Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04216381 |
| Other study ID # |
048.TRA.2019.D |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 20, 2019 |
| Est. completion date |
August 16, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
Methodist Health System |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
