Evaluation of the Potential Impact of Computerized Antimicrobial Stewardship

NCT04328090 | Completed

• 1 other identifier: 2020-ZX10
• Study Type: interventional
• Target: 2,473
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (19)

• Drug usage (DDDs) per 100 PD

  From the date of admission to the date of discharge, assessed up to 60 days.

• Drug usage (DDDs) per admission

  From the date of admission to the date of discharge, assessed up to 60 days.

• Length of therapy (LOT) per 100 PD

  From the date of admission to the date of discharge, assessed up to 60 days.

• Length of therapy (LOT) per admission

  From the date of admission to the date of discharge, assessed up to 60 days.

• Days per treatment period overall and for specific indications

  From the date of admission to the date of discharge, assessed up to 60 days.

Study Arms (2)

CDSS-Antimicrobial stewardship

EXPERIMENTAL

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

Other: Computer based Antimicrobial stewardship (AMS) intervention system

Standard of care

NO INTERVENTION

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

Interventions

Computer based Antimicrobial stewardship (AMS) intervention system 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.

CDSS-Antimicrobial stewardship

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (2)

• Yuan X, Chen K, Yuan J, Chu Q, Hu S, Gao Y, Yu F, Diao X, Chen X, Li Y, Sun H, Shu C, Wang W, Pan X, Zhao W, Hu S. Evaluation of the effectiveness and safety of a multi-faceted computerized antimicrobial stewardship intervention in surgical settings: A single-centre cluster-randomized controlled trial. Int J Antimicrob Agents. 2023 May;61(5):106787. doi: 10.1016/j.ijantimicag.2023.106787. Epub 2023 Mar 17.

  PMID: 36935089 DERIVED

• 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.

  PMID: 33243799 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shengshou Hu, MD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Xin Yuan, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

• Kai Chen, PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: parallel

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 31, 2020
• Study Start: November 27, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)