RCT: The Effect of an Electronic Clinical Decision Support Application on Perioperative Medication Errors.

Impact of a Novel Electronic Clinical Decision Support Application on Perioperative Medication Errors and Adverse Medication Events: a Randomized Controlled Trial

The purpose of this study is to assess the effect of a novel clinical decision support application on the rate of perioperative medication errors and preventable adverse medication events. The investigators hypothesize that the perioperative clinical decision support application will reduce the incidence of perioperative medication errors and adverse medication events compared to the standard of care.

Study Overview

• Status: Unknown
• Conditions: Perioperative Medication Errors; Perioperative Adverse Medication Events
• Intervention / Treatment: Other: Electronic Clinical Decision Support Application

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen C Nanji, M.D., M.P.H.; Phone Number: (617) 724-8544; Email: KNANJI@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Anesthesia clinician (anesthesiologists, certified registered nurse anesthetists (CRNAs), student nurse anesthetists, fellows and residents) at Massachusetts General Hospital.

Exclusion Criteria:

• Study staff

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perioperative Clinical Decision Support Application; Participants will be observed performing clinical tasks and documenting medication administrations with use of the clinical decision support application in the perioperative setting.	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.
NO_INTERVENTION: No Perioperative Clinical Decision Support Application; Participants will be observed performing clinical tasks and documenting medication administrations without use of the clinical decision support application in the perioperative setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined incidence of medication errors and adverse medication events in the perioperative setting	Number of medication errors and adverse medication events / number of medications administered	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of medication errors the perioperative setting	Number of errors / number of medications administered	6 months
Incidence of adverse medication events in the perioperative setting	Number of adverse medication events / number of medications administered	6 months
Preventability of medication errors and adverse medication events	Four-point Likert scale for preventability: definitely preventable, probably preventable, probably not preventable, and definitely not preventability	6 months
Severity of harm (or potential harm) associated with both medication errors and adverse medication events in the perioperative setting	Four-point Likert scale for severity: Fatal Life-threatening: The event has the potential to cause symptoms that if not treated would put the patient at risk of death. Serious: The event has the potential to cause symptoms that are associated with a serious level of harm that is not high enough to be life-threatening. Significant: The event has the potential to cause symptoms that while harmful to the patient pose little or no threat to the patient's function.	6 months

Collaborators and Investigators

• Sponsor: Karen C. Nanji,M.D.,M.P.H.
• Investigators: Principal Investigator: Karen C Nanji, M.D., M.P.H., Massachusetts General Hospital

Publications and helpful links

General Publications

• Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016 Jan;124(1):25-34. doi: 10.1097/ALN.0000000000000904.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (ACTUAL): April 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: perioperative; clinical decision support; anesthesiology; medication safety
• Other Study ID Numbers: K08HS024764 (AHRQ)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No