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

Study Overview
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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.

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

Conditions
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Perioperative Medication Errors, Perioperative Adverse Medication Events

Intervention / Treatment
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* Other: Electronic Clinical Decision Support Application


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perioperative Clinical Decision Support Application<br>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<br>* 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.<br>|
| No Intervention: No Perioperative Clinical Decision Support Application<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medication safety, perioperative, anesthesiology, clinical decision support