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

ConditionsInfection Antimicrobial Stewardship Critically Ill Intensive Care Unit Patients

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHospital Sirio-Libanes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ICU leadership acceptance to participant in the quality improvement intervention;

Hospital infection control leadership acceptance to participant in the quality improvement intervention;

ICU participation in the IMPACTO-MR platform with high quality data;

ICU potential for quality improvement based on a subjective assessment of the ICU and hospital infection leaderships

Disqualifiers

All patients admitted to the intensive care unit

Patients younger than 18 years-old will be excluded from individual-level analysis

Trial design

Design model

Sequential

Treatments tested in this trial

Educational Quality Improvement Intervention
Other 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.

Treatment groups

9,000 Participants

are divided into 2 treatment groups

Group A: ICU Standard-of-careNo intervention 0 interventions

Group B: Educational Quality Improvement InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

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Hospital Sirio-Libanes

Lead sponsor

Hospital do Coracao

Collaborator

Hospital Israelita Albert Einstein

Collaborator

Beneficência Portuguesa de São Paulo

Collaborator

Source ClinicalTrials.gov

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