Evaluation of the SCALED (SCaling AcceptabLE cDs)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05628207
Status
Recruiting
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Conditions

  • Traumatic Brain Injury
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
May 16, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
15,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

primary effectiveness outcome [ Time Frame: 2 years and a half ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Nicholas Lemke

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By research site
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