Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients
NCT ID: NCT07093450
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
9000 participants
INTERVENTIONAL
2025-06-01
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Simulation Training as a Tool for Teamwork Improvement in Multidisciplinary Intensive Care Team
NCT00229411
Education Program for Cardiac Patients
NCT01341093
Proactive Ethics Intervention to Improve Intensive Care Unit (ICU) Care
NCT00996814
Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine.
NCT04278976
Evidence-Based Practice: Proposed Application of Facilitating Tools for Clinical Nurses
NCT04483713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ICU Standard-of-care
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.
No interventions assigned to this group
Educational Quality Improvement Intervention
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* All patients admitted to the intensive care unit
Exclusion Criteria
* Patients younger than 18 years-old will be excluded from individual-level analysis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital do Coracao
OTHER
Hospital Israelita Albert Einstein
OTHER
Beneficência Portuguesa de São Paulo
OTHER
Hospital Sirio-Libanes
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruno A M P Besen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hospital Sírio-Libanês
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Maternidade São José
Colatina, Espírito Santo, Brazil
Santa Casa de Misericórdia de Passos
Passos, Minas Gerais, Brazil
Hospital Municipal de Maringá
Maringá, Paraná, Brazil
Hospital Pelópidas Silveira
Recife, Pernambuco, Brazil
Hospital Naval Marcílio Dias
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Onofre Lopes
Natal, Rio Grande do Norte, Brazil
Hospital de Pronto Socorro
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Santa Cruz
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Santa Casa de Misericórdia de Barretos
Barretos, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Bruno M Tomazini
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Tomazini BM, Nassar AP Jr, Lisboa TC, Azevedo LCP, Veiga VC, Catarino DGM, Fogazzi DV, Arns B, Piastrelli FT, Dietrich C, Negrelli KL, Jesuino IA, Reis LFL, Mattos RR, Pinheiro CCG, Luz MN, Spadoni CCDS, Moro EE, Bueno FR, Sampaio CSJC, Silva DP, Baldassare FP, Silva ACA, Veiga T, Barbante L, Lambauer M, Campos VB, Santos E, Santos RHN, Laranjeiras LN, Valeis N, Santucci E, Miranda TA, Patrocinio ACLD, Carvalho A, Sousa EMC, Sousa AHF, Malheiro DT, Bezerra IL, Rodrigues MB, Malicia JC, Silva SSD, Gimenes BDP, Sesin GP, Zavascki AP, Sganzerla D, Medeiros GS, Santos RDRMD, Silva FKR, Cheno MY, Abrahao CF, Oliveira Junior HA, Rocha LL, Nunes Neto PA, Pereira VC, Paciencia LEM, Bueno ES, Caser EB, Ribeiro LZ, Fernandes CCF, Garcia JM, Silva VFF, Santos AJD, Machado FR, Souza MA, Ferronato BR, Urbano HCA, Moreira DCA, Souza-Dantas VC, Duarte DM, Coelho J, Figueiredo RC, Foreque F, Romano TG, Cubos D, Spirale VM, Nogueira RS, Maia IS, Zandonai CL, Lovato WJ, Cerantola RB, Toledo TGP, Tomba PO, Almeida JR, Sanches LC, Pierini L, Cunha M, Sousa MT, Azevedo B, Dal-Pizzol F, Damasio DC, Bainy MP, Beduhn DAV, Jatoba JDVN, Moura MTF, Rego LRM, Silva AVD, Oliveira LP, Sodre Filho ES, Santos SSD, Neves IL, Leao VCA, Paes JLL, Silva MCM, Oliveira CD, Santiago RCB, Paranhos JLDR, Wiermann IGDS, Pedroso DFF, Sawada PY, Prestes RM, Nascimento GC, Grion CMC, Carrilho CMDM, Dantas RLAM, Silva EP, Silva ACD, Oliveira SMB, Golin NA, Tregnago R, Lima VP, Silva KGND, Boschi E, Buffon V, Machado AS, Capeletti L, Foernges RB, Carvalho AS, Oliveira Junior LC, Oliveira DC, Silva EM, Ribeiro J, Pereira FC, Salgado FB, Deutschendorf C, Silva CFD, Gobatto ALN, Oliveira CB, Dracoulakis MDA, Alvaia NOS, Souza RM, Araujo LLC, Melo RMV, Passos LCS, Vidal CFL, Rodrigues FLA, Kurtz P, Shinotsuka CR, Tavares MB, Santana IDV, Gavinho LMDS, Nascimento AB, Pereira AJ, Cavalcanti AB. IMPACTO-MR: a Brazilian nationwide platform study to assess infections and multidrug resistance in intensive care units. Rev Bras Ter Intensiva. 2022 Oct-Dec;34(4):418-425. doi: 10.5935/0103-507X.20220209-pt. Epub 2023 Mar 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
85063424.0.1001.5461
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.