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Completed

NCT Number: NCT04988737

Usability of a Perioperative Medication-Related Clinical Decision Support Application

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).

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Key information

Conditions

Perioperative Medication Errors Perioperative Adverse Medication Events

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Study Staff
  • Medical Students

Treatment and study plan

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.

Primary outcomes

  1. Total time to complete 7 simulations tasks.

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

    Total time (in seconds) to complete 7 simulations tasks.

Secondary outcomes

  1. Total number of mouse clicks in 7 simulations tasks.

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

    Total count of mouse clicks during all 7 simulations tasks.

  2. Total distance traveled on the screen in pixels for 7 simulation 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 during all 7 simulation tasks.

Other outcomes

  1. System Usability Scale (SUS) score.

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

    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.

  2. Number of usability issues.

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

    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.

  3. Single Ease Question score for each simulation task.

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

    "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").

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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