Physical TraumaTSFINCT04216381
Trauma Specific Frailty Index
An observational study of Physical Trauma, run by Methodist Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Physical Trauma
- What is being tested?
- Trauma Specific Frailty Index Questionnaire
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 16 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients ≥65 years of age who admitted with a diagnosis of physical trauma between August 2019 through August 2020.
Who may be able to join
- Age ≥65 years
- Diagnosis of physical trauma
Who cannot join
- Refusal of consent.
- Non-responsive patients who are unable to consent with no relative/proxy available to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Multi-Institutional Validation of Trauma Specific Frailty Index
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.
Read the 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.
- Conditions
- Physical Trauma
- Being tested
- Trauma Specific Frailty Index Questionnaire
- Keywords
- geriatric
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma Specific Frailty Index QuestionnaireDiagnostic test
Also called Trauma Specific Frailty Index
questionnaire to assess patient's pre-injury health condition
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
death of the participant
Measured: August 2019 through August 2020
complications
complications associated with treatment
Measured: August 2019 through August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start20 Sep 2019
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph D Amos, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216381
- Sponsor's protocol ID
- 048.TRA.2019.D
- Acronym
- TSFI
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2019
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Institutional Validation of Trauma Specific Frailty Index
- ClinicalTrials.gov ID
- NCT04216381
- Acronym / sponsor ID
- TSFI / 048.TRA.2019.D
- Conditions
- Physical Trauma
- Keywords
- geriatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients ≥65 years of age who admitted with a diagnosis of physical trauma between August 2019 through August 2020.
Key inclusion criteria (2 listed)
- Age ≥65 years
- Diagnosis of physical trauma
Key exclusion criteria (2 listed)
- Refusal of consent.
- Non-responsive patients who are unable to consent with no relative/proxy available to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma Specific Frailty Index QuestionnaireAlso: Trauma Specific Frailty Indexquestionnaire to assess patient's pre-injury health condition | Diagnostic test | – |
Primary outcome
Mortality
Time frame: August 2019 through August 2020
death of the participant
complications
Time frame: August 2019 through August 2020
complications associated with treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D Amos, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physical Trauma, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: August 2019 through August 2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.