[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04987840":3,"trial-entities:NCT04987840":147,"trial-summary:NCT04987840":150},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":36,"sex":64,"minimum_age":25,"maximum_age":25,"healthy_volunteers":14,"eligibility_criteria":65,"std_ages":71,"locations":75,"central_contacts":140,"overall_officials":141,"references":145,"see_also_links":146},"NCT04987840","IRB00263269","A Multi-Center Diagnostic Stewardship Program to Improve Respiratory Culture Utilization in Critically Ill Children","ENROLLING_BY_INVITATION","2027-06-01","2026-06","2026-06-08","2021-05-01","Johns Hopkins University","OTHER",false,"The objective of this study is to evaluate implementation of diagnostic stewardship programs as a strategy to safely reduce antibiotic use, and to generate evidence and tools to support dissemination of diagnostic stewardship programs to a large and diverse group of hospitals.","The Bright STAR Collaborative, or Testing STewardship to reduce Antibiotic Resistance Collaborative, is a prospective multicenter quality improvement (QI) program with the goal of implementing diagnostic stewardship interventions to reduce bacterial culture use as a strategy to reduce antibiotic overuse. Investigators will use data collected by participating sites to determine whether reliable implementation of clinical practice guidelines for evaluation of patients can decrease antibiotic use in pediatric intensive care units. Investigators will perform a quasi-experimental study to compare outcome data in pre- and post- periods.\n\nGreater than or equal to 10 institutions will participate in this collaborative. Participating institutions will develop and implement an evidenced-based clinical decision-making tool as part of their quality improvement (QI) program in their pediatric intensive care unit (PICU).\n\nSpecific Aim 1: Evaluate whether locally devised quality improvement programs focused on diagnostic stewardship of respiratory cultures lead to a reduction in respiratory cultures and antibiotic use.\n\nSpecific Aim 2: To determine whether these quality improvement initiatives are associated with unintended consequence of patient harm such as mortality, length of stay, readmissions, ventilator associated infections, sepsis and septic shock.\n\nVariables: total respiratory culture rates, culture results, ICU length of stay, mortality rates, hospital and ICU readmission, cause of death, ventilator-associated infection\u002Fventilator-associated condition rate, sepsis, septic shock.\n\nAnalysis: The analytic approach equates to estimating and comparing the respiratory culture incidence during the \"baseline\u002Fpre-implementation\" and \"post-implementation\" periods, using a generalized linear mixed model (GLMM) assuming a Poisson distribution for the monthly number of respiratory cultures with the monthly number of ventilator days as an offset. Similar analyses will be performed for secondary outcomes.",[18,19],"Ventilator Associated Pneumonia","Tracheobronchitis",[21,22,23],"Diagnostic Stewardship","Pediatric","Respiratory Culture Test","OBSERVATIONAL",null,[],{"count":28,"type":29},15,"ESTIMATED",[],[32],{"measure":33,"description":34,"timeFrame":35},"Respiratory Culture Rate","Rate of endotracheal aspirate cultures; Change in respiratory cultures per 100 ventilator-days per month","up to 42 months",[37,40,43,46,49,52,55,58,61],{"measure":38,"description":39,"timeFrame":35},"Broad spectrum antibiotic use for ICU days >2 days","Over all use of broad spectrum antibiotics; Total antibiotic days per 1,000 patient days per quarter",{"measure":41,"description":42,"timeFrame":35},"New initiations - Broad spectrum antibiotic use for ICU days >2 days","Antibiotic days per 1,000 patient-days per month (antibiotic days starting on day 3 of ICU admission)",{"measure":44,"description":45,"timeFrame":35},"Mortality","Death per hospital total ICU admissions comparing pre and post-intervention periods",{"measure":47,"description":48,"timeFrame":35},"Length of ICU stay","Days in ICU; median number of days comparing pre and post-intervention periods",{"measure":50,"description":51,"timeFrame":35},"ICU readmission","Readmission to the ICU within 7 days of discharge. The coordinating center will measure the change in rate of readmission per total ICU admissions comparing pre and post-intervention