Health Advocate for Children After Liver Transplant: A Hybrid Implementation Effectiveness RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient <18 years old at the time of liver transplant
- •Received a liver transplant within past 90 days
- •Family endorses material economic hardship on 10-questions Accountable Healthcare Communities screening tool.
- •Will receive follow-up care for at least 2 years
- •Family can read or write English or Spanish
- •A Legally Authorized Representative (LAR) can provide consent, and for children (12-17 years of age, the child is willing/able to provide assent.)
- •Family has a working phone and smartphone device capable of receiving calls or virtual visits via Zoom.
排除标准
- •Patient has severe cognitive impairment.
- •18 years of age or older at the time of consent
- •Patient unwilling or unable to consent/participate
- •Patient 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 as ICFs, HIPAA authorization form, surveys, and interviews will only be available in these 2 languages. Languages besides English and Spanish are excluded from this study.
研究组 & 干预措施
Enhanced Control
The caregiver will receive a printed sheet of resources once and a follow-up call at the 45-day timepoint with a reminder of the suggested resources.
干预措施: Enhanced Control (Behavioral)
Health Advocate Intervention
The caregiver will receive 90-days of tailored health advocate intervention
干预措施: Health advocate (Behavioral)
结局指标
主要结局
Time-to-TCMR between 90 days and 2 years post-transplant using Kaplan-Meir plots.
时间窗: 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.
次要结局
- Parent-Reported Social Service Utilization (Count of Services Received)(90-days post enrollment)
- Change in Parent-Reported Social Service Utilization From Baseline to 90 Days(Baseline and 90 days post-enrollment)
- Parent-Reported Social Needs Score at Baseline (SIREN-Informed PRO Measure)(Baseline)
- Parent-Reported Social Needs Score at 90 Days (SIREN-Informed PRO Measure)(90-days post enrollment)
- Measurement of incidence of Medication Level Variability Index >2.0 using generalized linear mixed effect models.(Through study completion, an average of one year up to 2 years.)
- Change in Parent-Reported Social Needs Score From Baseline to 90 Days (SIREN-Informed PRO Measure)(Baseline and 90-days post enrollment)
- Liver inflammation (ALT or GGT >50) and overimmunosuppression (positive EBV or CMV PCR) at years 1 and 2 using linear mixed effects models.(An average of 1 year up to 2 years.)