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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06386198
Acronym
HEAL-Tx:ToC
Enrollment
20
Registered
2024-04-26
Start date
2024-03-03
Completion date
2030-06-30
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications

Keywords

Health Advocate, Patient Navigator

Brief 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.

Interventions

BEHAVIORALHealth 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
American Society of Transplantation
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in patient experienceBaseline and 180 daysThe 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

MeasureTime frameDescription
Change in medication adherence using MLVIBaseline and 180 daysMedication 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.
The quality of health advocate interactions with the participants, healthcare team, and community-based resources.180 daysThe 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.
A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.180 daysThe investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.

Countries

United States

Contacts

CONTACTSharad Wadhwani, MD, MPH
sharad.wadhwani@ucsf.edu510-428-3058
PRINCIPAL_INVESTIGATORSharad Wadhwani, MD, MPH

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026