An interventional study of Electronic Clinical Decision Support Application in Perioperative Medication Errors and Perioperative Adverse Medication Events, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Other
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).
Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia.
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.
Total time to complete 7 simulations tasks.
Total time (in seconds) to complete 7 simulations tasks.
Time frame: Measured from task start time to task end time, a cumulative average of 15 minutes
Total number of mouse clicks in 7 simulations tasks.
Total count of mouse clicks during all 7 simulations tasks.
Time frame: 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.
Time frame: Measured from task start time to task end time, a cumulative average of 15 minutes
System Usability Scale (SUS) score.
SUS is designed and validated only for first-time system users, so it will be completed by the CDS group only. SUS scores range from 0 to 100 (higher score indicates higher usability). The scores are not percentiles, but are interpreted using benchmark comparisons to industry standards.
Time frame: Measured at the conclusion of study participation, an average of 15 minutes after the participant's start time
Number of usability issues.
Usability issues are defined as aspects of the system that prevent the user from accomplishing their goals with effectiveness, efficiency and satisfaction. Usability issues will be identified for the CDS group only. Usability issues will be identified by a usability expert.
Time frame: Identified continuously over the duration of study participation, a cumulative average of 15 mins
Single Ease Question score for each simulation task.
"Overall, how difficult or easy did you find this task?" Answers will be recorded on a 7-point Likert scale (1= "very difficult"; 7= "very easy").
Time frame: Measured at the end of each of the 7 tasks (each task requires an average of 3 minutes to complete)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital