Nctid:
NCT06612619
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000005264", "term"=>"Femoral Fractures"}], "ancestors"=>[{"id"=>"D000050723", "term"=>"Fractures, Bone"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000007869", "term"=>"Leg Injuries"}], "browseLeaves"=>[{"id"=>"M26370", "name"=>"Fractures, Bone", "relevance"=>"LOW"}, {"id"=>"M8402", "name"=>"Femoral Fractures", "asFound"=>"Femoral Fractures", "relevance"=>"HIGH"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}, {"id"=>"M10881", "name"=>"Leg Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M7167", "name"=>"Diazepam", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Adjuvants, Anesthesia", "abbrev"=>"AdjAn"}, {"name"=>"Anticonvulsants", "abbrev"=>"AntiConv"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Muscle Relaxants, Central", "abbrev"=>"MuRelCen"}, {"name"=>"Psychotropic Drugs", "abbrev"=>"PsychDr"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-09-24", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-11-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2024-09-16", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Number of two-hour self-trainin sessions to achieve mastery standard", "timeFrame"=>"From enrollment to mastery standard achieved. This will vary, but there's a time cap of 10 weeks", "description"=>"The embeeded test in the simulator has established mastery standards. The primary outcome is how many two hour training sessions the trainees has to attend to achieve the mastery standard"}], "secondaryOutcomes"=>[{"measure"=>"Hands-on training time", "timeFrame"=>"10 weeks", "description"=>"The hands-on time the trainee is actively training on the simulator"}, {"measure"=>"Test score of each iteration of training", "timeFrame"=>"10 weeks", "description"=>"Test scores for each iteration of training until the trainee achieves the mastery standard"}, {"measure"=>"Failure to achieve mastery standard", "timeFrame"=>"10 weeks", "description"=>"Number of participants not achieving the mastery standard within 10 weeks from enrollment"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Simulation-based training", "Mastery standards", "Proximal femoral fracture", "Medical Education", "Osteosynthesis", "Orthopeadic surgery", "Dyad instruction"], "conditions"=>["Learning Curves and Outcomes of Simulation-based Training"]}, "descriptionModule"=>{"briefSummary"=>"The training of orthopedic surgeons has historically relied heavily on an apprenticeship model as the primary way of teaching the various procedures an aspiring surgeon needs to master. However, due to work-hour restrictions, demand for operating room efficiency, lack of supervisors and a growing focus and concern for patient safety, this model is challenged. As the importance of proper education and supervision of surgeons in training is still monumental, simulation-based training (SBT) has gained popularity within most medical specialties, as it provides a safe, and realistic room for training, where surgeons can effectively enhance their operating technique without posing a threat to patient safety. Techniques within orthopedic surgery are no exception to this tendency, and several virtual reality simulators and SBT courses has been developed. This includes the well-established SBT course in proximal femoral fracture (PFF) osteosynthesis, where evidence supported mastery standards for antegrade nailing, dynamic hip screw, Hansson pins and canulated screws have been established. A course that is recommended in the national curriculum for Danish orthopedic surgeons in training.\n\nThis change into a more technology- and simulation-based training does however pose challenges, that needs to be acknowledged and addressed to ensure the quality of the education and clinical skills of the orthopedic surgeons.\n\nA key challenge is the limited resource of qualified instructors. These instructors are mainly experienced surgeons with a demanding and busy schedule, who teach part time in addition to their clinical work. It has previously been shown that teaching skills are to be taught by doctors and that good clinicians are not automatically good educators. With the burden of a busy clinical schedule, these experienced surgeons have difficulties finding the time to learn teaching skills.\n\nIt can therefore be challenging to educate enough qualified instructors. This poses a rising concern as the field of SBT is only expected to grow, with more courses in continuous development. Thus, potentially limiting the accessibility to orthopedic SBT courses, including the PFF course.