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NCT Number: NCT06386198

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

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.

Recruiting

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

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.

Other names: Patient Navigator

Primary outcomes

  1. Changes in patient experience

    Time frame: Baseline and 180 days

    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.

Secondary outcomes

  1. Change in medication adherence using MLVI

    Time frame: Baseline and 180 days

    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.

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

    Time frame: 180 days

    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.

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

    Time frame: 180 days

    The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharad Wadhwani, MD, MPH

CONTACT

[email protected]

510-428-3058

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • American Society of Transplantation

Registry information

Acronym: HEAL-Tx:ToC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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