Social & Contextual Impact on Children Undergoing Liver Transplantation

Liver Transplantation Clinical Trial

— SOCIAL-TX  

Official title:

Social & Contextual Impact on Children Undergoing Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551742
• Other study ID #: 19-29632
• Status: Recruiting
• Start date: September 16, 2020
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Emily Stekol
• Phone: 415-502-3190
• Email: emily.stekol[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Liver Diseases
• Liver Transplantation

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Lucile Packard Children's Hospital	Palo Alto	California
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of California San Francisco	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization		90 Days
Primary	Episodes of acute cellular rejection		1 Year
Primary	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	Readmission within 90 days after transplant		90 Days
Secondary	Episode of biopsy-proven acute cellular rejection within 90 days after transplant		90 Days
Secondary	Episode of re-transplantation		3 Years