HEAL-Tx Pilot: HEalth Advocate for Liver Transplant - Pilot

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05700799

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

Enrollment

Location

Arm

29.3

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications Pediatric ALL	Behavioral: Health Advocate	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

HEalth Advocate for Liver Transplant - Pilot

Anticipated Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Changes in caregiver experience [Baseline and 90 days]
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.

Secondary Outcome Measures

Change in medication adherence using MLVI [Baseline, 90 days, and 180 days]
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.
The quality of health advocate interactions with the participants, healthcare team, and community-based resources. [90 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 caregiver and healthcare provider satisfaction with the Health Advocate intervention. [90 days]
The investigators will conduct in-depth interviews with the caregiver participant and clinical team members to assess overall satisfaction with the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94158

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sharad Wadhwani, MD, MPH, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05700799

Other Study ID Numbers:

22-36504
K23DK132454

First Posted:

Jan 26, 2023

Last Update Posted:

Jan 26, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of California, San Francisco

Health Advocate

Patient Navigator

Study Results

No Results Posted as of Jan 26, 2023