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临床试验/NCT05597982
NCT05597982撤回不适用

How Do Structural Social Determinants of Health Affect AKT-MP and Outcomes

University of New Mexico0 个研究点开始时间: 2023年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Time to Transplant

研究概览

简要总结

Our parent award compares two patient-centered methods to facilitate KT evaluation:

kidney transplant fast track (FT), a streamlined KT evaluation process; and peer navigators (PN), a peer assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial uses a comparative effectiveness approach to assess whether FT or PN can help patients overcome barriers to transplant listing. The aims of the parent study are to: (1) compare FT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, concerns about, and ambivalence to KT; and (3) develop a framework for widespread implementation of either approach. Recent guidelines encourage using PhenX toolkit measures for kidney-disease research and clinical data reporting, but research to date has been limited by cross sectional or retrospective analyses, and incomplete or missing data on key variables, and show limited clinical application or interventions. In addition to the several PhenX individual social determinants of health (SDOH) already collected for the parent award, we propose to add PhenX structural SDOH, including concentrated poverty, food swamp, race/ethnic segregation, and social vulnerability, to our baseline data collection for all 398 patient participants under the proposed administrative supplement. Also, we will add a third assessment to determine how and whether the intervention affected post-transplant outcomes. We will follow patients via their medical records through receipt of KT to determine time to receive transplant (from time evaluation started), and type of transplant received (living or deceased donor KT). At ~6 months post-KT, participants will complete a third interview to assess KT patient reported outcomes, including health-related quality of life (QOL) and satisfaction with service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Undergoing kidney transplant evaluation at the University of New Mexico
  • Greater than or equal to 18 years of age
  • Mentally competent

排除标准

  • Inclusion across the lifespan - children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of
  • Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients.
  • Waitlisted or undergoing evaluation at another transplant center
  • Prior kidney transplant
  • Incarcerated patients
  • Pregnant women
  • Active systemic infection
  • Non-skin malignancy or melanoma in the past 2 years
  • Known cognitive impairment

结局指标

主要结局

Time to Transplant

时间窗: Through study completion, an average of 2-3 years

Time from evaluation initiation to receipt of transplant

次要结局

  • Type of transplant received(Through study completion, an average of 2-3 years)

研究者

申办方类型
Other
责任方
Sponsor

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