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NCT Number: NCT05700799

HEalth Advocate for Liver Transplant - Pilot

The Health Advocate for Liver Transplant (HEAL-Tx) 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. 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 pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.

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Key information

Conditions

Liver Transplant; Complications Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Location status: Recruiting

Location contact

Emily Stekol

CONTACT

[email protected]

415-502-3190

Sharad Wadhwani, MD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients under 18 years if age that have undergone liver transplantation.
  • Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.
  • Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.
  • Patient and/or caregiver felt to be a good fit for this pilot by transplant team.

Exclusion criteria

  • Caregiver unwilling or unable to complete the survey.
  • Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.
  • Non-English, non-Spanish speakers.
  • Non-US residents.
  • Greater than 18 years of age at the time of enrollment.

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 caregiver experience

    Time frame: Baseline and 90 days

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

Secondary outcomes

  1. Change in medication adherence using MLVI

    Time frame: Baseline, 90 days, and 180 days

    Medication level variability index (MLVI) defined as the standard deviation of 3 outpatient tacrolimus trough levels (binary >/=2.0 or <2.0). The investigators will assess this at study entry, intervention completion, and 6 months after study entry.

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

    Time frame: 90 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 caregiver and healthcare provider satisfaction with the Health Advocate intervention.

    Time frame: 90 days

    The investigators will conduct in-depth interviews with the caregiver 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

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: HEAL-Tx Pilot

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2023
Registry last updated
Aug 17, 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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