Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2473 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-27

Study Completion Date

2021-06-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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CDSS-Antimicrobial stewardship

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

Group Type EXPERIMENTAL

Computer based Antimicrobial stewardship (AMS) intervention system

Intervention Type OTHER

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.

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No