NCT04328090

Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,473 (actual)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care.

Detailed description

The aim of the EPIC trial is to assess if a multicomponent computer-based system incorporated into the workflow can reduce days of therapy (DOT) per admission after cardiovascular surgeries in the intervention surgical teams compared with controlled surgical teams, over a one-year period. This trial is an open-label, two-arm, cluster-randomized, controlled trial with cardiovascular surgical teams as the unit of randomization. Eligible teams with written consent are randomized to the intervention or control arm by random number generator. Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm. Teams in the control arm will continue with usual clinical care. The intervention includes re-evaluation alerts and decision support for the duration of antimicrobial treatment, re-evaluation alerts and decision support for the choice of antimicrobial, and quality control audit and feedback. Nine teams per arm with an average size of 1125 admissions will be recruited. Primary outcome will be the overall systemic antibiotic use measured in DOT of systemic antibiotic use per admission. Secondary outcomes include a series of indices to evaluate antimicrobial use, microbial resistance, perioperative infection outcomes, patient safety, resource consumption and user compliance/satisfaction.

Conditions

• Antimicrobial Stewardship
• Cardiovascular Surgeries
• Computerized Decision Support System
• Coronary Artery Disease
• Valve Heart Disease

Interventions

Type	Name	Description
OTHER	Computer based Antimicrobial stewardship (AMS) intervention system	1. Re-evaluation alerts and decision support for the duration of antimicrobial treatment. 2. Re-evaluation alerts and decision support for the choice of antimicrobial. 3. Quality control audit and feedback.

Timeline

• Start date: 2020-11-27
• Primary completion: 2021-05-30
• Completion: 2021-06-30
• First posted: 2020-03-31
• Last updated: 2022-03-09

Locations

1 site across 1 country: China