\n\nA possible solution for this challenge is dyad introductions. By converting one-on-one introduction to SBT for trainees into one-on-two introduction, it is possible to double the number of participants getting introductions without increasing the teaching load or expenses. This could significantly reduce the needed faculty time per trainee. Several studies have shown beneficial learning outcomes of dyad training. However, it seems, that the positive effects of dyad training cannot be translated into all types of medical simulations, and some studies suggests that the complexity and nature of the simulation defines whether dyad training is beneficial . It is theorized, that the effect of dyad training is caused by the learning of motor skills through mirror neurons during observation, and the distribution of knowledge during complex simulations according to the cognitive load theory. This suggests, that dyad training may be most beneficial in complex simulations requiring high levels of motor skills such as complex surgical procedures.\n\nTo our knowledge, no studies exist that examines whether dyad introduction can be equally used in the simulations of orthopedic procedures in general or PFF surgery specifically.\n\nThe aim of this study was to examine whether dyad introduction is non-inferior to the current one-on- one student introduction."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* PGY 1 and 2 doctors working in an orthopeadic department\n\nExclusion Criteria:\n\n* More than 10 osteosynthesis of proximal femoral fractures performed as the primary surgeon.\n* Not having read the preparational documents prior to instruction\n* Failure to achieve the mastery standard within 10 weeks"}, "identificationModule"=>{"nctId"=>"NCT06612619", "briefTitle"=>"Is Two-on-one Instruction in Virtual Reality Simulation-based Training of Operating Fractures of the Hip for Medical Students As Effective As One-on-one Instruction", "organization"=>{"class"=>"OTHER", "fullName"=>"Copenhagen Academy for Medical Education and Simulation"}, "officialTitle"=>"Dyad Versus Single Instruction for Simulation-based Training in Proximal Femoral Fracture Osteosynthesis: a Non-inferiority Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"F-24056399"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"One-on-one instruction to simulation-based training", "description"=>"The usual instruction with one instructor instructing the trainee in simulation-based training in osteosynthesis of proximal femoral fractures"}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Dyad instruction", "description"=>"Dyad or two-on-one instruction, where two trainees are instructed by an instructor at the same time and with the same time usage as in the non-intervention arm.", "interventionNames"=>["Behavioral: Dyad instruction"]}], "interventions"=>[{"name"=>"Dyad instruction", "type"=>"BEHAVIORAL", "description"=>"Rather than being instructed solo or one-on-one the trainees are instructed in pairs of two (dyad).", "armGroupLabels"=>["Dyad instruction"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"2100", "city"=>"Copenhagen", "country"=>"Denmark", "contacts"=>[{"name"=>"Amanuds Gustafsson, MD, PhD", "role"=>"CONTACT", "email"=>"amandus.gustafsson.02@regionh.dk", "phone"=>"4526792011"}, {"name"=>"Mads E Jacobsen, MD", "role"=>"CONTACT", "email"=>"mads.emil.jacobsen@regionh.dk"}, {"name"=>"Mikkel ES Nielsen, Medical Student", "role"=>"CONTACT"}], "facility"=>"Copenhagen Academy for Medical Education and Simulation", "geoPoint"=>{"lat"=>55.67594, "lon"=>12.56553}}], "centralContacts"=>[{"name"=>"Amandus Gustafsson, MD, PhD", "role"=>"CONTACT", "email"=>"amandus.gustafsson.02@regionh.dk", "phone"=>"4526792011"}, {"name"=>"Mads E Jacobsen, MD", "role"=>"CONTACT", "email"=>"mads.emil.jacobsen@regionh.dk", "phone"=>"4560777357"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED", "description"=>"We will only share IPD based on a specific request or by demand of a journal"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Copenhagen Academy for Medical Education and Simulation", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate Professor, MD, PhD", "investigatorFullName"=>"Amandus Gustafsson", "investigatorAffiliation"=>"Copenhagen Academy for Medical Education and Simulation"}}}}
