Evaluations of CDS Systems

Reducing Medication Ordering Errors Through Indications-Based Prescribing

Indications-based prescribing is a medication ordering system in which a clinician selects an indication, and then the electronic health record (EHR) suggests an appropriate medication regimen. This approach was shown to significantly decrease medication ordering errors in a prototype environment. However, the effect of indications-based prescribing on preventing ordering errors has not been rigorously evaluated in a real-world healthcare setting. Antibiotics are the medication class most likely to contain ordering errors, which can lead to significant patient harm. At NewYork-Presbyterian (NYP) a robust antimicrobial indication-based order set was developed to help clinicians identify the appropriate antibiotic, dose, frequency, and duration, based on type of infection and patient-specific characteristics, but it is not widely used. The investigators propose a randomized controlled trial to assess the effectiveness of this indications-based order set for reducing antimicrobial ordering errors.

Study Overview

• Status: Not yet recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Other: Clinical Decision Support

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All providers placing inpatient orders on adult patients.

Exclusion Criteria:

Providers placing orders on patients who were ordered for antibiotics >24 hours in the past 72 hours and/or patients with positive cultures during that admission, and/or placing an order from the order set.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm	Other: Clinical Decision Support; Upon ordering antibiotics the provider will be prompted to utilize an indication-based order set which guides the clinician to the appropriate empiric antibiotic choice.
No Intervention: Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The combined rate of Wrong Drug, Wrong Duration, Wrong Dose and Wrong Frequency Retract-And-Reorder (RAR) events will be combined to create an overall rate of near-miss ordering errors in the control and intervention arm.	Novel Health IT measures which utilize provider ordering patterns to capture near-miss ordering errors.	Up to 18 months

Collaborators and Investigators

• Sponsor: New York Presbyterian Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: patient safety; medication safety
• Other Study ID Numbers: AAAU3416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No