Perioperative Adverse Medication Events, Perioperative Medication Errors
Conditions
Keywords
Usability, Clinical Decision Support, Anesthesiology, Medication Safety
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).
Interventions
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Anesthesia Clinicians including attending anesthesiologists, Certified Registered Nurse Anesthetists (CRNAs), and house staff (residents and fellows)
Exclusion criteria
* Study Staff * Medical Students
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total time to complete 7 simulations tasks. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 count of mouse clicks during all 7 simulations tasks. |
| 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 | Total distance traveled on the screen in pixels during all 7 simulation tasks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) score. | 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. |
| Number of usability issues. | 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. |
| 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) | 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). |
Countries
United States
Outcome results
None listed