Evaluation of the SCALED (SCaling AcceptabLE cDs)

Recruiting

• Conditions: Traumatic Brain Injury; Venous Thromboembolism
• Interventions: Other: Observational-control; Other: Observational

• Registration Number: NCT05628207
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-16
• Study First Posted: 2022-11-28
• Study Start: 2023-05-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-11-16
• Study Completion: 2025-11-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3 hospitals not using CDS TBI (control)	Observational-control	healthcare system not leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention.
4 hospitals using CDS TBI	Observational	healthcare system leveraging the rigorous approach, SCALED (SCaling AcceptabLE cDs), to guide CDS scaling across the system in VTE prevention.

Primary Outcome Measures

Name	Time	Method
primary effectiveness outcome	2 years and a half	VTE event rate
Evaluate implementation strategy guided by the EPIS Implementation	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

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States