Clinical trial NCT04551742: Social & Contextual Impact on Children Undergoing Liver Transplantation
Official title: Social & Contextual Impact on Children Undergoing Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplantation
Liver Diseases
Keywords: Pediatric
Health services research
Social determinants of health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 500
Sex: ALL
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caregivers or parents of children undergoing liver transplantation Healthcare professionals caring for children undergoing liver transplantation

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.


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)

Primary outcomes:
measure: Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
timeFrame: 90 Days
measure: Episodes of acute cellular rejection
timeFrame: 1 Year
measure: Ideal Outcome-3 (IO-3)
timeFrame: 3 Years
Secondary outcomes:
measure: Readmission within 90 days after transplant
timeFrame: 90 Days
measure: Episode of biopsy-proven acute cellular rejection within 90 days after transplant
timeFrame: 90 Days
measure: Episode of re-transplantation
timeFrame: 3 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Sharad Wadhwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: