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Clinical Trials/NCT04988737
NCT04988737CompletedNot Applicable

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

Massachusetts General Hospital1 site in 1 country40 target enrollmentStarted: January 27, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Total time to complete 7 simulations tasks.

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Electronic Clinical Decision Support Application (Other)

Control Group

No Intervention

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

Outcomes

Primary Outcomes

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

  • 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 number of mouse clicks in 7 simulations tasks.(Measured from task start time to task end time, a cumulative average of 15 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen C. Nanji,M.D.,M.P.H.

Principal Investigator

Massachusetts General Hospital

Study Sites (1)

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