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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04342013
Enrollment
300
Registered
2020-04-10
Start date
2027-01-31
Completion date
2027-12-31
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Adverse Medication Events, Perioperative Medication Errors

Keywords

medication safety, perioperative, anesthesiology, clinical decision support

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.

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

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Study staff

Design outcomes

Primary

MeasureTime frameDescription
Combined incidence of medication errors and adverse medication events in the perioperative setting6 monthsNumber of medication errors and adverse medication events / number of medications administered

Secondary

MeasureTime frameDescription
Incidence of medication errors the perioperative setting6 monthsNumber of errors / number of medications administered
Incidence of adverse medication events in the perioperative setting6 monthsNumber of adverse medication events / number of medications administered
Preventability of medication errors and adverse medication events6 monthsFour-point Likert scale for preventability: definitely preventable, probably preventable, probably not preventable, and definitely not preventability
Severity of harm (or potential harm) associated with both medication errors and adverse medication events in the perioperative setting6 monthsFour-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.

Contacts

Primary ContactKaren C Nanji, M.D., M.P.H.
KNANJI@mgh.harvard.edu(617) 724-8544

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026