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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Venous Thromboembolism
• Intervention / Treatment: Other: Observational; Other: Observational-control

• Study Type: Observational
• Enrollment (Estimated): 15000

Contacts and Locations

• Study Contact: Name: Christopher Tignanelli, MD,MS; Phone Number: 612 625 7911; Email: ctignane@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Nicholas Lemke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients age 18 and older admitted with a TBI will be eligible for inclusion.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Observational; There is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.
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.	Other: Observational-control; There is no intervention, the hospitals will not use the CDS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Embolism and Thrombosis; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Thromboembolism; Brain Injuries, Traumatic; Venous Thromboembolism; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: HRP-595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No