Usability of a Perioperative Medication-Related Clinical Decision Support Application

NCT04988737 | Completed

• 1 other identifier: 2020P000210
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Perioperative Medication Errors; Perioperative Adverse Medication Events

Keywords

Usability; Clinical Decision Support; Anesthesiology; Medication Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Total number of mouse clicks in 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.

  Measured from task start time to task end time, a cumulative average of 15 minutes

Other Outcomes (3)

• System Usability Scale (SUS) score.

  Measured at the conclusion of study participation, an average of 15 minutes after the participant's start time

• Number of usability issues.

  Identified continuously over the duration of study participation, a cumulative average of 15 mins

• Single Ease Question score for each simulation task.

  Measured at the end of each of the 7 tasks (each task requires an average of 3 minutes to complete)

Study Arms (2)

CDS Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Clinicians complete tasks using the conventional medication administration and documentation workflow in anesthesia.

Interventions

Electronic Clinical Decision Support Application OTHER

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.

CDS Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Study Staff
• Medical Students

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Karen C Nanji, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 3, 2021
• Study Start: January 27, 2021
• Primary Completion: February 10, 2021
• Study Completion: February 10, 2021
• Last Updated: November 25, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)