NCT07279350

Health Advocate for Children After Liver Transplant

Health Advocate for Children After Liver Transplant: A Hybrid Implementation Effectiveness RCT

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The HEAL-Tx is a 90-day intervention, in which a Health Advocate works with eligible families to identify and apply for community-based resources, alert healthcare providers to challenges the family is encountering, and guide health system navigation (e.g., coordinating appointments). Families in the control arm will receive a printed handout that provides contact information for local community-based resources. Families in the treatment arm will receive HEAL-Tx.

Detailed description

HEAL-Tx trial is a Type 1 hybrid effectiveness-implementation trial across 6 U.S. transplant centers (UCSF, Seattle Children's Hospital, Stanford University, Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital of Colorado.) Children/families will be screened for material economic hardship as part of standard of care during their transplant hospitalization using the 10-question Accountable Healthcare Communities tool. Families who report material economic hardship will be approached for study participation, and those who consent will be randomized to either the control or treatment arm. Participants in the control arm will receive enhanced standard of care: they will receive a printed handout with a list of resources specific to their hardship and their home ZIP code. They will also receive a follow-up call at 45-days with a reminder of the suggested resources. Participants in the treatment arm will receive a customized 90-day Health Advocate intervention. Both the treatment and control arm group will complete a baseline interview and a close-out 90-day interview to assess outcomes and experiences with the intervention. The treatment arm will have one additional interview at the 45-day timepoint. Once both arms complete treatment, they will have data extracted from their medical records at the 1, and 2-year timepoint.

Conditions

• Pediatric Liver Transplanted Recipients

Interventions

Type	Name	Description
BEHAVIORAL	Health advocate	The health advocate is a trained individual who is not a part of the medical team. They work directly with the caregivers of patients who have received a liver transplantation to assist them with navigating the healthcare system, find resources, and relay any concerns to their medical team. They work with an assigned family for 90-days and tailor their intervention to meet the families social needs.
BEHAVIORAL	Enhanced Control	Caregivers in the control arm will receive enhanced standard of care: they will be given a handout with a list of resources specific to their hardship and their home ZIP code. They will receive a follow-up call at 45 days with a reminder of the suggested resources.

Timeline

• Start date: 2026-03-30
• Primary completion: 2030-08-01
• Completion: 2030-08-01
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

1 site across 1 country: United States