[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600127":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":164,"collaborators":166,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":182,"maxAge":12,"enrollmentInfo":183,"targetDuration":12,"studyType":186,"phases":187,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":38,"whyStopped":12,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Hospital Sirio-Libanes","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"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.\n\nDuring 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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Other: Educational Quality Improvement Intervention",[20],{"type":6,"name":14,"description":21,"armGroupLabels":22,"otherNames":12},"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.",[14],[24],{"name":25,"affiliation":5,"role":26},"Bruno A M P Besen, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"Camila Dietrich","CONTACT","+55 51 9723-2844","camila.dietrich@hsl.org.br",{"name":34,"role":30,"phone":12,"phoneExt":12,"email":12},"Bruno M Tomazini",[36,54,68,82,96,109,123,137,150],{"facility":37,"status":38,"city":39,"state":40,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Hospital Maternidade São José","RECRUITING","Colatina","Espírito Santo","Brazil","BR",{"type":44,"coordinates":45},"Point",[46,47],-40.63056,-19.53944,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":52,"phoneExt":12,"email":53},"Rodrigo C Figueiredo","+55 27 98898-0486","figueiredorc@hotmail.com",{"facility":55,"status":38,"city":56,"state":57,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Santa Casa de Misericórdia de Passos","Passos","Minas Gerais",{"type":44,"coordinates":59},[60,61],-46.60972,-20.71889,{"lat":61,"lon":60},[64],{"name":65,"role":30,"phone":66,"phoneExt":12,"email":67},"Priscila F N Gonçalves","+55 35 8882-9688","prifreitas@yahoo.com.br",{"facility":69,"status":38,"city":70,"state":71,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospital Municipal de Maringá","Maringá","Paraná",{"type":44,"coordinates":73},[74,75],-51.93861,-23.42528,{"lat":75,"lon":74},[78],{"name":79,"role":30,"phone":80,"phoneExt":12,"email":81},"Ana Cristina M Gurgel","+55 44 9103-5071","anacrismed@yahoo.com.br",{"facility":83,"status":38,"city":84,"state":85,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Hospital Pelópidas Silveira","Recife","Pernambuco",{"type":44,"coordinates":87},[88,89],-34.88111,-8.05389,{"lat":89,"lon":88},[92],{"name":93,"role":30,"phone":94,"phoneExt":12,"email":95},"Lívia A Medeiros","+55 81 9178-3913","liviamedeiros@hotmail.com",{"facility":97,"status":38,"city":98,"state":98,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Hospital Naval Marcílio Dias","Rio de Janeiro",{"type":44,"coordinates":100},[101,102],-43.18223,-22.90642,{"lat":102,"lon":101},[105],{"name":106,"role":30,"phone":107,"phoneExt":12,"email":108},"Vitor A Borges","+55 21 97459-7222","borges.vitor@marinha.mil.br",{"facility":110,"status":38,"city":111,"state":112,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Hospital Onofre Lopes","Natal","Rio Grande do Norte",{"type":44,"coordinates":114},[115,116],-35.20944,-5.795,{"lat":116,"lon":115},[119],{"name":120,"role":30,"phone":121,"phoneExt":12,"email":122},"Gisele R Borba","+ 55 84 8144-8666","gisele.borba@ebserh.gov.br",{"facility":124,"status":38,"city":125,"state":126,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Hospital de Pronto Socorro","Porto Alegre","Rio Grande do Sul",{"type":44,"coordinates":128},[129,130],-51.23019,-30.03283,{"lat":130,"lon":129},[133],{"name":134,"role":30,"phone":135,"phoneExt":12,"email":136},"Cristiano A Franke","+55 51 9933-0031","cristianofranke@gmail.com",{"facility":138,"status":38,"city":139,"state":126,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Hospital Santa Cruz","Santa Cruz do Sul",{"type":44,"coordinates":141},[142,143],-52.42583,-29.7175,{"lat":143,"lon":142},[146],{"name":147,"role":30,"phone":148,"phoneExt":12,"email":149},"Maitê S Magdalena","+55 51 9737-4979","maitemagdalena@unisc.br",{"facility":151,"status":38,"city":152,"state":153,"zip":12,"country":41,"countryCode":42,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Santa Casa de Misericórdia de Barretos","Barretos","São Paulo",{"type":44,"coordinates":155},[156,157],-48.56778,-20.55722,{"lat":157,"lon":156},[160],{"name":161,"role":30,"phone":162,"phoneExt":12,"email":163},"Isaac F D Favaro","+55 17 98119-7004","isaacdelfavero@hotmail.com",{"type":165,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[167,169,171],{"name":168,"class":6},"Hospital do Coracao",{"name":170,"class":6},"Hospital Israelita Albert Einstein",{"name":172,"class":6},"Beneficência Portuguesa de São Paulo","100600127","quality-improvement-intervention-for-a-safe-antimicrobial-use-reduction-in-critically-ill-patients-100600127",false,"NCT07093450","Quality Improvement Intervention for a Safe Antimicrobial Use Reduction in Critically Ill Patients","Estudo de Implementação de Melhoria de Qualidade Para Redução do Uso de Antimicrobianos em Unidades de Terapia Intensiva","SAFE-REDUCE","Intensive care units inclusion Criteria:\n\n* ICU leadership acceptance to participant in the quality improvement intervention;\n* Hospital infection control leadership acceptance to participant in the quality improvement intervention;\n* ICU participation in the IMPACTO-MR platform with high quality data;\n* ICU potential for quality improvement based on a subjective assessment of the ICU and hospital infection leaderships\n\nIntensive care units exclusion Criteria:\n\n\\- Absence of local IRB approval\n\nParticipants inclusion Criteria:\n\n* All patients admitted to the intensive care unit\n\nParticipants exclusion Criteria:\n\n* Patients younger than 18 years-old will be excluded from individual-level analysis","ALL","18 Years",{"count":184,"type":185},9000,"ESTIMATED","INTERVENTIONAL",[188],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does the educational intervention reduce the antimicrobial consumption in the intensive care units?\n* 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?\n\nResearchers 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.\n\nEach 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.",[191,192,193],"Infection","Antimicrobial Stewardship","Critically Ill Intensive Care Unit Patients",[195,196,191,197,198,199],"Antimicrobial stewardship","Intensive care unit","Stepped-wedge cluster trials","Hybrid effectiveness-implementation trials","Diagnostic stewardship","2025-11-25",{"date":202,"type":203},"2025-12-03","ACTUAL",{"date":205,"type":203},"2025-06-01",{"date":207,"type":185},"2026-07",{"name":5,"class":6},9]