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Recruiting

NCT Number: NCT05628207

Evaluation of the SCALED (SCaling AcceptabLE cDs)

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.

Recruiting

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Craniocerebral Trauma Embolism and Thrombosis Nervous System Diseases Thromboembolism Trauma, Nervous System Vascular Diseases Venous Thromboembolism Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Nicholas Lemke

CONTACT

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Observational

Other

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

Observational-control

Other

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

Primary outcomes

  1. primary effectiveness outcome

    Time frame: 2 years and a half

    VTE event rate

  2. Evaluate implementation strategy guided by the EPIS Implementation

    Time frame: 2 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

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Tignanelli, MD,MS

CONTACT

[email protected]

612 625 7911

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Evaluation of the SCALED (SCaling AcceptabLE cDs) Approach for the Implementation of Interoperable CDS for Venous Thromboembolism Prevention - CDS Data

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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