HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
- Conditions
- Liver Transplant; ComplicationsPediatric ALL
- Interventions
- Behavioral: Health Advocate
- Registration Number
- NCT06386198
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Health Advocate This is a single arm pilot intervention.
- Primary Outcome Measures
Name Time Method Changes in patient experience 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 Outcome Measures
Name Time Method Change in medication adherence using MLVI 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.
The quality of health advocate interactions with the participants, healthcare team, and community-based resources. 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.
A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention. 180 days The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.
Trial Locations
- Locations (2)
University of California San Francisco
🇺🇸San Francisco, California, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States