Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trauma Specific Frailty Index (TSFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216381
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

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 (9). 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 (10,11). 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
Physical Trauma 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 (1). Frailty is a major health burden in older people (2,3). 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 (4,5). 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 (9). 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 (10,11). 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 (12) 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multi-Institutional Validation of Trauma Specific Frailty Index
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Trauma Specific Frailty Index Questionnaire
    questionnaire to assess patient's pre-injury health condition
    Other Name: Trauma Specific Frailty Index


Primary Outcome Measures :
  1. Mortality [ Time Frame: August 2019 through August 2020 ]
  2. complications [ Time Frame: August 2019 through August 2020 ]
  3. Demographics [ Time Frame: August 2019 through August 2020 ]
    age, sex, ethnicity

  4. injury characteristics [ Time Frame: August 2019 through August 2020 ]
    (ISS, AIS, mechanism, cause of injury

  5. comorbidities [ Time Frame: August 2019 through August 2020 ]
  6. GCS [ Time Frame: August 2019 through August 2020 ]
    eye, verbal, motor, total

  7. medication history [ Time Frame: August 2019 through August 2020 ]
  8. ventilator days [ Time Frame: August 2019 through August 2020 ]
  9. hospital length of stay [ Time Frame: August 2019 through August 2020 ]
  10. ICU length of stay [ Time Frame: August 2019 through August 2020 ]
  11. 30 day readmission [ Time Frame: August 2019 through August 2020 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients ≥65 years of age who admitted with a diagnosis of physical trauma between August 2019 through August 2020.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216381


Contacts
Layout table for location contacts
Contact: Crystee Cooper, DHEd 214-947-1280 CCooper@mhd.com
Contact: Jordania L Lilly, MEd 214-947-1280 JordaniaLilly@mhd.com

Locations
Layout table for location information
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Crystee Cooper, DHEd    214-947-1280    CrysteeCooper@mhd.com   
Contact: Jordania L Lilly, MEd    (214) 947-1280    jordanialilly@mhd.com   
Sponsors and Collaborators
Methodist Health System
Investigators
Layout table for investigator information
Principal Investigator: Joseph D Amos, MD Methodist Dallas Medical Center
Layout table for additonal information
Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04216381    
Other Study ID Numbers: 048.TRA.2019.D
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Methodist Health System:
geriatric
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Wounds and Injuries
Pathologic Processes