Evaluation of the SCALED (SCaling AcceptabLE cDs)
1 other identifier
observational
15,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedStudy Start
First participant enrolled
May 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
April 24, 2026
April 1, 2026
3.2 years
November 16, 2022
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
primary effectiveness outcome
VTE event rate
2 years and a half
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
Study Arms (2)
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.
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.
Interventions
There is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.
There is no intervention, the hospitals will not use the CDS system.
Eligibility Criteria
All patients age 18 and older admitted with a TBI will be eligible for inclusion.
You may qualify if:
- age 18 and older
- admitted with a TBI
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (1)
Tignanelli CJ, Shah S, Vock D, Siegel L, Serrano C, Haut E, Switzer S, Martin CL, Rizvi R, Peta V, Jenkins PC, Lemke N, Thyvalikakath T, Osheroff JA, Torres D, Vawdrey D, Callcut RA, Butler M, Melton GB. A pragmatic, stepped-wedge, hybrid type II trial of interoperable clinical decision support to improve venous thromboembolism prophylaxis for patients with traumatic brain injury. Implement Sci. 2024 Aug 5;19(1):57. doi: 10.1186/s13012-024-01386-4.
PMID: 39103955DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2022
First Posted
November 28, 2022
Study Start
May 16, 2023
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
April 24, 2026
Record last verified: 2026-04