NCT04216381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

March 24, 2026

Status Verified

August 1, 2023

Enrollment Period

3.9 years

First QC Date

September 12, 2019

Last Update Submit

March 20, 2026

Conditions

Physical Trauma

Keywords

geriatric

Outcome Measures

Primary Outcomes (2)

  • Mortality

    death of the participant

    August 2019 through August 2020

  • complications

    complications associated with treatment

    August 2019 through August 2020

Interventions

Trauma Specific Frailty Index QuestionnaireDIAGNOSTIC_TEST

questionnaire to assess patient's pre-injury health condition

Also known as: Trauma Specific Frailty Index

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients ≥65 years of age who admitted with a diagnosis of physical trauma between August 2019 through August 2020.

You may qualify if:

  • Age ≥65 years
  • Diagnosis of physical trauma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Joseph D Amos, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2019

First Posted

January 2, 2020

Study Start

September 20, 2019

Primary Completion

August 16, 2023

Study Completion

August 16, 2023

Last Updated

March 24, 2026

Record last verified: 2023-08

Locations

US(1)