HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients (HEAL-Tx:ToC)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Liver Transplant; Complications
• Intervention / Treatment: Behavioral: Health Advocate

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharad Wadhwani, MD, MPH; Phone Number: 510-428-3058; Email: sharad.wadhwani@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco
      • Contact: Emily Stekol; Phone Number: 415-502-3190; Email: emily.stekol@ucsf.edu
      • Principal Investigator: Sharad Wadhwani, MD, MPH
  • Georgia
    • Atlanta, Georgia, United States, 30345
      • Not yet recruiting
      • Children's Healthcare of Atlanta
      • Principal Investigator: Nitika Gupta
      • Contact: Nitika Gupta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This is a single arm pilot intervention.	Behavioral: 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.; Other Names: Patient Navigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication adherence using MLVI	Medication level variability index (MLVI) defined as the standard deviation of at least 3 outpatient tacrolimus trough levels (binary >/=2.0 or <2.0). The investigators will assess this at study entry and again at 180 days.	Baseline and 180 days
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.	The Health Advocate will keep a detailed journal entry after each encounter and certain Health Advocate interactions will be recorded. The investigators will qualitatively analyze these journal entries and recordings to identify what functions the health advocate undertook.	180 days
A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.	The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.	180 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: American Society of Transplantation
• Investigators: Principal Investigator: Sharad Wadhwani, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Patient Navigator; Health Advocate
• Other Study ID Numbers: 23-40699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No