Usability of a Perioperative Medication-Related Clinical Decision Support Application

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

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).

Study Overview

• Status: Completed
• Conditions: Perioperative Medication Errors; Perioperative Adverse Medication Events
• Intervention / Treatment: Other: Electronic Clinical Decision Support Application

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows)

Exclusion Criteria:

• Study Staff
• Medical Students

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CDS Group; 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; 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.
No Intervention: Control Group; Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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").	Measured at the end of each of the 7 tasks (each task requires an average of 3 minutes to complete)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Karen C Nanji, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): February 10, 2021
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Usability; Anesthesiology; Medication Safety
• Other Study ID Numbers: 2020P000210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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