Health Advocate for Children After Liver Transplant (HEAL-Tx:RCT)

University of California San Francisco (UCSF)

Status: Begins enrollment in 1 month

Conditions: Pediatric Liver Transplanted Recipients

Treatments: Behavioral: Health advocate; Behavioral: Enhanced Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07279350

24-41233

5K23DK132454 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Health Advocate Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Health advocate

Enhanced Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Control