TSFI: Trauma Specific Frailty Index

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04216381
Collaborator
(none)
500
1
35.4
14.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Trauma Specific Frailty Index Questionnaire

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Multi-Institutional Validation of Trauma Specific Frailty Index
Actual Study Start Date :
Sep 20, 2019
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Mortality [August 2019 through August 2020]

    death of the participant

  2. complications [August 2019 through August 2020]

    complications associated with treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age ≥65 years

  • Diagnosis of physical trauma

Exclusion Criteria:
  • Refusal of consent.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Joseph D Amos, MD, Methodist Dallas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT04216381
Other Study ID Numbers:
  • 048.TRA.2019.D
First Posted:
Jan 2, 2020
Last Update Posted:
Dec 13, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Methodist Health System
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 13, 2021