Evaluation of the SCALED (SCaling AcceptabLE cDs)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 and older
admitted with a TBI
Disqualifiers
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.
Trial population
All patients age 18 and older admitted with a TBI will be eligible for inclusion.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionThere is no intervention, the hospitals will adopt a CDS system which prompts users to follow best practice guidelines.
Observational-control
Other interventionThere is no intervention, the hospitals will not use the CDS system.
Treatment groups
15,000 Participants
are divided into 2 treatment groupsGroup A: 4 hospitals using CDS TBI1 intervention
Group B: 3 hospitals not using CDS TBI (control)1 intervention
Trial outcomes
Primary outcomes
1
primary effectiveness outcome
VTE event rate
Time frame
2 years and a half2
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
Time frame
2 years and a halfSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Minnesota
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator
Source ClinicalTrials.gov