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

Pediatric ALL Clinical Trial

— HEAL-Tx:ToC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386198
• Other study ID #: 23-40699
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Sharad Wadhwani, MD, MPH
• Phone: 510-428-3058
• Email: sharad.wadhwani[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Pediatric ALL

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.

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	American Society of Transplantation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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