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

NCT ID: NCT04342013

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2027-01-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Perioperative Medication Errors Perioperative Adverse Medication Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Electronic Clinical Decision Support Application

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Study staff
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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

Assistant Professor of Anesthesia at Harvard Medical School

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Central Contacts

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

Role: CONTACT

(617) 724-8544

References

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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.

Reference Type BACKGROUND
PMID: 26501385 (View on PubMed)

Other Identifiers

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K08HS024764

Identifier Type: AHRQ

Identifier Source: org_study_id

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