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

NCT ID: NCT06386198

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-03
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

This is a single arm pilot intervention.

Group Type: EXPERIMENTAL

Health Advocate

Intervention Type: 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.

Interventions

Health Advocate

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient Navigator

Eligibility Criteria

Inclusion Criteria

1. Patient has received a liver transplant >1 year ago

2. Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.

3. Patient has an unmet social risk (e.g., food insecurity) or MLVI >/= 2.0.

4. Patient will be transferred to adult transplant team in <6 months.

5. Patient can read and write English or Spanish

6. Patient is between 18-25 years old and can provide informed consent.

7. Patient has a working phone and smart device capable of video and/or audio virtual visits via Zoom.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Transplantation

UNKNOWN

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharad Wadhwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Sharad Wadhwani, MD, MPH

Role: CONTACT

sharad.wadhwani@ucsf.edu

510-428-3058

Facility Contacts

Emily Stekol

Role: primary

emily.stekol@ucsf.edu

415-502-3190

Nitika Gupta

Role: primary

Other Identifiers

23-40699

Identifier Type: -

Identifier Source: org_study_id