HEalth Advocate for Liver Transplant - Pilot

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
HEalth Advocate for Liver Transplant - Pilot

Conditions
-----------------
Liver Transplant; Complications, Pediatric ALL

Intervention / Treatment
-----------------
* Behavioral: Health Advocate


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This is a single arm pilot intervention. | Behavioral: Health Advocate<br>* 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.<br>* Other names: Patient Navigator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in caregiver experience | 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. | Baseline and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication adherence using MLVI | 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. | Baseline, 90 days, and 180 days | 
| 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. | 90 days | 
| A qualitative assessment of caregiver and healthcare provider satisfaction with the Health Advocate intervention. | The investigators will conduct in-depth interviews with the caregiver participant and clinical team members to assess overall satisfaction with the intervention. | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Health Advocate, Patient Navigator