{ "FullStudy":{ "Rank":217578, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519570", "OrgStudyIdInfo":{ "OrgStudyId":"2010H0290" }, "Organization":{ "OrgFullName":"Ohio State University", "OrgClass":"OTHER" }, "BriefTitle":"Use of an Electronic Medical Record in the Primary Care Setting to Improve Herpes Zoster Vaccination Rates", "OfficialTitle":"Use of an Electronic Medical Record to Improve Standard Practice in the Primary Care Setting: A Randomized-Controlled Study of Herpes Zoster Vaccination Rates" }, "StatusModule":{ "StatusVerifiedDate":"August 2018", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 12, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 27, 2018", "ResultsFirstSubmitQCDate":"August 27, 2018", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"February 1, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"August 27, 2018", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 1, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Stuart Beatty", "ResponsiblePartyInvestigatorTitle":"Assistant Professor", "ResponsiblePartyInvestigatorAffiliation":"Ohio State University" }, "LeadSponsor":{ "LeadSponsorName":"Ohio State University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Despite the significant benefits of herpes zoster vaccine (HZV), vaccination rates remain low. Electronic medical records (EMR) can serve as a practical strategy to better facilitate the application of preventative health care, such as increasing immunization rates. A new care model that can increase the herpes zoster vaccination rate, as well as other preventative health services, is warranted. The objective of this study is to investigate if the functions of an EMR, in combination with a pharmacist as part of the care team, can improve the herpes zoster vaccination rate." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Herpes Zoster Disease" ] }, "KeywordList":{ "Keyword":[ "Herpes Zoster vaccine", "Electronic patient portal", "Electronic medical record", "Primary care", "Immunizations" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Health Services Research", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"2589", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"An informational packet regarding shingles and the HZV", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: An informational packet regarding shingles and the HZV was sent to patients identified by the EMR" ] } },{ "ArmGroupLabel":"Standard medical care from their primary care physician", "ArmGroupType":"No Intervention" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"An informational packet regarding shingles and the HZV was sent to patients identified by the EMR", "InterventionDescription":"The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "An informational packet regarding shingles and the HZV" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of Participants Who Received the Herpes Zoster Vaccine", "PrimaryOutcomeDescription":"Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.", "PrimaryOutcomeTimeFrame":"6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email", "SecondaryOutcomeDescription":"Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"Amount of Time Required by a Clinical Pharmacist to Manage This Workflow", "SecondaryOutcomeTimeFrame":"6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nGreater than 60 years of age\n\nExclusion Criteria:\n\nDocumented herpes zoster vaccine in the EMR", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"60 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Stuart J Beatty, PharmD", "OverallOfficialAffiliation":"Ohio State University", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Shelley H Otsuka, PharmD", "OverallOfficialAffiliation":"The Ohio State Univeristy", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Neeraj H Tayal, MD", "OverallOfficialAffiliation":"Ohio State University", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Kyle Porter, MAS", "OverallOfficialAffiliation":"Ohio State University", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Peter J Embi, MD, MS", "OverallOfficialAffiliation":"Ohio State University", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"The Ohio State University Martha Morehouse General Internal Medicine Clinic", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43221", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"An Informational Packet Regarding Shingles and the HZV", "FlowGroupDescription":"An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Standard Medical Care From Their Primary Care Physician" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"500" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2089" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"500" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2089" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"An Informational Packet Regarding Shingles and the HZV", "BaselineGroupDescription":"An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Standard Medical Care From Their Primary Care Physician" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"500" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"2089" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"2589" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"500" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2089" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2589" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"72.1", "BaselineMeasurementSpread":"9.4" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"73.1", "BaselineMeasurementSpread":"8.1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"72.8", "BaselineMeasurementSpread":"8.7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"265" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1174" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1439" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"235" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"915" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1150" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"500" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2089" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2589" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants Who Received the Herpes Zoster Vaccine", "OutcomeMeasureDescription":"Six months after the intervention, a second EMR report was generated to determine the change in vaccination rate of both the intervention and control groups.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"6 months", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"An Informational Packet Regarding Shingles and the HZV", "OutcomeGroupDescription":"An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Standard Medical Care From Their Primary Care Physician" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"500" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"2089" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"500" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2089" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Difference in Vaccination Rates Between Patients Who Recieved a Mailed Letter Versus a Secure Email", "OutcomeMeasureDescription":"Difference in vaccination rates between patients sent communications via US postal service (USPS) and those sent communications via electronic patient portal (EPP)", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"6 months", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Amount of Time Required by a Clinical Pharmacist to Manage This Workflow", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"6 months", "OutcomeMeasureDenomUnitsSelected":"Participants" } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"An Informational Packet Regarding Shingles and the HZV", "EventGroupDescription":"An informational packet regarding shingles and the HZV was sent to patients identified by the EMR: The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"500", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"500" },{ "EventGroupId":"EG001", "EventGroupTitle":"Standard Medical Care From Their Primary Care Physician", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"2089", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"2089" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Stuart Beatty", "PointOfContactOrganization":"The Ohio State University College of Pharmacy", "PointOfContactEMail":"beatty.52@osu.edu", "PointOfContactPhone":"6146888466" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006562", "ConditionMeshTerm":"Herpes Zoster" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000073618", "ConditionAncestorTerm":"Varicella Zoster Virus Infection" },{ "ConditionAncestorId":"D000006566", "ConditionAncestorTerm":"Herpesviridae Infections" },{ "ConditionAncestorId":"D000004266", "ConditionAncestorTerm":"DNA Virus Infections" },{ "ConditionAncestorId":"D000014777", "ConditionAncestorTerm":"Virus Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8223", "ConditionBrowseLeafName":"Herpes Zoster", "ConditionBrowseLeafAsFound":"Herpes Zoster", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16105", "ConditionBrowseLeafName":"Virus Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4471", "ConditionBrowseLeafName":"Chickenpox", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1200", "ConditionBrowseLeafName":"Varicella Zoster Virus Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8226", "ConditionBrowseLeafName":"Herpesviridae Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6025", "ConditionBrowseLeafName":"DNA Virus Infections", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC02", "ConditionBrowseBranchName":"Viral Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" } ] } } } } } }