Health Advocate for Children After Liver Transplant

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-30

Study Completion Date

2030-08-01

Brief Summary

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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.

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Detailed Description

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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

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Pediatric Liver Transplanted Recipients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Health Advocate Intervention

The caregiver will receive 90-days of tailored health advocate intervention

Group Type EXPERIMENTAL

Health advocate

Intervention Type BEHAVIORAL

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.

Enhanced Control

The caregiver will receive a printed sheet of resources once and a follow-up call at the 45-day timepoint with a reminder of the suggested resources.

Group Type ACTIVE_COMPARATOR

Enhanced Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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HA

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No