Health Advocate program for kids after liver transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HEAL-Tx is a 90-day intervention conducted at six U.S. transplant centers where families with children who recently received a liver transplant and report economic hardship are randomly assigned to either enhanced standard resources or a customized Health Advocate program. The Health Advocate helps identify local resources, coordinates appointments, and communicates family challenges to care teams, while the control group receives a printed resource list and a 45-day follow-up call. Outcomes are collected through baseline, 45-day, and 90-day interviews, with medical records reviewed at 1 and 2 years. The study uses a Type 1 hybrid design to evaluate both effectiveness and implementation in real-world settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Pittsburgh Medical Center | Children Hospital of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Sharad Wadhwani, MD, MPH — University of California, San Francisco
• Study coordinator: Bethany Reyna, BA, CCRP
• Email: Bethany.reyna@ucsf.edu
• Phone: 415-476-7748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.