Social & Contextual Impact on Children Undergoing Liver Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
研究概览
简要总结
The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.
Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caregivers/parents of children with the following criteria will be approached for inclusion in this study:
- •Children <18 years of age at the time of transplant
- •Undergoing liver transplantation
- •Guardian's consent, child assent (in accordance with each institution's IRB policies)
- •Consents to enrollment in SPLIT
排除标准
- •Caregivers/parents of children undergoing liver transplantation will be excluded it:
- •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
- •Declined participation in SPLIT
- •Inclusion Criteria for Interview Portion of the Study:
- •Participants who have completed the questionnaire OR
- •Medical team member involved in the care of children undergoing liver transplant (e.g., physician, nurse, social worker)
结局指标
主要结局
Number of days hospitalized within 90 days after transplant, including the initial transplant hospitalization
时间窗: 90 Days
Ideal Outcome-3 (IO-3)
时间窗: 3 Years
The ideal outcome measure is a composite measure of morbidity after transplant defined as alive, ALT and GGT \<50, normal GFR, no non-liver transplants, no cytopenias, and no PTLD.
Episodes of acute cellular rejection
时间窗: 1 Year
次要结局
- Episode of re-transplantation(3 Years)
- Readmission within 90 days after transplant(90 Days)
- Episode of biopsy-proven acute cellular rejection within 90 days after transplant(90 Days)