HEalth Advocate for Liver Transplant - Pilot
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Health Advocate
BehavioralThe 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 90 daysSecondary outcomes
1
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.
Time frame
Baseline, 90 days, and 180 days2
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.
Time frame
90 days3
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.
Time frame
90 daysSponsors and contacts
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University of California, San Francisco
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov