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Observational Study of a Clinical Decision Support System for Traumatic Brain Injury

This study is looking at how well a special computer system, called a Clinical Decision Support (CDS) system, helps prevent blood clots (Venous Thromboembolism or VTE) in adults who have had a traumatic brain injury (TBI). The CDS system gives doctors and nurses prompts to follow best practice guidelines. Some hospitals will use this system, while others will not, allowing researchers to compare the results. The main goal is to see if using the CDS system improves patient care over two and a half years. You may be able to join if you are 18 or older and admitted to the hospital with a TBI. The study plans to include about 15,000 people.

Study design
This is an observational study, meaning researchers will watch what happens without giving any specific treatments. It aims to include about 15,000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for two and a half years to evaluate the effectiveness of the CDS system.

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NCT05628207

Evaluation of the SCALED (SCaling AcceptabLE cDs)

Recruiting
Not specifiedAges 18+Observational
University of Minnesota
~15,000 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:ObservationalObservational-control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
primary effectiveness outcome
Measured over 2 years and a half
+1 more outcome measured

Conditions

Traumatic Brain Injury
Venous Thromboembolism

Explore related trials

Traumatic EncephalopathyVenous Thromboembolism

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Christopher Tignanelli, MD,MS
[email protected]
612 625 7911
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Eligibility criteria

Inclusion

age 18 and older
admitted with a TBI

Exclusion

Patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild TBI will be excluded from final analysis.

What this trial measures

  • primary effectiveness outcome2 years and a half

    VTE event rate

  • Evaluate implementation strategy guided by the EPIS Implementation2 years and a half

    the number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site