Health Advocate for Children After Liver Transplant

NCT07279350 | Not Yet Recruiting

• 2 other identifiers: 24-412335K23DK132454
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Liver Transplanted Recipients

Keywords

pediatric liver transplantation

Outcome Measures

Primary Outcomes (1)

• Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots.

  After the perioperative period, it is an objective outcome closely linked with poor adherence/challenges with self-management. Investigators found strong associations between material economic hardship and TCMR episodes of TCMR increase risks of graft failure/death post-transplant and early TCMR increases risk of late TCMR and vulnerability to infections. All analyses will be intention-to-treat. Investigators will use Kaplan-Meier plots to descriptively compare survival distributions of the primary outcome (TCMR) by trial arm. We will compare time-to-TCMR between treatment arms using Cox regression. For participants recruited in years 1 \& 2 of the study period, we will collect 2 years of follow-up data. For participants recruited in year 3, we will apply administrative censoring after 1 year of follow up data.

  Through study completion, an average of 1 year up to 2 years.

Secondary Outcomes (7)

• Measurement of incidence of Medication Level Variability Index >2.0 using generalized linear mixed effect models.

  Through study completion, an average of one year up to 2 years.

• Change in Parent-Reported Social Needs Score From Baseline to 90 Days (SIREN-Informed PRO Measure)

  Baseline and 90-days post enrollment

• Liver inflammation (ALT or GGT >50) and overimmunosuppression (positive EBV or CMV PCR) at years 1 and 2 using linear mixed effects models.

  An average of 1 year up to 2 years.

• Parent-Reported Social Service Utilization (Count of Services Received)

  90-days post enrollment

• Change in Parent-Reported Social Service Utilization From Baseline to 90 Days

  Baseline and 90 days post-enrollment

Other Outcomes (1)

• Implementation outcomes using the RE-AIM model.

  Baseline, Day-45 (treatment arm only), 90-day timepoints

Study Arms (2)

Health Advocate Intervention

EXPERIMENTAL

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

Behavioral: Health advocate

Enhanced Control

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Control

Interventions

Health advocate 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.

Also known as: HA

Health Advocate Intervention

Enhanced Control 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.

Enhanced Control

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 may not qualify if:

• Patient has severe cognitive impairment.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (3)

• Monette S, Seguin L, Gauvin L, Nikiema B. Validation of a measure of maternal perception of the child's health status. Child Care Health Dev. 2007 Jul;33(4):472-81. doi: 10.1111/j.1365-2214.2006.00713.x.

  PMID: 17584404 BACKGROUND

• Minkovitz CS, O'Campo PJ, Chen YH, Grason HA. Associations between maternal and child health status and patterns of medical care use. Ambul Pediatr. 2002 Mar-Apr;2(2):85-92. doi: 10.1367/1539-4409(2002)0022.0.co;2.

  PMID: 11926838 BACKGROUND

• Witte J, Mehlis K, Surmann B, Lingnau R, Damm O, Greiner W, Winkler EC. Methods for measuring financial toxicity after cancer diagnosis and treatment: a systematic review and its implications. Ann Oncol. 2019 Jul 1;30(7):1061-1070. doi: 10.1093/annonc/mdz140.

  PMID: 31046080 BACKGROUND

Related Links

• Related Info

Study Officials

• Sharad Wadhwani, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Reyna, BA, CCRP

CONTACT

415-476-7748; Bethany.reyna@ucsf.edu

Andrea Huerta

CONTACT

andrea.huerta2@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: December 12, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)