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

NCT04342013 | Not Yet Recruiting

• 1 other identifier: K08HS024764
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Perioperative Medication Errors; Perioperative Adverse Medication Events

Keywords

medication safety; perioperative; anesthesiology; clinical decision support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of medication errors the perioperative setting

  6 months

• Incidence of adverse medication events in the perioperative setting

  6 months

• Preventability of medication errors and adverse medication events

  6 months

• Severity of harm (or potential harm) associated with both medication errors and adverse medication events in the perioperative setting

  6 months

Study Arms (2)

Perioperative Clinical Decision Support Application

EXPERIMENTAL

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

No Perioperative Clinical Decision Support Application

NO INTERVENTION

Participants will be observed performing clinical tasks and documenting medication administrations without use of the clinical decision support application in the perioperative setting.

Interventions

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.

Perioperative Clinical Decision Support Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Study staff

Sponsors & Collaborators

• Karen C. Nanji,M.D.,M.P.H.: lead

Related Publications (1)

• 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.

  PMID: 26501385 BACKGROUND

Study Officials

• Karen C Nanji, M.D., M.P.H.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(617) 724-8544; KNANJI@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia at Harvard Medical School

Model Details: Randomized, non-blinded, parallel-arm clinical trial to assess the incidence of medication errors and adverse medication events with and without the use of an electronic clinical decision support application.

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 10, 2020
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11