The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients (HEAL-Tx:ToC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06386198
Recruitment Status : Recruiting
First Posted : April 26, 2024
Last Update Posted : April 26, 2024
Sponsor:
Collaborator:
American Society of Transplantation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Pediatric ALL Behavioral: Health Advocate Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients
Actual Study Start Date : March 3, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Patient Navigator


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in patient experience [ Time Frame: 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 :
  1. Change in medication adherence using MLVI [ Time Frame: 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.

  2. The quality of health advocate interactions with the participants, healthcare team, and community-based resources. [ Time Frame: 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.

  3. A qualitative assessment of patient and healthcare provider satisfaction with the Health Advocate intervention. [ Time Frame: 180 days ]
    The investigators will conduct in-depth interviews with the patient participant and clinical team members to assess overall satisfaction with the intervention.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has received a liver transplant >1 year ago
  2. Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.
  3. Patient has an unmet social risk (e.g., food insecurity) or MLVI >/= 2.0.
  4. Patient will be transferred to adult transplant team in <6 months.
  5. Patient can read and write English or Spanish
  6. Patient is between 18-25 years old and can provide informed consent.
  7. Patient has a working phone and smart device capable of video and/or audio virtual visits via Zoom.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06386198


Contacts
Layout table for location contacts
Contact: Sharad Wadhwani, MD, MPH 510-428-3058 sharad.wadhwani@ucsf.edu

Locations
Layout table for location information
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94158
Contact: Emily Stekol    415-502-3190    emily.stekol@ucsf.edu   
Principal Investigator: Sharad Wadhwani, MD, MPH         
United States, Georgia
Children's Healthcare of Atlanta Not yet recruiting
Atlanta, Georgia, United States, 30345
Contact: Nitika Gupta         
Principal Investigator: Nitika Gupta         
Sponsors and Collaborators
University of California, San Francisco
American Society of Transplantation
Investigators
Layout table for investigator information
Principal Investigator: Sharad Wadhwani, MD, MPH University of California, San Francisco
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT06386198    
Other Study ID Numbers: 23-40699
First Posted: April 26, 2024    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Health Advocate
Patient Navigator