{ "FullStudy":{ "Rank":217545, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519999", "OrgStudyIdInfo":{ "OrgStudyId":"HM14436" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"WISDM-106965", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Virginia Commonwealth University" } ] }, "Organization":{ "OrgFullName":"Virginia Commonwealth University", "OrgClass":"OTHER" }, "BriefTitle":"Colorectal Cancer Screening With Improved Shared Decision Making", "OfficialTitle":"Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)", "Acronym":"CRCS-WISDM" }, "StatusModule":{ "StatusVerifiedDate":"January 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 18, 2017", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 18, 2017", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 31, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"February 4, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Virginia Commonwealth University", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Allina Health System", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Blue Cross Blue Shield", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).", "DetailedDescription":"Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N~50,000 patients.\n\nCommunity engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Colorectal Cancer Screening", "Shared Decision Making" ] }, "KeywordList":{ "Keyword":[ "Shared decision making", "Ambulatory Care", "Patient-Centered Care", "Community-wide intervention", "Intervention Study", "Longitudinal Studies" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"206721", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Shared Decision Making", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Shared Decision Making for Colorectal Cancer Screening" ] } },{ "ArmGroupLabel":"Comparison (control)", "ArmGroupType":"No Intervention" } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Shared Decision Making for Colorectal Cancer Screening", "InterventionDescription":"Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Shared Decision Making" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "CRCS-WISDM" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in colorectal cancer screening adherence", "PrimaryOutcomeDescription":"Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.", "PrimaryOutcomeTimeFrame":"Baseline up to 24 months post intervention initiation" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Decisional conflict", "SecondaryOutcomeDescription":"A previously validated decisional conflict scale, will be used, which includes 16 items all measured on a 5-point Likert-type scale. (e.g. difficulty in decision making, certainty with a decision, demonstrated feeling of understanding about risks and benefits of a decision, and satisfaction with a decision). Responses will be coded so that higher responses represent greater decisional conflict.", "SecondaryOutcomeTimeFrame":"Baseline up to 24 months post intervention initiation" },{ "SecondaryOutcomeMeasure":"Modality-specific colorectal cancer screening barriers", "SecondaryOutcomeDescription":"A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement.", "SecondaryOutcomeTimeFrame":"Baseline up to 24 months post intervention initiation" },{ "SecondaryOutcomeMeasure":"Colorectal cancer screening-related confusion", "SecondaryOutcomeDescription":"Colorectal cancer-related confusion will be measured using 9 items which will be coded on a scale from 1 to 5 where 5 represents greater confusion endorsement.", "SecondaryOutcomeTimeFrame":"Baseline up to 24 months post intervention initiation" },{ "SecondaryOutcomeMeasure":"Patients' shared decision-making experience", "SecondaryOutcomeDescription":"Patients will answer multiple questions relating to their experience with the implementation of shared decision-making and their interactions with clinical staff. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.", "SecondaryOutcomeTimeFrame":"Baseline up to 12 months post intervention initiation" },{ "SecondaryOutcomeMeasure":"Providers'/staff shared decision-making experience", "SecondaryOutcomeDescription":"Providers and staff will answer multiple questions relating to their experience with the implementation of shared decision-making with their patients in clinical practice. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.", "SecondaryOutcomeTimeFrame":"Baseline up to 24 months post intervention initiation" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n50 to 75 years of age\nLives in or receives care in the selected intervention or comparison (control) communities\nAverage-risk for colorectal cancer\nNon-adherent to CRCS recommendation\nEnglish-speaking\nPeople who consent to participate\n\nExclusion Criteria:\n\n<50 years of age or >75 years of age\nNot living in or receiving care in the selected intervention or comparison communities\nHigh-risk for colorectal cancer\nAdherent to CRCS recommendation\nNon-English speaking\nPeople who do not consent to participate", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"50 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Resa M Jones, MPH, PhD", "OverallOfficialAffiliation":"Virginia Commonwealth University and Temple University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Allina Health Systems - Commons", "LocationCity":"Minneapolis", "LocationState":"Minnesota", "LocationZip":"55404", "LocationCountry":"United States" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000015179", "ConditionMeshTerm":"Colorectal Neoplasms" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007414", "ConditionAncestorTerm":"Intestinal Neoplasms" },{ "ConditionAncestorId":"D000005770", "ConditionAncestorTerm":"Gastrointestinal Neoplasms" },{ "ConditionAncestorId":"D000004067", "ConditionAncestorTerm":"Digestive System Neoplasms" },{ "ConditionAncestorId":"D000009371", "ConditionAncestorTerm":"Neoplasms by Site" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000003108", "ConditionAncestorTerm":"Colonic Diseases" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" },{ "ConditionAncestorId":"D000012002", "ConditionAncestorTerm":"Rectal Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16473", "ConditionBrowseLeafName":"Colorectal Neoplasms", "ConditionBrowseLeafAsFound":"Colorectal Cancer", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9031", "ConditionBrowseLeafName":"Intestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7469", "ConditionBrowseLeafName":"Gastrointestinal Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5839", "ConditionBrowseLeafName":"Digestive System Neoplasms", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4919", "ConditionBrowseLeafName":"Colonic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13427", "ConditionBrowseLeafName":"Rectal Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }