Evaluations of CDS Systems

NCT06330740 | Not Yet Recruiting

• 1 other identifier: AAAU3416
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Safety Issues

Keywords

medication safety; patient safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Other: Clinical Decision Support

Control Arm

NO INTERVENTION

Interventions

Clinical Decision Support OTHER

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All providers placing inpatient orders on adult patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York Presbyterian Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine at CUIMC

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: March 26, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share