{
  "FullStudy":{
    "Rank":217999,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514071",
          "OrgStudyIdInfo":{
            "OrgStudyId":"1103-040"
          },
          "Organization":{
            "OrgFullName":"Children's Hospitals and Clinics of Minnesota",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Animated Picture to Improve Provider Adherence to CT Scan for Head Injury Rule"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 30, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 31, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Children's Hospitals and Clinics of Minnesota",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"It is difficult for Pediatric Emergency Department providers to recognize clinically significant head injuries that are likely to require neurosurgical intervention or close monitoring from those that can be safely discharged.\n\nResearch Question How do a combination of education and an animated picture depicting the PECARN CT Head Injury rules impact compliance to these rules and reduce unnecessary head CT scans?\n\nDesign This is a within subject, repeated measures study design."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Minor Head Injury"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "head injury",
              "CT",
              "emergency",
              "radiation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"746",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Pop-up picture",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Pop-up picture"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Pop-up picture",
                "InterventionDescription":"An animated picture depicting the key elements of the PECARN CT scan head injury rules will be explained. The picture will \"pop-up\" when a provider selects the order set for a CT scan due to head injury. Providers will need to select a box stating the patient either \"meets criteria\" or \"does not meet criteria\" in order to close the animated picture window.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Pop-up picture"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Compliance to the PECARN CT Scan Head Injury rules",
                "PrimaryOutcomeTimeFrame":"3 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Decreased rate of CT scans",
                "SecondaryOutcomeTimeFrame":"3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients presenting to Children's ED will be included if they:\nAre between 0 and 18 years of age (inclusive)\nReceive a discharge diagnosis of head injury\nPresent to the ED within 24 hours of the head injury\nGCS of 14 or greater\n\nExclusion Criteria:\n\nPatients will be excluded if they :\nHad a CT scans done in an outside transferring institution\nHave obvious penetrating head injuries\nHad a trivial injury mechanisms such as ground-level falls or walking or running into stationary objects\nHave no signs or symptoms of head trauma other than scalp abrasions and lacerations.\nHave known brain tumors, pre-existing neurological disorders complicating assessment, ventricular shunts, bleeding disorders",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Children's Hospitals and Clinics of Minnesota",
                "LocationCity":"Minneapolis",
                "LocationState":"Minnesota",
                "LocationZip":"55404",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Children's Hospitals and Clinics of Minnesota",
                "LocationCity":"Twin Cities",
                "LocationState":"Minnesota",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"19758692",
                "ReferenceType":"background",
                "ReferenceCitation":"Kuppermann N, Holmes JF, Dayan PS, Hoyle JD Jr, Atabaki SM, Holubkov R, Nadel FM, Monroe D, Stanley RM, Borgialli DA, Badawy MK, Schunk JE, Quayle KS, Mahajan P, Lichenstein R, Lillis KA, Tunik MG, Jacobs ES, Callahan JM, Gorelick MH, Glass TF, Lee LK, Bachman MC, Cooper A, Powell EC, Gerardi MJ, Melville KA, Muizelaar JP, Wisner DH, Zuspan SJ, Dean JM, Wootton-Gorges SL; Pediatric Emergency Care Applied Research Network (PECARN). Identification of children at very low risk of clinically-important brain injuries after head trauma: a prospective cohort study. Lancet. 2009 Oct 3;374(9696):1160-70. doi: 10.1016/S0140-6736(09)61558-0. Epub 2009 Sep 14. Erratum in: Lancet. 2014 Jan 25;383(9914):308."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000006259",
                "ConditionMeshTerm":"Craniocerebral Trauma"
              },{
                "ConditionMeshId":"D000014947",
                "ConditionMeshTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000020196",
                "ConditionAncestorTerm":"Trauma, Nervous System"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6379",
                "ConditionBrowseLeafName":"Emergencies",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7932",
                "ConditionBrowseLeafName":"Craniocerebral Trauma",
                "ConditionBrowseLeafAsFound":"Head Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafAsFound":"Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20607",
                "ConditionBrowseLeafName":"Trauma, Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              }
            ]
          }
        }
      }
    }
  }
}