Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

Coronary Artery Disease Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04328090
• Other study ID #: 2020-ZX10
• Status: Completed
• Phase: N/A
• Start date: November 27, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2473
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Computer based Antimicrobial stewardship (AMS) intervention system
Re-evaluation alerts and decision support for the duration of antimicrobial treatment. Re-evaluation alerts and decision support for the choice of antimicrobial. Quality control audit and feedback.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of antimicrobial therapy (DOT) per admission	DOT represents a specific antibiotic administered to an individual patient on a calendar day independent of dose and route.	From the date of admission to the date of discharge, assessed up to 3 months.
Primary	DOT per 1000 patient-days (PD)	DOT per 1000 patient-days	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Drug usage (DDDs) per 100 PD	Items issued × Amount of drug per item per 100 PD	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Drug usage (DDDs) per admission	Items issued × Amount of drug per item per admission	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Length of therapy (LOT) per 100 PD	Number of days during which antimicrobial is used per 100 PD	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Length of therapy (LOT) per admission	Number of days during which antimicrobial is used per admission	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Days per treatment period overall and for specific indications	treatment period: antibiotic treatment not interrupted by more than one calendar day or discharge.	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Rate of participants with clostridium difficile colitis	Colitis associated with Clostridium dif?cile infection	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Incident clinical cultures with multidrug resistant organisms (MRSA, ESBL-E, CRE, VRE, or Pseudomonas aeruginosa) per 1000 PD and admission.	MRSA=methicillin-resistant Staphylococcus aureus; ESBL-E=extended spectrum beta-lactamase producing Enterobacteriaceae; CRE=Carbapenem resistant Enterobacteriaceae; VRE=vancomycin-resistant enterococci.	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	In-hospital or 30-day surgical site infections (SSIs)	Occurs within 30 days postoperatively and involves skin or subcutaneous tissue of the incision and at least one of the following: (1) purulent drainage from the incision, (2) organisms isolated from an aseptically obtained culture of fluid or tissue from the incision, (3) at least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat, and incision is deliberately opened by surgeon and is culture-positive or not cultured (a culture-negative finding does not meet this criterion), and (4) diagnosis of SSI by the surgeon or attending physician.	30 days from accomplished of the surgery.
Secondary	Rate of in-hospital bloodstream infections	Blood stream infection after surgery (ICD 10: A41.9)	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Rate of in-hospital pneumonia	Pulmonary infection after surgery (ICD 10:J98.402)	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	In-hospital or 30-day mortality, postoperative	mortality with in 30-day after the surgery	30 days from accomplished of the surgery or within hospital.
Secondary	In-hospital or 30-day myocardial infarction (MI), postoperative and newly onset	MI (in accordance with the fourth edition of MI definition) was termed type 5 MI, procedure related MI. Briefly, the criteria are as follows: Elevation of cardiac troponin (cTn)>10 times of the 9th percentile upper reference limit with patients with normal baseline; For patients with elevated preprocedural cTn values, elevation of cTn>10 fold increase and manifest a change from the baseline value of over 20%; With as least one of the following: Development of new pathological Q waves; Imaging evidence of loss of viable myocardium that is presumed to be new and in a pattern consistent with an ischemic aetiology; Angiographic findings consistent with a procedural flow-limiting complication.	30 days from accomplished of the surgery or within hospital.
Secondary	In-hospital or 30-day stroke, postoperative and newly onset	Stroke refers to newly onset stroke after surgery (ICD 10: I60.0-I60.9; I61.0-I61.9; I62.0; I62.1; I62.9; I63.0-I63.9; I64)	30 days from accomplished of the surgery or within hospital
Secondary	In-hospital or 30-day acute kidney injury (AKI) , postoperative and newly onset	AKI refers to newly onset AKI after surgery; Acute renal dysfunction within 48 hours (ICD 10: N17); AKI stage I: creatinine=26.5µmol/L; creatinine over 1.5-1.9 times of baseline value; urine output<0.5ml/kg/hour for 6-12	30 days from accomplished of the surgery or within hospital
Secondary	Length of hospital stay (LOS)	Length of hospital stay (LOS)	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Costs of administered antimicrobials (overall and by class) per admission	Costs of administered antimicrobials (overall and by class) per admission	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	Total costs of hospitalization	Total costs of hospitalization	From the date of admission to the date of discharge, assessed up to 60 days.
Secondary	User satisfaction with the system	Using questionnaire and an interview guide for the process evaluation of the intervention system.	From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.
Secondary	User compliance with the system	Ccompliance with the multicomponent intervention protocols will be assessed. This will be done by evaluating the total number of times the intervention tools fail to change the physicians' decision on antimicrobial prescription over the intervention period.	From the date of inclusion of the first patient to the date of discharge of the last patient, assessed up to 12 months.