Usability of a Perioperative Medication-Related Clinical Decision Support Application

Study Overview
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Brief Summary
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The goal of this study is to compare the usability of a novel, medication-related clinical decision support (CDS) application to the current standard medication administration and documentation workflow. The study will occur in a simulation setting, using a manikin and test patient data - no actual patients will participate. Forty clinician participants will be randomly assigned to either the CDS group (who will complete simulation tasks using the CDS prototype) or the Control group (who will complete simulation tasks using the standard medication administration workflow).

Official Title
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Usability of a Perioperative Medication-Related Clinical Decision Support Application: A Randomized Controlled Trial

Conditions
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Perioperative Medication Errors, Perioperative Adverse Medication Events

Intervention / Treatment
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* Other: Electronic Clinical Decision Support Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows) Exclusion Criteria: Study Staff Medical Students
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDS Group<br>Clinicians complete tasks using the CDS prototype. Briefly, the clinician scans the barcode on the syringe label immediately prior to medication administration. The scan triggers the CDS to display a dosing window with pertinent patient-specific information and/or alert(s) when necessary to prevent a medication error (ME) prior to the medication being administered. Medication data are then sent from the CDS application to the patient's anesthesia record for automatic documentation in real-time, eliminating the need to manually document the medication in the Anesthesia Information Management System (AIMS). When necessary, the CDS application generates alerts to prevent medication errors. Upon receiving an alert, the anesthesia clinician may accept the alert and revise the action that generated the alert, or override the alert and continue with the planned action. | Other: Electronic Clinical Decision Support Application<br>* Robust, real-time medication-related clinical decision support application for use in the operating room. The application is fully integrated with existing clinical systems. It provides visual alerts for medication errors and adverse medication events at the point-of-care.<br>|
| No Intervention: Control Group<br>Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time to complete 7 simulations tasks. | Total time (in seconds) to complete 7 simulations tasks. | Measured from task start time to task end time, a cumulative average of 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of mouse clicks in 7 simulations tasks. | Total count of mouse clicks during all 7 simulations tasks. | Measured from task start time to task end time, a cumulative average of 15 minutes | 
| Total distance traveled on the screen in pixels for 7 simulation tasks. | Total distance traveled on the screen in pixels during all 7 simulation tasks. | Measured from task start time to task end time, a cumulative average of 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Usability, Clinical Decision Support, Anesthesiology, Medication Safety