Social & Contextual Impact on Children Undergoing Liver Transplantation

NCT04551742 | Active Not Recruiting

• 1 other identifier: 19-29632
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 8

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.

Conditions

Liver Diseases; Liver Transplantation

Keywords

Pediatric; Health services research; Social determinants of health

Outcome Measures

Primary Outcomes (3)

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

  90 Days

• Episodes of acute cellular rejection

  1 Year

• Ideal Outcome-3 (IO-3)

  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.

  3 Years

Secondary Outcomes (3)

• Readmission within 90 days after transplant

  90 Days

• Episode of biopsy-proven acute cellular rejection within 90 days after transplant

  90 Days

• Episode of re-transplantation

  3 Years

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (8)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Sharad Wadhwani, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 16, 2020
• Study Start: September 16, 2020
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)