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临床试验/NCT04216381
NCT04216381已完成不适用

Multi-Institutional Validation of Trauma Specific Frailty Index

Methodist Health System1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2019年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
Mortality

研究概览

简要总结

Increasing age is a known predictor of morbidity and mortality after a traumatic injury with worst outcomes seen in patients with age greater than 65 years. Geriatric trauma patients are a unique cohort of patients who are highly prone to develop decompensated state following the stress of traumatic event leading to adverse outcomes. In a prospective study the primary site demonstrated the presence of frailty syndrome as a better predictor of in-hospital complications and adverse discharge disposition among geriatric trauma patients than age. Presently, Methodist Dallas Medical Center aims to participate in the large scale prospective multi-institutional validation of TSFI to assess the sensitivity and specificity of Trauma Specific Frailty Index in predicting adverse outcomes through a diverse account utilizing multiple facilities.

详细描述

In the U.S, the geriatric population is the fastest growing age group. By the end of next decade, it will comprise about 20% of the total population. Frailty is a major health burden in older people. It is defined as a condition of reduced resistance to stressors, due to a decline in physiological reserves. Multiple studies have shown that frailty is associated with adverse health outcomes, such as mortality, in-hospital complications, readmissions, and adverse discharge disposition. The concept of frailty and frailty index has been implemented widely across surgical specialties to predict post-operative outcomes and mortality in aging patients.

Increasing age is a known predictor of morbidity and mortality after a traumatic injury with worst outcomes seen in patients with age greater than 65 years. Geriatric trauma patients are a unique cohort of patients who are highly prone to develop decompensated state following the stress of traumatic event leading to adverse outcomes. In a prospective study the primary site demonstrated the presence of frailty syndrome as a better predictor of in-hospital complications and adverse discharge disposition among geriatric trauma patients than age. Most of the frailty scales that exist are extensive and time consuming and their implementation in geriatric trauma patient is not feasible. To facilitate the clinical implementation of frailty in trauma Belal et al. developed the Trauma Specific Frailty Index (TSFI), which consists of 15 variables that can reliably predict the presence of frailty and pre-frailty syndrome in geriatric trauma patients. This index was based on the Rockwood CSHA frailty, which is based on deficit accumulation. In the prospective validation study of our TSFI, the 15-variable TSFI was an independent predictor adverse discharge disposition (i.e. mortality or discharge to skilled nursing facility) in geriatric trauma patients as well as adverse complications and failure to rescue. Presently, Methodist Dallas Medical Center aims to participate in the large scale prospective multi-institutional validation of TSFI.

In this prospective observational study, MDMC will participate as a site contributing to the multi-center study under the direction of Dr. Bellal at the University of Arizona. At our site, Dr. Amos will serve as site-PI.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥65 years
  • Diagnosis of physical trauma

排除标准

  • Refusal of consent.
  • Non-responsive patients who are unable to consent with no relative/proxy available to consent.

结局指标

主要结局

Mortality

时间窗: August 2019 through August 2020

death of the participant

complications

时间窗: August 2019 through August 2020

complications associated with treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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