[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529030":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":117,"collaborators":120,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":25,"maxAge":25,"enrollmentInfo":132,"targetDuration":25,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Sunnybrook Health Sciences Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Simplified layered consent process","EXPERIMENTAL","For participants randomized to the SIMPLY-SNAP experimental group, a simplified layered consent process will be used to explain information for the SNAP trial. The research staff member obtaining consent will provide a standardized explanation, providing summarized information in simple English or French contained in a 4-page concise participant information sheet. Throughout the consent process, the research staff member will answer any questions that the participant has, to reflect routine consent discussion practice.",[13],"Other: Simplified layered consent form",{"label":15,"type":16,"description":17,"interventionNames":18},"Full-length consent form","ACTIVE_COMPARATOR","For participants randomized to the control group, the existing consent process will be used including going through the currently approved full-length informed consent form. The research staff member will provide an explanation using the full-length informed consent form as per standard clinical trial procedures. Similarly, throughout the consent process, the research staff member will answer any participant questions as per normal procedures.",[19],"Other: Full-length consent form",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Simplified layered consent form","The simplified consent form includes all essential elements of trial consent including an explanation of the trial procedures, data and sample collection, and follow-up information. The form also outlines important ethical considerations for patients, such as confidentiality, regulatory and safety requirements, the ability to drop out, and the necessary process and contact numbers for grievances or feedback. In addition to the text, the form includes links to additional written information and videos that can be accessed on top of the simplified informed consent form (i.e., the additional layers in the layered consent process). These materials are hosted on the main SNAP trial website (https:\u002F\u002Fwww.snaptrial.com.au\u002Fpatients) and are available in English and French. Participants will be able to access these directly through embedded hyperlinks using provided electronic tablets.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The full-length informed consent form contains all information upfront. Links to additional information will not be provided on the form but are freely available on the Internet should the participant wish to access them.",[15],[30],{"name":31,"affiliation":32,"role":33},"Sean WX Ong, MBBS","University of Toronto","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","4164806100","2791","s.ong@mail.utoronto.ca",[41,57,69,80,95,107],{"facility":42,"status":43,"city":44,"state":45,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Calgary, Foothills Medical Centre, Peter Lougheed Centre, Rockyview Hospital, South Health Campus","RECRUITING","Calgary","Alberta","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-114.08529,51.05011,{"lat":52,"lon":51},[55],{"name":56,"role":36,"phone":25,"phoneExt":25,"email":25},"Ranjani Somayaji",{"facility":58,"status":43,"city":59,"state":60,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Hamilton General Hospital","Hamilton","Ontario",{"type":49,"coordinates":62},[63,64],-79.84963,43.25011,{"lat":64,"lon":63},[67],{"name":68,"role":36,"phone":25,"phoneExt":25,"email":25},"Dominik Mertz, MD",{"facility":70,"status":43,"city":71,"state":60,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"The Ottawa Hospital","Ottawa",{"type":49,"coordinates":73},[74,75],-75.69812,45.41117,{"lat":75,"lon":74},[78],{"name":79,"role":36,"phone":25,"phoneExt":25,"email":25},"Derek McFadden, MD",{"facility":5,"status":43,"city":81,"state":60,"zip":82,"country":46,"countryCode":47,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Toronto","M4N3M5",{"type":49,"coordinates":84},[85,86],-79.39864,43.70643,{"lat":86,"lon":85},[89,92],{"name":90,"role":36,"phone":37,"phoneExt":38,"email":91},"Nick Daneman, MD","nick.daneman@sunnybrook.ca",{"name":93,"role":94,"phone":25,"phoneExt":25,"email":25},"Rob A Fowler, MD","SUB_INVESTIGATOR",{"facility":96,"status":43,"city":97,"state":98,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Montreal General Hospital","Montreal","Quebec",{"type":49,"coordinates":100},[101,102],-73.58781,45.50884,{"lat":102,"lon":101},[105],{"name":106,"role":36,"phone":25,"phoneExt":25,"email":25},"Todd Lee, MD",{"facility":108,"status":43,"city":109,"state":98,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Royal Victoria Hospital","Québec",{"type":49,"coordinates":111},[112,113],-71.21454,46.81228,{"lat":113,"lon":112},[116],{"name":106,"role":36,"phone":25,"phoneExt":25,"email":25},{"type":33,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Sean Ong","Research Associate, Evaluative Clinical Sciences",[121],{"name":122,"class":6},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","100529030","evaluating-simplified-layered-consent-for-clinical-trials-100529030",false,"NCT06168474","Evaluating Simplified Layered Consent for Clinical Trials","Evaluating the Impact of a SIMPlified LaYered Consent Process on Recruitment of Potential Participants to the Staphylococcus Aureus Network Adaptive Platform Trial: a Pragmatic Nested Randomized Clinical Trial","SIMPLY-SNAP","Inclusion Criteria:\n\n* All inclusion criteria from the larger SNAP trial:\n\n  1. S. aureus complex grown from ≥1 blood culture\n  2. Admitted to a participating hospital at the time of eligibility assessment\n* Specific additional inclusion criteria for SIMPLY-SNAP:\n\n  1. Admitted to participating hospital of SIMPLY-SNAP\n  2. Self-reported proficiency in English or French adequate to be able to participate in consent process carried out solely in English or French (as the supplementary consent materials required in the simplified consent process are currently only available in these two languages)\n\nExclusion Criteria:\n\n* All exclusion criteria from larger SNAP trial:\n\n  1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture\n  2. Polymicrobial bacteremia, defined as more than one organism in the index blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician\n  3. Patient currently being treated with a systemic antibacterial agent that cannot be ceased\n  4. Known previous participation in SNAP\n  5. Known positive blood culture for S. aureus between 72 hours and 180 days prior to the time of eligibility assessment\n  6. Treating team deems enrolment in the study is not in the best interest of the patient\n  7. Treating team believes that death is imminent and inevitable\n  8. Patient is for end-of-life care and antibiotic treatment is considered inappropriate\n  9. Patient \\\u003C18 years of age and paediatric recruitment not approved at recruiting site\n* Specific additional exclusion criteria for SIMPLY-SNAP: None","ALL",{"count":133,"type":134},346,"ESTIMATED","INTERVENTIONAL",[137],"NA","The goal of this clinical trial (the SIMPLY-SNAP trial) is to compare a simplified layered consent form to a full-length consent form for use during the informed consent process for a larger clinical trial of treatment of Staphylococcus aureus bloodstream infection (the SNAP trial).\n\nThe main questions it aims to answer are:\n\n* Does use of a simplified layered consent form lead to an increased recruitment rate to the SNAP trial?\n* Does use of a simplified layer consent form lead to increased participant understanding of the SNAP trial and increased participant satisfaction with the informed consent process?\n\nParticipants will be randomized to either the full-length informed consent form or the simplified layered consent form containing links to optional supplementary information or videos. Research staff will use the assigned form to explain the SNAP trial to participants. After consent, participants will be evaluated on their understanding of the SNAP trial and satisfaction with the consent process using a questionnaire.",[140],"Staphylococcus Aureus Bacteremia",[142,143,144,145,146],"informed consent","research ethics","clinical trials","Staphylococcus aureus bacteremia","equity, diversity and inclusion","2025-05-12",{"date":149,"type":150},"2025-05-15","ACTUAL",{"date":152,"type":150},"2023-11-28",{"date":154,"type":134},"2026-06",{"name":5,"class":6},6]