Summary

Eligibility
for people ages 0-18 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Sharad Wadhwani, MD, MPH (ucsf)
Headshot of Sharad Wadhwani
Sharad Wadhwani

Description

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.

Official Title

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

Details

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.

Keywords

Pediatric Liver Transplanted Recipients, pediatric liver transplantation, Health advocate

Eligibility

You can join if…

Open to people ages 0-18

  • Patient <18 years old at the time of liver transplant
  • Received a liver transplant within past 90 days
  • Family endorses material economic hardship on 10-questions Accountable Healthcare Communities screening tool.
  • Will receive follow-up care for at least 2 years
  • Family can read or write English or Spanish
  • A Legally Authorized Representative (LAR) can provide consent, and for children (12-17 years of age, the child is willing/able to provide assent.)
  • Family has a working phone and smartphone device capable of receiving calls or virtual visits via Zoom.

You CAN'T join if...

  • Patient has severe cognitive impairment.
  • 18 years of age or older at the time of consent
  • Patient unwilling or unable to consent/participate
  • Patient 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 as ICFs, HIPAA authorization form, surveys, and interviews will only be available in these 2 languages. Languages besides English and Spanish are excluded from this study.

Location

  • University of California, San Francisco
    San Francisco California 94158 United States

Lead Scientist at University of California Health

  • Sharad Wadhwani, MD, MPH (ucsf)
    Dr. Wadhwani is a practicing pediatric general/transplant hepatologist who specializes in caring for children across the entire spectrum of liver disease, from diagnosis to transplant. Dr. Wadhwani is a clinical investigator with an active research program dedicated to improving the lives of children undergoing liver transplant.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Related Info
ID
NCT07279350
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated