Recruiting

TBI CDS

Sponsor:

University of Minnesota

Code:

NCT05628207

Conditions

Traumatic Brain Injury

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational

Observational-control

Study Details

Brief summary:

This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.

Conditions

Traumatic Brain Injury

Venous Thromboembolism

Study ID

NCT05628207

Start date

May 16, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age 18 and older
  • admitted with a TBI

Exclusion Criteria:

  • 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.

Study Design

Enrollment

15000 participants

Anticipated

Interventions and Outcome Measures

Arms

4 hospitals using CDS TBI

healthcare system leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention.

3 hospitals not using CDS TBI (control)

healthcare system not leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention.

Interventions

Observational

There is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.

Observational-control

There is no intervention, the hospitals will not use the CDS system.

Primary outcome measure

  • primary effectiveness outcome [ Time Frame: 2 years and a half ]
  • Evaluate implementation strategy guided by the EPIS Implementation [ Time Frame: 2 years and a half ]

Central Contacts and Locations

Central contacts

Christopher Tignanelli, MD,MS

612 625 7911ctignane@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-12.