Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients

NCT07093450 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9000

Last updated 2025-12-03

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if an educational intervention with audit and feedback on physicians and health care professionals who participate in antimicrobial treatment decisions can reduce the use of antimicrobials in adult patients admitted to a sample of Brazilian intensive care units (ICUs). The educational intervention is based on a literature review of current recommendations for a more rational use of antimicrobials and microbiological tests in daily ICU practice.

The main questions it aims to answer are:

* Does the educational intervention reduce the antimicrobial consumption in the intensive care units?
* Does this educational intervention aiming to reduce antimicrobial utilization in accordance with the latest guidelines have any safety signals regarding ICU mortality rates or ICU length-of-stay?

Researchers will compare (1) ICUs sequentially randomized to this quality improvement educational intervention aimed at improving antimicrobial utilization to (2) the same ICUs at months where the educational intervention has not been delivered yet.

Each participant ICU will transition to the quality improvement intervention approximately each month, starting at July, 2025. This quality improvement intervention is based on current recommendations for antimicrobial stewardship from regulatory agencies and medical societies, including cognitive aids for physicians to improve decision-making regarding the commencement of antimicrobials, their duration and antimicrobial time-outs. The investigators hypothesize that intensivists (ICU doctors) need to embrace antimicrobial stewardship as a core competence of their daily activities.

Conditions

  • Infection
  • Antimicrobial Stewardship
  • Critically Ill Intensive Care Unit Patients

Interventions

OTHER

Educational Quality Improvement Intervention

The intervention will be delivered at the cluster level. It will include an initiation visit, when educational sessions and an operations manual will be delivered to the ICU. These will consist of cognitive aids for antimicrobial initiation and duration decision-making, based on recent recommendations from guidelines, societies and regulatory authorities. In this visit, an assessment of barriers and facilitators for implementation of the behavioral change will be done, so that local adaptations can be done by the clinicians championing the implementation. Additionally, monthly, one-day audits will be done, which will be used to provide feedback to the ICU during the intervention phase regarding the suggested recommendations for antimicrobial decision-making.

Sponsors & Collaborators

  • Hospital do Coracao

    collaborator OTHER
  • Hospital Israelita Albert Einstein

    collaborator OTHER
  • Beneficência Portuguesa de São Paulo

    collaborator OTHER
  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Bruno A M P Besen, M.D., Ph.D. · Hospital Sírio-Libanês

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2026-04-30
Completion
2026-07-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093450 on ClinicalTrials.gov