HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients

NCT06386198 | Recruiting

• 1 other identifier: 23-40699
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent/young adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.

Conditions

Liver Transplant; Complications; Pediatric ALL

Keywords

Health Advocate; Patient Navigator

Outcome Measures

Primary Outcomes (1)

• Changes in patient experience

  The investigators will administer a survey of patient experience at study enrollment and at the end of the intervention to assess for changes in patient experience with the transplant team. These questions will focus on experiences receiving transplant care, experiences discussing social needs with the transplant team, and overall subjective assessment of the transplant recipient's overall health.

  Baseline and 180 days

Secondary Outcomes (3)

• Change in medication adherence using MLVI

  Baseline and 180 days

• The quality of health advocate interactions with the participants, healthcare team, and community-based resources.

  180 days

• A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.

  180 days

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single arm pilot intervention.

Behavioral: Health Advocate

Interventions

Health Advocate BEHAVIORAL

The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination.

Also known as: Patient Navigator

Intervention

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient has received a liver transplant \>1 year ago
• Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.
• Patient has an unmet social risk (e.g., food insecurity) or MLVI \>/= 2.0.
• Patient will be transferred to adult transplant team in \<6 months.
• Patient can read and write English or Spanish
• Patient is between 18-25 years old and can provide informed consent.
• Patient has a working phone and smart device capable of video and/or audio virtual visits via Zoom.

You may not qualify if:

• Patient has significant cognitive impairment.
• Does not meet age criteria
• Patient is a ward of the state.
• Non-English, non-Spanish speakers.
• Non-US residents.

Sponsors & Collaborators

• University of California, San Francisco: lead
• American Society of Transplantation: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, 30345, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sharad Wadhwani, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharad Wadhwani, MD, MPH

CONTACT

510-428-3058; sharad.wadhwani@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: March 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)