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

NCT07093450 | Recruiting

• 1 other identifier: 85063424.0.1001.5461
• Study Type: interventional
• Target: 9,000
• Locations: 1 country
• Sites: 9

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

Antimicrobial Stewardship; Critically Ill Intensive Care Unit Patients; Infection

Keywords

Antimicrobial stewardship; Intensive care unit; Infection; Stepped-wedge cluster trials; Hybrid effectiveness-implementation trials; Diagnostic stewardship

Outcome Measures

Primary Outcomes (1)

• 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

  14 months

Secondary Outcomes (2)

• ICU mortality rate

  14 months

• ICU length-of-stay

  14 months

Other Outcomes (8)

• Antimicrobial consumption, stratified by AWaRe WHO classification

  14 months

• Microbiological cultures collection rate

  14 months

• Microbiological cultures positivity rate

  14 months

Study Arms (2)

ICU Standard-of-care

NO INTERVENTION

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.

Educational Quality Improvement Intervention

EXPERIMENTAL

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

Interventions

Educational Quality Improvement Intervention OTHER

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.

Educational Quality Improvement Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Absence of local IRB approval
• All patients admitted to the intensive care unit
• Patients younger than 18 years-old will be excluded from individual-level analysis

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo: collaborator
• Hospital Sirio-Libanes: lead
• Hospital do Coracao: collaborator
• Hospital Israelita Albert Einstein: collaborator

Study Sites (9)

Hospital Maternidade São José

Colatina, Espírito Santo, Brazil

RECRUITING

Santa Casa de Misericórdia de Passos

Passos, Minas Gerais, Brazil

RECRUITING

Hospital Municipal de Maringá

Maringá, Paraná, Brazil

RECRUITING

Hospital Pelópidas Silveira

Recife, Pernambuco, Brazil

RECRUITING

Hospital Naval Marcílio Dias

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Hospital Onofre Lopes

Natal, Rio Grande do Norte, Brazil

RECRUITING

Hospital de Pronto Socorro

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Hospital Santa Cruz

Santa Cruz do Sul, Rio Grande do Sul, Brazil

RECRUITING

Santa Casa de Misericórdia de Barretos

Barretos, São Paulo, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 36888821 RESULT

MeSH Terms

Conditions

Infections

Study Officials

• Bruno A M P Besen, M.D., Ph.D.

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila Dietrich

CONTACT

+55 51 9723-2844; camila.dietrich@hsl.org.br

Bruno M Tomazini

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 30, 2025
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (9)