[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475518":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":34,"centralContacts":41,"locations":51,"responsibleParty":104,"collaborators":106,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":21,"enrollmentInfo":121,"targetDuration":21,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":54,"whyStopped":21,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Quality Improvement Program","The quality improvement program will consist of development and\u002For refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.",[12,13,14,15],"Other: Multidisciplinary Team","Other: Outreach Visits","Other: Multifaceted Intervention","Other: Measurement and Feedback",[17,22,26,30],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"Multidisciplinary Team","Multidisciplinary team will be established that will define gaps in care, monitor ongoing data, identify barriers to guideline-directed care, and develop and implement multifaceted intervention to address the barriers",[9],null,{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Outreach Visits","An outreach visit consulting group from the coordinating center and trial leadership will provide external guidance on reviewing data, defining barriers, and implementing interventions",[9],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":21},"Multifaceted Intervention","These interventions are not limited to targeted engagement with non-extractors, electronic health record (EHR) decision support, creation of OR block time, use of opinion leaders, and development of clinical pathways. In addition, once patients are identified and referred to extraction centers, clinical pathways are needed to provide prompt care without clinical delay",[9],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":21},"Measurement and Feedback","The coordinating center will provide ongoing feedback related to the site's data. This will include time to diagnosis, treatment, and outcomes related to the device infection.",[9],[35,39],{"name":36,"affiliation":37,"role":38},"Chris Granger, MD","Duke Clinical Research Institute","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":37,"role":38},"Sean Pokorney, MD",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":21,"email":46},"Kimberly Ward, MPH","CONTACT","9196606409","kimberly.t.ward@duke.edu",{"name":48,"role":44,"phone":49,"phoneExt":21,"email":50},"Sarah Brady","9196818928","sarah.brady@duke.edu",[52,71,91],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Northwestern","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-87.65005,41.85003,{"lat":64,"lon":63},[67,69],{"name":68,"role":44,"phone":21,"phoneExt":21,"email":21},"Anna Huskin, RN, BSN",{"name":70,"role":38,"phone":21,"phoneExt":21,"email":21},"Albert Lin, MD",{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":58,"countryCode":59,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Atrium Health","NOT_YET_RECRUITING","Charlotte","North Carolina","28203",{"type":61,"coordinates":78},[79,80],-80.84313,35.22709,{"lat":80,"lon":79},[83,85,87,89],{"name":84,"role":44,"phone":21,"phoneExt":21,"email":21},"Melissa Myers",{"name":86,"role":44,"phone":21,"phoneExt":21,"email":21},"Nicole Boisvert",{"name":88,"role":38,"phone":21,"phoneExt":21,"email":21},"Rohit Mehta, MD",{"name":90,"role":38,"phone":21,"phoneExt":21,"email":21},"Satish Misra, MD",{"facility":92,"status":73,"city":93,"state":75,"zip":94,"country":58,"countryCode":59,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Moses Cone","Greensboro","27401",{"type":61,"coordinates":96},[97,98],-79.79198,36.07264,{"lat":98,"lon":97},[101,103],{"name":102,"role":44,"phone":21,"phoneExt":21,"email":21},"Cameron Lambert, MD",{"name":102,"role":38,"phone":21,"phoneExt":21,"email":21},{"type":105,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[107,108],{"name":37,"class":6},{"name":109,"class":110},"Philips Healthcare","INDUSTRY","100475518","cied-infection-quality-initiative-demonstration-project-100475518",false,"NCT05471973","CIED Infection Quality Initiative Demonstration Project","The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project","RECTIFY","Inclusion Criteria:\n\n* Age ≥18 years\n* Cardiovascular Implantable Electronic Device (CIED) in place\n* Presumed CIED infection, as defined by:\n\n  1. Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia\n  2. Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection\n\nExclusion Criteria:\n\n* Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and\u002For it is unlikely that extraction would change overall prognosis\n* Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection\n* Patients with left ventricular assist devices (LVADs)","ALL","18 Years",{"count":122,"type":123},200,"ESTIMATED","INTERVENTIONAL",[126],"NA","The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.",[129],"Infections",[131,132],"Cardiac Implantable Electronic Devices","Quality improvement","2026-05-04",{"date":135,"type":136},"2026-05-06","ACTUAL",{"date":138,"type":136},"2023-05-10",{"date":140,"type":123},"2027-03-31",{"name":5,"class":6},3]