Clinical trial NCT04328090: Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship
Official title: Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship on the Antimicrobial Use After Cardiovascular Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antimicrobial Stewardship
Cardiovascular Surgeries
Computerized Decision Support System
Coronary Artery Disease
Valve Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-03-31
Enrollment: 2473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Days of antimicrobial therapy (DOT) per admission
timeFrame: From the date of admission to the date of discharge, assessed up to 3 months.
measure: DOT per 1000 patient-days (PD)
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
Secondary outcomes:
measure: Drug usage (DDDs) per 100 PD
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Drug usage (DDDs) per admission
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Length of therapy (LOT) per 100 PD
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Length of therapy (LOT) per admission
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Days per treatment period overall and for specific indications
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Rate of participants with clostridium difficile colitis
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Incident clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CRE, VRE, or Pseudomonas aeruginosa) per 1000 PD and admission.
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: In-hospital or 30-day surgical site infections (SSIs)
timeFrame: 30 days from accomplished of the surgery.
measure: Rate of in-hospital bloodstream infections
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Rate of in-hospital pneumonia
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: In-hospital or 30-day mortality, postoperative
timeFrame: 30 days from accomplished of the surgery or within hospital.
measure: In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset
timeFrame: 30 days from accomplished of the surgery or within hospital.
measure: In-hospital or 30-day stroke, postoperative and newly onset
timeFrame: 30 days from accomplished of the surgery or within hospital
measure: In-hospital or 30-day acute kidney injury (AKI) , postoperative and newly onset
timeFrame: 30 days from accomplished of the surgery or within hospital
measure: Length of hospital stay (LOS)
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Costs of administered antimicrobials (overall and by class) per admission
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: Total costs of hospitalization
timeFrame: From the date of admission to the date of discharge, assessed up to 60 days.
measure: User satisfaction with the system
timeFrame: From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
measure: User compliance with the system
timeFrame: From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shengshou Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Xin Yuan, PhD
role: STUDY_CHAIR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Kai Chen, PhD
role: STUDY_DIRECTOR
References:
citation: Yuan X, Chen K, Zhao W, Hu S, Yu F, Diao X, Chen X, Hu S. Open-label, single-centre, cluster-randomised controlled trial to Evaluate the Potential Impact of Computerisedantimicrobial stewardship (EPIC) on the antimicrobial use after cardiovascular surgeries: EPIC trial study original protocol. BMJ Open. 2020 Nov 26;10(11):e039717. doi: 10.1136/bmjopen-2020-039717.