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NCT05628207 Clinical Trial

Evaluation of the SCALED (SCaling AcceptabLE cDs)

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05628207
Other study ID # HRP-595
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 16, 2023
Est. completion date November 16, 2025

Study information
Verified date April 2024
Source University of Minnesota
Contact Christopher Tignanelli, MD,MS
Phone 612 625 7911
Email ctignane@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 15000
Est. completion date November 16, 2025
Est. primary completion date November 16, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• 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.

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
University of Minnesota Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary primary effectiveness outcome VTE event rate 2 years and a half
Primary Evaluate implementation strategy guided by the EPIS Implementation the number of patients that received treatment according to the best practice guideline and the % adherence to the guideline per site 2 years and a half
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