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临床试验/NCT02826460
NCT02826460已完成不适用

Psychosocial Predictors of Posttransplant Adherence and Outcomes

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Incidence of Rejection

研究概览

简要总结

A retrospective chart review in which the information in the standard psychosocial evaluations done pre-transplant for liver transplant recipients will be coded, recorded, and correlated with posttransplant outcomes of the same recipients. Evaluated outcomes include rejection episodes and adherence to tacrolimus, calculated through the MLVI (Medication Level Variability Index). The researchers will evaluate the degree to which both single elements in the evaluation as well as a cumulative score derived by a structured review of the chart using the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) model can predict posttransplant outcomes.

详细描述

The research team will perform a chart review and extract data without identifiers from paper charts and electronic charts and data tracking system. This data will be obtained from OTTR /EPIC as well as paper charts if needed. Those charts will be accessed to obtain demographic data (age, gender, income, employment status, marital/relationship status, insurance payer); transplant specific data (primary diagnosis, transplant year, tacrolimus blood levels, rejection episodes (yes/ no and number of), graft loss (yes/no), re-transplantation (yes/no); related medical data (creatinine levels, dialysis dependence (yes/no), ICD diagnoses; and psychosocial variables (social worker risk assessment before transplant, presence of social and family support, conviction history (yes/no), psychiatric history (diagnoses yes/no).

Variables will be obtained from the psychosocial pretransplant evaluation write-up (which in different years was attached to OTTR or EPIC datasets, or may be present in paper form, and from electronic datasets (OTTR / EPIC).

The data extraction as well as dataset building and data entry will be performed in office spaces at ISMMS. No patient contact is anticipated for this study. The predictive model will include evaluations of single variables as well as an evaluation of the predictive ability of a pre-defined scoring system (the SIPAT) which will be applied to existing data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Received a liver transplant in the year 2012 or earlier
  • Received Tacrolimus
  • Had at least 3 Tacrolimus blood tests
  • Received their transplant at RMTI

排除标准

  • Patients who received more than 1 solid organ transplant
  • Patients who were not prescribed Tacrolimus
  • Patients who died within the first year after transplant
  • Patients with cognitive impairment

结局指标

主要结局

Incidence of Rejection

时间窗: 2 years

Number of Rejections confirmed by biopsy

次要结局

  • Medication Level Variability Index (MLVI)(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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