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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patient has significant cognitive impairment.

Does not meet age criteria

Patient is a ward of the state.

Non-English, non-Spanish speakers.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 180 days

Secondary outcomes

1

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.

Time frame
Baseline and 180 days
2

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.

Time frame
180 days
3

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.

Time frame
180 days

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

American Society of Transplantation

Collaborator