NCT Number: NCT07279350
The HEAL-Tx is a 90-day intervention, in which a Health Advocate works with eligible families to identify and apply for community-based resources, alert healthcare providers to challenges the family is encountering, and guide health system navigation (e.g., coordinating appointments). Families in the control arm will receive a printed handout that provides contact information for local community-based resources. Families in the treatment arm will receive HEAL-Tx.
Interested in participating?
Request Info0 year–18 year
All sexes
Interventional
Not applicable
University of California, San Francisco, San Francisco, California, United States
HEAL-Tx trial is a Type 1 hybrid effectiveness-implementation trial across 6 U.S. transplant centers (UCSF, Seattle Children's Hospital, Stanford University, Children's Healthcare of Atlanta, University of Pittsburgh, Children's Hospital of Colorado.) Children/families will be screened for material economic hardship as part of standard of care during their transplant hospitalization using the 10-question Accountable Healthcare Communities tool. Families who report material economic hardship will be approached for study participation, and those who consent will be randomized to either the control or treatment arm. Participants in the control arm will receive enhanced standard of care: they will receive a printed handout with a list of resources specific to their hardship and their home ZIP code. They will also receive a follow-up call at 45-days with a reminder of the suggested resources. Participants in the treatment arm will receive a customized 90-day Health Advocate intervention. Both the treatment and control arm group will complete a baseline interview and a close-out 90-day interview to assess outcomes and experiences with the intervention. The treatment arm will have one additional interview at the 45-day timepoint. Once both arms complete treatment, they will have data extracted from their medical records at the 1, and 2-year timepoint.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The health advocate is a trained individual who is not a part of the medical team. They work directly with the caregivers of patients who have received a liver transplantation to assist them with navigating the healthcare system, find resources, and relay any concerns to their medical team. They work with an assigned family for 90-days and tailor their intervention to meet the families social needs.
Other names: HA
Caregivers in the control arm will receive enhanced standard of care: they will be given a handout with a list of resources specific to their hardship and their home ZIP code. They will receive a follow-up call at 45 days with a reminder of the suggested resources.
Time frame: Through study completion, an average of 1 year up to 2 years.
After the perioperative period, it is an objective outcome closely linked with poor adherence/challenges with self-management. Investigators found strong associations between material economic hardship and TCMR episodes of TCMR increase risks of graft failure/death post-transplant and early TCMR increases risk of late TCMR and vulnerability to infections. All analyses will be intention-to-treat. Investigators will use Kaplan-Meier plots to descriptively compare survival distributions of the primary outcome (TCMR) by trial arm. We will compare time-to-TCMR between treatment arms using Cox regression. For participants recruited in years 1 & 2 of the study period, we will collect 2 years of follow-up data. For participants recruited in year 3, we will apply administrative censoring after 1 year of follow up data.
Time frame: Through study completion, an average of one year up to 2 years.
An MLVI >2.0 predicted late TCMR, even after accounting for other causes of tacrolimus fluctuations. In the first 6 months after transplant, tacrolimus levels can fluctuate based on physiological changes associated with transplant. After 6 months, fluctuations are most likely related to poor adherence. Investigators will measure the incidence of MLVI >2.0 between 6 months - 1 year, and 1year and 2 years. If a patient has an episode of TCMR within this time, investigators will only collect tacrolimus levels preceding this event. Investigators will calculate MLVI based on available levels for 6 months - 1 year, and for 1year - 2 years. Investigators will use generalized linear mixed effects models for dichotomous outcomes to analyze MLVI >2.0. Models will also include random effects for each patient, and fixed effects that include trial arm, time since randomization and site. If differences in groups are observed, interaction terms may be introduced to assess heterogeneity in trends.
Time frame: Baseline and 90-days post enrollment
Parent-reported social needs will be assessed using a SIREN-informed patient-reported outcome measure. Scores will be calculated at baseline and 90 days. Change scores will be compared between treatment arms using a t-test, and the primary analysis will use linear regression (ANCOVA) with the baseline score as a covariate to estimate the mean difference in change between groups.
Time frame: An average of 1 year up to 2 years.
Investigators will use generalized linear mixed effects models for dichotomous outcomes to analyze liver inflammation and overimmunosuppression. Models will include random effects for each patient, and fixed effects for trial arm, time since randomization (allowing investigators to assess trends), and site.
Time frame: 90-days post enrollment
Parents will report whether social services were received in the 90-day period following enrollment. Investigators will summarize utilization using counts and percentages and compare across centers using chi-square tests.
Time frame: Baseline and 90 days post-enrollment
Receipt of social services will be recorded at baseline and 90 days. The change in utilization will be compared between treatment arms using t-tests and modeled using ANCOVA with baseline utilization as a covariate.
Time frame: Baseline
Baseline social needs scores will be summarized using medians and quartiles for continuous measures.
Time frame: 90-days post enrollment
Follow-up social needs scores at 90 days will be summarized and compared across centers using Kruskal-Wallis tests.
Time frame: Baseline, Day-45 (treatment arm only), 90-day timepoints
Reach: Differences in EHR-abstracted sociodemographic characteristics and center differences (enrolled vs. declined) Adoption: Differences in adoption by clinician type Implementation: Identify factors from enrollment associated with quantitative implementation measures Maintenance: Investigators will analyze whether attrition rates differ by type
Investigators will collect interviews from both treatment arms at baseline and the 90-day timepoint. Patients in the treatment arm will have one additional qualitative interview (45-day timepoint.) The interviews will be recorded and transcribed. Codebooks will be developed for the caregiver, health advocate and clinician informant interviews using COM-B components to identify barriers and facilitators to adoption, implementation and maintenance. Investigators will iteratively refine and update the codebooks during data collection, allowing for open coding to occur to capture inductive codes. Each transcript will be coded by two coders.
Contact information is provided by the study sponsor or research team.
Andrea Huerta
CONTACT
Bethany Reyna, BA, CCRP
CONTACT
University of California, San Francisco
Other
Health Advocate for Children After Liver Transplant: A Hybrid Implementation Effectiveness RCT
Acronym: HEAL-Tx:RCT
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