periods",{"measure":53,"description":54,"timeFrame":35},"Hospital readmission","Readmission to hospital within 7 days of discharge. The coordinating center will measure the change in rate of hospital readmission comparing pre and post-intervention periods",{"measure":56,"description":57,"timeFrame":35},"ventilator associated infections","Defined by the following: Rate of ventilator associated infections episodes per 100 ventilator-days per month",{"measure":59,"description":60,"timeFrame":35},"Sepsis","defined by the following: International Classification of Diseases (ICD)-10 codes ; Admissions with ICD-10 coded sepsis per total ICU admissions",{"measure":62,"description":63,"timeFrame":35},"Septic shock","Defined by the following: ICD-10 codes; Admissions with ICD-10 coded septic shock per total ICU admissions","ALL",{"inclusion":66,"exclusion":68,"raw_text":70},[67],"Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs",[69],"Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs","Inclusion Criteria:\n\n* Institutions that plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs\n\nExclusion Criteria:\n\n* Institutions that do not plan to develop and implement a quality improvement program to reduce respiratory culture use in their Pediatric ICUs",[72,73,74],"CHILD","ADULT","OLDER_ADULT",[76,85,93,101,109,117,125,132],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Johns Hopkins Children's Center","Baltimore","Maryland","21287","United States",{"lat":83,"lon":84},39.29038,-76.61219,{"facility":86,"city":87,"state":88,"zip":89,"country":81,"geoPoint":90},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":91,"lon":92},42.35843,-71.05977,{"facility":94,"city":95,"state":96,"zip":97,"country":81,"geoPoint":98},"Children's Minnesota Hospital","Minneapolis","Minnesota","55404",{"lat":99,"lon":100},44.97997,-93.26384,{"facility":102,"city":103,"state":104,"zip":105,"country":81,"geoPoint":106},"Children's Hospital and Medical Center Omaha","Omaha","Nebraska","68114",{"lat":107,"lon":108},41.25626,-95.94043,{"facility":110,"city":111,"state":112,"zip":113,"country":81,"geoPoint":114},"Cleveland Clinic Children's Hospital","Cleveland","Ohio","44106",{"lat":115,"lon":116},41.4995,-81.69541,{"facility":118,"city":119,"state":120,"zip":121,"country":81,"geoPoint":122},"Le Bonheur Children's Hospital","Memphis","Tennessee","38103",{"lat":123,"lon":124},35.14953,-90.04898,{"facility":126,"city":127,"state":120,"zip":128,"country":81,"geoPoint":129},"Monroe Carell Jr. Children's Hospital","Nashville","37232",{"lat":130,"lon":131},36.16589,-86.78444,{"facility":133,"city":134,"state":135,"zip":136,"country":81,"geoPoint":137},"Dell Children's Medical Center","Austin","Texas","78723",{"lat":138,"lon":139},30.26715,-97.74306,[],[142],{"name":143,"affiliation":12,"role":144},"Aaron Milstone, MD, MHS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":148,"biomarkers":149},[21],[],{"nct_id":4,"found":151,"summary":152,"prompt_version":162},true,{"design":153,"status":154,"heading":155,"summary":156,"follow_up":157,"word_count":158,"commitments":159,"compensation":160,"drugs_mentioned":161},"This is an observational study involving at least 10 institutions, not individual patients. It is a quasi-experimental study comparing outcomes before and after quality improvement programs are implemented.","completed","Improving Respiratory Culture Use in Critically Ill Children","This study is looking at ways to safely reduce how often respiratory cultures (tests to identify germs in the lungs) are used in critically ill children. It's an observational study, meaning researchers will watch and learn from hospitals that are already trying to improve how they use these cultures. The goal is to see if these efforts can lead to less antibiotic use without harming patients. Researchers will compare information from before and after hospitals start these improvement programs. This study aims to help hospitals reduce unnecessary antibiotic use in children with conditions like Ventilator Associated Pneumonia (a lung infection from being on a breathing machine) and Tracheobronchitis (inflammation of the windpipe and bronchial tubes). The study is currently unclear on its recruitment status.","The primary endpoint, Respiratory Culture Rate, will be measured for up to 42 months.",124,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]