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Evaluation of the SCALED (SCaling AcceptabLE cDs)

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05628207
Enrollment
15000
Registered
2022-11-28
Start date
2023-05-16
Completion date
2026-09-30
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Venous Thromboembolism

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.

Interventions

OTHERObservational

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

OTHERObservational-control

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

Sponsors

University of Minnesota
Lead SponsorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
primary effectiveness outcome2 years and a halfVTE event rate
Evaluate implementation strategy guided by the EPIS Implementation2 years and a halfthe number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site

Countries

United States

Contacts

CONTACTChristopher Tignanelli, MD,MS
ctignane@umn.edu612 625 7911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026