ACTIVE_NOT_RECRUITING

Social & Contextual Impact on Children Undergoing Liver Transplantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Social & Contextual Impact on Children Undergoing Liver Transplantation

Quick Facts

Study Start:2020-09-16
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04551742

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children \<18 years of age at the time of transplant
  2. * Undergoing liver transplantation
  3. * Guardian's consent, child assent (in accordance with each institution's IRB policies)
  4. * Consents to enrollment in SPLIT
  1. * Caregiver unwilling or unable to complete the survey
  2. * 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
  3. * Non-English, non-Spanish speakers
  4. * Non-US residents
  5. * Declined participation in SPLIT
  6. * Participants who have completed the questionnaire OR
  7. * Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)

Contacts and Locations

Principal Investigator

Sharad Wadhwani, MD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

Children's Hospital Los Angeles
Los Angeles, California, 90027
United States
Lucile Packard Children's Hospital
Palo Alto, California, 94304
United States
University of California San Francisco
San Francisco, California, 94158
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
United States
Children's Medical Center Dallas
Dallas, Texas, 75235
United States
Seattle Children's Hospital
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Sharad Wadhwani, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-16
Study Completion Date2026-04

Study Record Updates

Study Start Date2020-09-16
Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

  • Pediatric
  • Health services research
  • Social determinants of health

Additional Relevant MeSH Terms

  • Liver Transplantation
  • Liver Diseases