing social determinants of health can significantly improve patient outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Los Angeles, California and 7 other locations
- Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
- Lucile Packard Children's Hospital — Palo Alto, California, United States (Recruiting)
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Children's Medical Center Dallas — Dallas, Texas, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sharad Wadhwani, MD, MPH — University of California, San Francisco
- Study coordinator: Emily Stekol
- Email: emily.stekol@ucsf.edu
- Phone: 415-502-3190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.