TraumaNCT07490145
Trauma Activation Criteria
An observational study of Trauma, run by Methodist Health System at 1 site in United States.
Trial summary
To quantify the over- and under-triage rates as relative to trauma activation criteria reform. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- over- and under-triage rates
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2024to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational trial will be limited by actual MDMC trauma patient volumes. We anticipate one year of observations will be adequate to establish feedback on the efficacy of the activation criteria refinement. We estimate this will include approximately 5,000 patient records.
Who may be able to join
- Patient is included in the Methodist Dallas Medical Center trauma registry. Trauma patients who recieved care at Methodist Dallas Medical Center between November 24, 2023 and November 25, 2025.
Who cannot join
- Patient does not meet registry inclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center- Clinical Research Institute
Dallas, Texas, 75203
Colette Ngo Ndjom, 214-947-1289, ClinicalResearch@mhd.com
Kavya Mankulangara, 214-947-4604, ClinicalResearch@mhd.com
About this study
Official title: Trauma Activation Criteria Refinement
To quantify the over- and under-triage rates as relative to trauma activation criteria reform.
Read the detailed description
Accurately identifying the patients requiring additional care through trauma resources drives effective resource management and quality patient care. Determining the criteria used to activate the trauma team is an essential means of managing hospital resource utilization. These criteria are based off of injury patterns, physiological findings, and mechanism of injury to predict the level of care and resource consumption.Pre-hospital criteria, however, have been described as having poor sensitivity, especially in older patients. While over-activation of trauma teams potentially reduces available resources for other patients, data suggest there is minimal risk of harm to the patient. The standardized triage assessment tool has been shown to outperform other triage assessment tools at both the single center and national levels.
- Conditions
- Trauma
- Being tested
- over- and under-triage rates
- 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.
over- and under-triage ratesOther
To quantify the over- and under-triage rates as relative to trauma activation criteria reform.
| Study group | Role | What they receive |
|---|---|---|
| Methodist Dallas Medical Center trauma registry | Trauma patients who recieved care at Methodist Dallas Medical Center between November 24, 2023 and November 25, 2025. Receives: Other: over- and under-triage rates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the over/under-triage rates
The project will be evaluated by comparing the over- and under-triage rates of the historical criteria and the reformed criteria. As the criteria reform was live November 25, 2024, pre-implementation will be defined as November 24, 2023 - November 24, 2024 and post-implementation will be defined as November 25, 2024 - November 25, 2025.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start24 Nov 2024
- Primary completion24 Nov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Burris, MD, Principal investigator, Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490145
- Sponsor's protocol ID
- 047.TRA.2024.D
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All information will be blinded in compliance with HIPAA(Health Insurance Portability and Accountability Act) regulations. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.
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
- Trauma Activation Criteria Refinement
- ClinicalTrials.gov ID
- NCT07490145
- Acronym / sponsor ID
- 047.TRA.2024.D
- Conditions
- Trauma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 24 Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
To quantify the over- and under-triage rates as relative to trauma activation criteria reform.
Detailed description
Accurately identifying the patients requiring additional care through trauma resources drives effective resource management and quality patient care. Determining the criteria used to activate the trauma team is an essential means of managing hospital resource utilization. These criteria are based off of injury patterns, physiological findings, and mechanism of injury to predict the level of care and resource consumption.Pre-hospital criteria, however, have been described as having poor sensitivity, especially in older patients. While over-activation of trauma teams potentially reduces available resources for other patients, data suggest there is minimal risk of harm to the patient. The standardized triage assessment tool has been shown to outperform other triage assessment tools at both the single center and national levels.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methodist Dallas Medical Center trauma registry | – | Other: over- and under-triage ratesTrauma patients who recieved care at Methodist Dallas Medical Center between November 24, 2023 and November 25, 2025. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational trial will be limited by actual MDMC trauma patient volumes. We anticipate one year of observations will be adequate to establish feedback on the efficacy of the activation criteria refinement. We estimate this will include approximately 5,000 patient records.
Key inclusion criteria (1 listed)
- Patient is included in the Methodist Dallas Medical Center trauma registry. Trauma patients who recieved care at Methodist Dallas Medical Center between November 24, 2023 and November 25, 2025.
Key exclusion criteria (1 listed)
- Patient does not meet registry inclusion criteria.
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 |
|---|---|---|
| over- and under-triage ratesTo quantify the over- and under-triage rates as relative to trauma activation criteria reform. | Other | Methodist Dallas Medical Center trauma registry |
Primary outcome
Determine the over/under-triage rates
Time frame: 2 year
The project will be evaluated by comparing the over- and under-triage rates of the historical criteria and the reformed criteria. As the criteria reform was live November 25, 2024, pre-implementation will be defined as November 24, 2023 - November 24, 2024 and post-implementation will be defined as November 25, 2024 - November 25, 2025.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. All information will be blinded in compliance with HIPAA(Health Insurance Portability and Accountability Act) regulations. The investigator will make all possible efforts to ensure compliance with all policies regarding sharing of protected health information or research information. Only de-identified protected health information will be shared in relevant research mediums.
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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.
Jennifer Burris, MD principal investigator
Methodist Health System
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 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 1 inclusion and 1 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, ClinicalResearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the over/under-triage rates (time frame: 2 year). 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.