HEalth Advocate for Liver Transplant - Pilot

Pediatric ALL Clinical Trial

— HEAL-Tx Pilot  

Official title:

HEalth Advocate for Liver Transplant - Pilot

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05700799
• Other study ID #: 22-36504
• Secondary ID: K23DK132454
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Sharad Wadhwani, MD, MPH
• Phone: 510-428-3058
• Email: sharad.wadhwani[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplant; Complications
• Pediatric ALL

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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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