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

Perioperative Adverse Medication Events Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04342013
• Other study ID #: K08HS024764
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Massachusetts General Hospital
• Contact: Karen C Nanji, M.D., M.P.H.
• Phone: (617) 724-8544
• Email: KNANJI[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Study staff

Related Conditions & MeSH terms

• Perioperative Adverse Medication Events
• Perioperative Medication Errors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karen C. Nanji,M.D.,M.P.H.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of medication errors the perioperative setting	Number of errors / number of medications administered	6 months
Secondary	Incidence of adverse medication events in the perioperative setting	Number of adverse medication events / number of medications administered	6 months
Secondary	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
Secondary	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