An interventional study of Educational Quality Improvement Intervention in Infection, Antimicrobial Stewardship and Critically Ill Intensive Care Unit Patients, sponsored by Hospital Sirio-Libanes. Recruiting at 9 sites in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Health services research
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:
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.
The SAFE-REDUCE trial is a hybrid effectiveness-implementation type 1 trial, where the investigators intend to implement a quality improvement (QI) intervention aiming to improve antimicrobial utilization in a sample of intensive care units. Their hypothesis is that this QI intervention will reduce antimicrobial consumption in the studied intensive care units. For this implementation, due to logistical constraints, the investigators can only train one intensive care unit at a time and therefore they designed a stepped-wedge cluster randomized trial to evaluate the impact of this QI intervention.
The trial will be conducted in 10 intensive care units currently participating in the IMPACTO-MR platform, a registry focused on evaluating the impact of intensive care unit acquired infections and multidrug resistant infections. IMPACTO-MR routinely collects data from the participating ICUs, including standard ICU quality improvement data. Additionally, the platform collects data on antimicrobial utilization, reported ICU-acquired infections and microbiological culture results. In the SAFE-REDUCE trial, the investigators will take advantage of this ongoing registry to test if the educational QI intervention can modulate antimicrobial utilization while maintaining the trends of ICU mortality and length-of-stay.
Each participant ICU will go through a control phase, in which they will follow their current practice, and they will be transitioned to an intervention phase, in which the quality improvement intervention will be delivered to the intensive care unit.
The QI intervention will provide cognitive aids to ICU physicians aiming at improving their decision-making for antimicrobial initiation, antimicrobial time-outs (i.e, routine revisions of the actual need for antimicrobials) and, when an infection is highly likely, deciding appropriate, shorter durations of antimicrobials. The investigators will provide intensive care units with educational sessions, a written guide for antimicrobial initiation and duration decision-making, while also accounting for key diagnostic stewardship considerations. Following an initial site visit, the investigators will collect monthly point-prevalence surveys in the ICUs regarding antimicrobial utilization in one day of the month, for the duration of the trial. During these point-prevalence surveys, feedback will be provided to the ICU provider to be delivered to the ICU team. Additionally, during the first site visit, ICUs will be encouraged to evaluate barriers and facilitators to implement the educational intervention in their units, and they will be allowed to adapt further local training based on this assessment.
All participating ICUs of the SAFE-REDUCE stepped-wedge cluster randomized trial will be transitioned to the quality improvement intervention. The investigators included a baseline period (one month before implementation, expected on June, 2025, where only routinely collected data from the IMPACTO-MR platform will be linked to SAFE-REDUCE) in all ICUs and a phase-out phase (for three months, expected to occur on May-Jul, 2026) to evaluate whether any intervention benefits sustain after the investigators stop the point-prevalence surveys and feedback.
The investigators calculated sample size based on Hemming et al. suggested method. Considering that the study ICUs screened for participating in the SAFE-REDUCE trial would have between 10 and 30 ICU beds, most of them with 20 ICU beds, assuming a conservative occupation rate of 85%, the investigators estimated that 600 patient-days per period would be included, with each participating ICU transitioning to the intervention period in 10 steps. The investigators estimate the intervention will be able to reduce up to 20% the antimicrobial consumption in the ICU and they anticipate a variable baseline rate of antimicrobial utilization, considering an intracluster correlation coefficient (ICC) of 0.1. The investigators tested different ICCs, baseline daily defined doses and reductions in their level and the sample size yielded > 90% power in all simulations.
Given the analysis at the cluster level, informed consent was waived from the institutional review board at the coordinating center and at each participating hospital institutional review boards. They agreed with a minimal risk study (i.e., participation in this study will not incur higher risk than usual random variability observed in clinical practice) and the impossibility of obtaining informed consent to withdraw data utilization, as the primary outcome data is collected at the level of the unit, not at the level of the participants.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 9,000 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Intensive care units inclusion Criteria:
Intensive care units exclusion Criteria:
- Absence of local IRB approval
Participants inclusion Criteria:
Participants exclusion Criteria:
The control group will be before the quality improvement intervention. Each ICU will be their own control and also the control group for ICUs that have already transitioned to the quality improvement arm. During this period, before transitioning to the educational QI intervention, ICUs will continue their routine standard-of-care, including any ongoing continuous quality improvement that takes part of the usual ICU management activities. Local ICUs have been disencouraged, though, to start any quality improvement initiatives aiming to improve antimicrobial consumption before their transition to the intervention phase.
Participant ICUs who have transitioned to the quality improvement intervention will be part of this arm after their first visit. The intervention will consist of cognitive aids regarding antimicrobial initiation and duration for ICU physicians and healthcare professionals involved with antimicrobial decision-making. There will also be a monthly cross-sectional evaluation of the fidelity of the intervention, with immediate feedback at each assessment to the participating ICU.
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.
Antimicrobial utilization at the ICU level
Antimicrobial utilization will be measured as daily defined doses (DDD) of antimicrobials at the ICU level per 100 patient-days
Time frame: 14 months
ICU mortality rate
ICU mortality rate adjusted for illness severity at baseline (measured with the illness severity score SAPS 3)
Time frame: 14 months
ICU length-of-stay
ICU length-of-stay, adjusted for baseline illness severity (SAPS 3)
Time frame: 14 months
Antimicrobial consumption, stratified by AWaRe WHO classification
Antimicrobial consumption measured as daily defined doses (DDDs) of antimicrobials, stratified by AWaRe WHO classification
Time frame: 14 months
Microbiological cultures collection rate
Microbiological cultures collection rate per patient-day. Results will be presented as a whole and stratified by sampling site (e.g., urinary, pulmonary, blood samples)
Time frame: 14 months
Microbiological cultures positivity rate
Microbiological cultures positivity rate per patient-day. Results will be presented as a whole and stratified by sampling site (e.g., urinary, pulmonary, blood samples)
Time frame: 14 months
Rate of skin-contaminant positive blood cultures
Skin-contaminant positive blood cultures rate per patient-day.
Time frame: 14 months
Resistance profile of positive microbiological isolates
Proportion of resistant microbiological isolates to important resistance phenotypes (for gram-negative: ceftriaxone resistance; carbapenem resistance; for gram-positive: oxacylin resistance and vancomycin resistance). Results will be presented as a whole and stratified by sampling site (e.g., urinary, pulmonary, blood samples) and type of bacteria (gram-positive or gram-negative; enterobacteria, Pseudomonas sp., Acinetobacter sp., others).
Time frame: 14 months
Ventilator-associated pneumonia (VAP) incidence rate
Ventilator-associated pneumonia (VAP) incidence rate, as reported by Brazilian regulatory agency criteria by local hospital infection control services.
Time frame: 14 months
Central-line associated bloodstream infection (CLABSI) incidence rate
Central-line associated bloodstream infection (CLABSI) incidence rate, as reported by Brazilian regulatory agency criteria by local hospital infection control services.
Time frame: 14 months
Catheter-associated urinary tract infection (CAUTI) incidence rate
Catheter-associated urinary tract infection (CAUTI) incidence rate, as reported by Brazilian regulatory agency criteria by local hospital infection control services.
Time frame: 14 months
Plan to share: Yes — Individual patient data (IPD) might be shared upon request and approval by the study steering committee after the study completion.
Started Jun 2025 (actual). Primary completion is estimated for Apr 2026, 10 months after the start.
Of 274 non-industry interventional studies with no phase under Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 51. This study's planned 10 months is below that.
Counting every sponsor, half of 305 studies reached it within 24 months; a quarter within 10 and three quarters within 50.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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