Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship (EPIC)

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Coronary Artery Disease; Computerized Decision Support System; Valve Heart Disease; Antimicrobial Stewardship; Cardiovascular Surgeries

Treatments: Other: Computer based Antimicrobial stewardship (AMS) intervention system

Study type: Interventional

Funder types: Other

Identifiers

NCT04328090

2020-ZX10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,473 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over 18 years of age;
2. Receiving at least one open-chest cardiovascular surgery during the same admission.

Exclusion criteria

1. Intravenous or oral antimicrobial use within two weeks before surgery;
2. Emergent/urgent surgery;
3. Admitted for isolated stenting or heart transplantation or implantation of ventricular assist device or implantation of extracorporeal membrane oxygenation;
4. Admitted for subacute bacterial endocarditis;
5. Length of ICU stay over 48 hours.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,473 participants in 2 patient groups

CDSS-Antimicrobial stewardship

Experimental group

Description:

Computer-based, multicomponent intervention targeting on reduction of perioperative antimicrobial use will be delivered to teams in the intervention arm.

Treatment:

Other: Computer based Antimicrobial stewardship (AMS) intervention system

Standard of care

No Intervention group

Description:

Teams in the control arm will continue with usual standard clinical care.