HEalth Advocate for Liver Transplant - Pilot (HEAL-Tx Pilot)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric ALL; Liver Transplant; Complications
• Intervention / Treatment: Behavioral: Health Advocate

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharad Wadhwani, MD, MPH; Phone Number: 510-428-3058; Email: sharad.wadhwani@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco
      • Contact: Emily Stekol; Phone Number: 415-502-3190; Email: emily.stekol@ucsf.edu
      • Principal Investigator: Sharad Wadhwani, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients under 18 years if age that have undergone liver transplantation.
2. Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This is a single arm pilot intervention.	Behavioral: Health 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.; 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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Sharad Wadhwani, MD, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Patient Navigator; Health Advocate
• Other Study ID Numbers: 22-36504; K23DK132454 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No