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Studies

Interventional Recruiting

NCT07093450 on ClinicalTrials.gov

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

Official title: Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva

  • Sponsor: Hospital Sírio-Libanês
  • Collaborators: Hospital do Coracao, Hospital Israelita Albert Einstein, Beneficência Portuguesa de São Paulo
  • Enrollment: 9000 (Estimated)
  • Study start: 2025-06-01 (Actual)
  • Primary completion: 2026-04-01 (Estimated)
  • Study completion: 2026-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Sequential
  • InterventionModelDescription: The study is a stepped-wedge cluster randomized trial, in which each of the 10 intensive care units will be randomized to receive a quality improvement intervention at each month. They will know about their allocation with 1-2 months preceding the commencement of the quality improvement intervention. There will be no transition period for the primary analysis. As the study is at the cluster level, no blinding will be possible.
  • Masking: None
  • PrimaryPurpose: Health Services Research

Brief 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

Intervention / Treatment

  • Other: Educational Quality Improvement Intervention

Primary Outcome Measures

  • Antimicrobial utilization at the ICU level (14 months)
    Antimicrobial utilization will be measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days

Countries

Brazil

Locations and Investigators

  • Hospital Maternidade São José, Colatina, Brazil (Recruiting)
    • Rodrigo C Figueiredo
  • Santa Casa de Misericórdia de Passos, Passos, Brazil (Recruiting)
    • Priscila F N Gonçalves
  • Hospital Municipal de Maringá, Maringá, Brazil (Recruiting)
    • Ana Cristina M Gurgel
  • Hospital Pelópidas Silveira, Recife, Brazil (Recruiting)
    • Lívia A Medeiros
  • Hospital Naval Marcílio Dias, Rio de Janeiro, Brazil (Recruiting)
    • Vitor A Borges
  • Hospital Onofre Lopes, Natal, Brazil (Recruiting)
    • Gisele R Borba
  • Hospital de Pronto Socorro, Porto Alegre, Brazil (Recruiting)
    • Cristiano A Franke
  • Hospital Santa Cruz, Santa Cruz do Sul, Brazil (Recruiting)
    • Maitê S Magdalena
  • Santa Casa de Misericórdia de Barretos, Barretos, Brazil (Recruiting)
    • Isaac F D Favaro

Study Officials