Usability of a Perioperative Medication-Related Clinical Decision Support Application

Perioperative Adverse Medication Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988737
• Other study ID #: 2020P000210
• Status: Completed
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: February 10, 2021

Study information

• Verified date: July 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Study Staff

• Medical Students

Related Conditions & MeSH terms

• Perioperative Adverse Medication Events
• Perioperative Medication Errors

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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)
Primary	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	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
Secondary	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