Clinical trial NCT06386198: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
Official title: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Transplant; Complications
Pediatric ALL
Keywords: Health Advocate
Patient Navigator
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: American Society of Transplantation
First posted: 2024-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in patient experience
timeFrame: Baseline and 180 days
Secondary outcomes:
measure: Change in medication adherence using MLVI
timeFrame: Baseline and 180 days
measure: The quality of health advocate interactions with the participants, healthcare team, and community-based resources.
timeFrame: 180 days
measure: A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention.
timeFrame: 180 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: University of California, San Francisco
name: Sharad Wadhwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: