[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509981":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":59,"collaborators":24,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":24,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":87,"whyStopped":24,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","The INTEGO practices (INTEGO is a GP morbidity registry in Flanders Belgium) that will be assigned to the intervention group will receive an extended electronic feedback report with multiple components, directly implemented in their EHR (electronic health record), on the pneumococcal vaccination coverage in adults at risk in their practice ('push system'). There will be a direct connection between the EHR of the practice and a SAS visual analytics tool in the Healthdata environment (single-sign-on connection), that will show the extended feedback. This report will be available at baseline and updated every two months based on the current situation.",[13],"Other: AUDIT and Feedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Every GP center assigned to the control group will only have access to the clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. GP centers in the control group will not receive an extended feedback report at baseline and every 2 months afterwards.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"AUDIT and Feedback","AUDIT and Feedback is a well-known quality intervention that according to the last Cochrane review leads to \"small but potentially important improvements in professional practice\" (Ivers N et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012, 6:Cd000259).\n\nStandardized automated AUDITs are available in most EHR systems in Belgium. Feedback, on the other hand, is only available in specific registration networks. At study baseline the performance in INTEGO practices will be measured. Afterwards a standardized clinical AUDIT to identify patients that may benefit from pneumococcal vaccination will be implemented in the EHR of all INTEGO practices. The Feedback will only be implemented in the intervention group.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Bert Vaes, MD, PhD","Department of Public Health and Primary Care, KU Leuven","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+32 16 37 72 97","bert.vaes@kuleuven.be",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Arne Janssens, Msc","+32 16 37 66 21","arne.janssens@kuleuven.be",[40],{"facility":41,"status":24,"city":42,"state":24,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Academic Center of General Practice","Leuven","3000","Belgium","BE",{"type":47,"coordinates":48},"Point",[49,50],4.70093,50.87959,{"lat":50,"lon":49},[53,56],{"name":54,"role":32,"phone":37,"phoneExt":24,"email":55},"Tine De Burghgraeve, PhD","tine.deburghgraeve@kuleuven.be",{"name":57,"role":32,"phone":37,"phoneExt":24,"email":58},"Margriet de Jong","margriet.dejong@kuleuven.be",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Bert Vaes","Associate Professor","100509981","the-effect-of-audit-and-feedback-on-pneumococcal-vaccination-coverage-100509981",false,"NCT05920499","The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage","The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage in Adults At Risk in General Practice: a Cluster Randomized Trial","Inclusion Criteria\n\n* To be eligible for inclusion in the study, general practice (GP) centers must conform to the following conditions:\n\n  1. It is a Flemish GP center in the INTEGO network.\n  2. The GP center uses an electronic health record (EHR), automatically linked to the INTEGO database.\n  3. The physician (one per center, in name of all GPs in that center) signs a specific study consent form.\n* To be eligible for inclusion in the study, patients must conform to the following conditions:\n\n  1. The patient belongs to a target group for pneumococcal vaccination (based on https:\u002F\u002Fwww.health.belgium.be\u002Fsites\u002Fdefault\u002Ffiles\u002Fuploads\u002Ffields\u002Ffpshealth\\_theme\\_file\u002Fhgr\\_9562\\_vaccinatie\\_tegen\\_pneumokokken\\_vweb.pdf):\n\n     A. Adults aged 16 - 85 years old with a high risk for a pneumococcal infection\n     * Adults with an immunity disorder\n     * Adults with anatomical and \u002F or functional asplenia, sickle-cell disease or hemoglobinopathy\n     * Adults with cerebrospinal fluid or cochlear implant leakage B. Adults (aged 50 - 85 years old) with comorbidity\n     * Chronic cardiac disease\n     * Chronic pulmonary disease or smoker\n     * Chronic liver disease or ethylabusus\n     * Chronic kidney disease\n     * Chronic neurological or neuromuscular disorders with aspiration risk\n     * Diabetes mellitus C. Healthy persons aged 65 - 85 years old\n  2. The patient has an electronic medical record (EMR) in the participating general practice centre. This EMR contains all the patient information, for instance regarding medical history and medication and is managed by the general practitioner.\n\nExclusion criteria\n\n* Patients excluded from feedback: patients not belonging to one of the target groups for pneumococcal vaccination.\n* Patients excluded from AUDIT: patients not belonging to one of the target groups for pneumococcal vaccination OR\n\n  * Correctly vaccinated high-risk patients (PPV23 less than 5 years ago AND PCV13 ever received)\n  * Correctly vaccinated adults with comorbidity (1) PCV13 ever received AND PPV23 less than 5 years ago, OR 2) PCV13 ever received AND 2x PPV23 vaccination more than 5 years ago)\n  * Correctly vaccinated healthy persons (PPV23 ever received)","ALL","16 Years","85 Years",{"count":74,"type":75},36,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this cluster-randomized trial is to study the effect of Audit and Feedback loops on pneumococcal vaccination coverage rate in adults at risk in general practice.\n\nThe main questions it aims to answer are:\n\n* To assess the effect of \"clinical AUDIT and feedback\" loops on the pneumococcal vaccination coverage rate in adults at risk in general practice.\n* To explore whether the increase in vaccination coverage rate after implementation of Audit and Feedback loops is different in specific subgroups (risk groups, male\u002Ffemale, age, smoking status).\n\nEvery general practice center assigned to the control or intervention group will have access to a clinical AUDIT to identify patients that may benefit from a pneumococcal vaccination. The general practice centers in the intervention group will also receive an individualized extended electronic feedback report, with multiple components like benchmarked performances and action plans, at baseline and each 2 months from baseline onwards.",[81],"Pneumococcal Infections",[83,84,85,86],"AUDIT","Feedback","general practice","pneumococcal vaccination rate","NOT_YET_RECRUITING","2024-09-21",{"date":90,"type":91},"2024-09-24","ACTUAL",{"date":93,"type":75},"2025-01-31",{"date":95,"type":75},"2026-03-31",{"name":61,"class":6},1]