{ "FullStudy":{ "Rank":217814, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516489", "OrgStudyIdInfo":{ "OrgStudyId":"01334" }, "Organization":{ "OrgFullName":"Corporal Michael J. Crescenz VA Medical Center", "OrgClass":"FED" }, "BriefTitle":"Improving Fecal Occult Blood Test Completion Rates Among Veterans", "OfficialTitle":"Improving Fecal Occult Blood Test Completion Rates Among Veterans" }, "StatusModule":{ "StatusVerifiedDate":"October 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 23, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 26, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Steven C. Marcus, PhD", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Corporal Michael J. Crescenz VA Medical Center" }, "LeadSponsor":{ "LeadSponsorName":"Corporal Michael J. Crescenz VA Medical Center", "LeadSponsorClass":"FED" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"VA Pittsburgh Healthcare System", "CollaboratorClass":"FED" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Colorectal Cancer" ] }, "KeywordList":{ "Keyword":[ "screening", "colon cancer", "incentives", "behavioral economics" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1", "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Prevention", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"1549", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Stage 1 Control Group", "ArmGroupType":"No Intervention", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days." },{ "ArmGroupLabel":"$5 Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 1" ] } },{ "ArmGroupLabel":"$10 Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $10 at PVAMC.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 1" ] } },{ "ArmGroupLabel":"$20 Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $20 at PVAMC.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 1" ] } },{ "ArmGroupLabel":"$5 Voucher-Based Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be mailed a voucher that can be exchanged for $5 at PVAMC.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 2" ] } },{ "ArmGroupLabel":"$50 Lottery-Based Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will have a 1 in 10 chance of being mailed a voucher that can be exchanged for $50 at PVAMC.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 2" ] } },{ "ArmGroupLabel":"$500 Raffle-Based Incentive", "ArmGroupType":"Experimental", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that states that if they complete and return their FOBT kit within 30 days, they will be entered into a raffle in which 1 randomly chosen patient (out of about 100 patients) will be mailed a check in the amount of $500.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Behavioral: Stage 2" ] } },{ "ArmGroupLabel":"Stage 2 Control Group", "ArmGroupType":"No Intervention", "ArmGroupDescription":"In the FOBT kit, individuals will receive a card that asks them to complete and return their FOBT kit within 30 days." } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Behavioral", "InterventionName":"Stage 1", "InterventionDescription":"Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "$10 Incentive", "$20 Incentive", "$5 Incentive" ] } },{ "InterventionType":"Behavioral", "InterventionName":"Stage 2", "InterventionDescription":"Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "$5 Voucher-Based Incentive", "$50 Lottery-Based Incentive", "$500 Raffle-Based Incentive" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"FOBT completion and return", "PrimaryOutcomeTimeFrame":"30 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm", "SecondaryOutcomeDescription":"There are 2 secondary outcomes. First, we will compare time to FOBT kit return by arm. Second, we will compare 30 day FOBT completion rates among previously non-adherent patients (i.e., individuals who had failed to complete a prescribed FOBT kit in the year prior to the start of the study) by arm.", "SecondaryOutcomeTimeFrame":"30 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.\n\nExclusion Criteria:\n\nNone. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.", "HealthyVolunteers":"No", "Gender":"Male", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jeffrey T Kullgren, MD, MS, MPH", "OverallOfficialAffiliation":"Corporal Michael J. Crescenz VA Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Steven C Marcus, PhD", "OverallOfficialAffiliation":"Corporal Michael J. Crescenz VA Medical Center", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Philadelphia Veterans Affairs Medical Center", "LocationCity":"Philadelphia", "LocationState":"Pennsylvania", "LocationZip":"19104", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25402401", "ReferenceType":"derived", "ReferenceCitation":"Kullgren JT, Dicks TN, Fu X, Richardson D, Tzanis GL, Tobi M, Marcus SC. Financial incentives for completion of fecal occult blood tests among veterans: a 2-stage, pragmatic, cluster, randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S35-43. doi: 10.7326/M13-3015." } ] } } }, "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" } ] } } } } } }