IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units.
Bruno M Tomazini, Antonio Paulo Nassar, Thiago Costa Lisboa...
https://pubmed.ncbi.nlm.nih.gov/36888821Actively Recruiting
Led by Hospital Sirio-Libanes · Updated on 2025-12-03
9000
Participants Needed
9
Research Sites
13 weeks
Total Duration
H
Hospital Sirio-Libanes
Lead Sponsor
H
Hospital do Coracao
Collaborating Sponsor
This research aims to evaluate whether an educational quality improvement intervention focused on antimicrobial stewardship can reduce antimicrobial use in adult patients admitted to intensive care units (ICUs) in Brazil. The study compares current ICU practices with those after implementing the intervention, which is based on up-to-date guidelines and aims to promote rational antimicrobial use without increasing ICU mortality or length of stay. The trial uses a stepped-wedge cluster randomized design across 10 ICUs participating in the IMPACTO-MR registry platform. The intervention includes educational sessions, cognitive aids for ICU physicians and healthcare professionals to improve decisions on antimicrobial initiation and duration, and monthly audits with feedback to the ICU teams. Each ICU starts with a control phase of usual care, then transitions to the intervention phase approximately monthly starting July 2025. The study also includes a baseline data collection period before the intervention and a phase-out period to assess lasting effects after stopping feedback. Participants are all adult patients admitted to the participating ICUs during the study. Researchers will collect monthly one-day point-prevalence surveys on antimicrobial use and monitor ICU mortality rates and length of stay over 14 months to evaluate outcomes. The study will assess the impact of the educational intervention on antimicrobial use while ensuring patient safety, with no individual informed consent required due to cluster-level data collection and minimal risk.
CONDITIONS
Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Initial site visit for educational sessions and assessment of implementation barriers
Duration - 1 month
Participants in intensive care units are observed during the control phase with routine standard-of-care practices before the quality improvement intervention begins.
Monthly point-prevalence surveys on one day each month
Duration - Up to 10 months
Participants receive a quality improvement intervention including educational sessions, cognitive aids for antimicrobial decision-making, and monthly audits with feedback to improve antimicrobial use.
Monthly one-day audits with immediate feedback sessions
Duration - 3 months
Participants are observed after the intervention phase to evaluate whether benefits in antimicrobial use are sustained without ongoing feedback.
Monthly point-prevalence surveys on one day each month
Total: 9 locations
1
Hospital Maternidade São José
Colatina, Espírito Santo, Brazil
Actively Recruiting
2
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Actively Recruiting
3
Hospital Municipal de Maringá
Maringá, Paraná, Brazil
Actively Recruiting
4
Hospital Pelópidas Silveira
Recife, Pernambuco, Brazil
Actively Recruiting
5
Hospital Naval Marcílio Dias
Rio de Janeiro, Rio de Janeiro, Brazil
Actively Recruiting
6
Hospital Onofre Lopes
Natal, Rio Grande do Norte, Brazil
Actively Recruiting
7
Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
8
Hospital Santa Cruz
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Actively Recruiting
9
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo, Brazil
Actively Recruiting
C
Camila Dietrich
B
Bruno M Tomazini
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Bruno M Tomazini, Antonio Paulo Nassar, Thiago Costa Lisboa...
https://pubmed.ncbi.nlm.nih.gov/36888821