Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-25 @ 8:48 PM
Study NCT ID:
NCT02713594
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2016-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sss@ctri.wisc.edu', 'phone': '6082627563', 'title': 'Stevens S. Smith, Ph.D.', 'organization': 'University of Wisconsin School of Medicine and Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Adverse event data were not collected as per study protocol; no study medications were part of the protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'Counseling from WTQL', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Incentive', 'description': 'Counseling from WTQL; Financial incentive to participate', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Abstinence From Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '948', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Counseling from WTQL'}, {'id': 'OG001', 'title': 'Incentive', 'description': 'Counseling from WTQL; Financial incentive to participate'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.86', 'ciLowerLimit': '-11.28', 'ciUpperLimit': '-4.5', 'statisticalMethod': 'Abstinence Risk Difference', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured 6 months after enrollment at follow-up assessment', 'description': 'The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engagement in Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '948', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'Counseling from WTQL'}, {'id': 'OG001', 'title': 'Incentive', 'description': 'Counseling from WTQL; Financial incentive to participate'}], 'classes': [{'categories': [{'title': 'Zero Calls Taken', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '1 Call Taken', 'measurements': [{'value': '245', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}, {'title': '2 Calls Taken', 'measurements': [{'value': '179', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}, {'title': '3 Calls Taken', 'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}, {'title': '4 Calls Taken', 'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}]}, {'title': '5 Calls Taken', 'measurements': [{'value': '203', 'groupId': 'OG000'}, {'value': '435', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Chi-square test value = 196.1, with 5 degrees of freedom.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured 6 months after enrollment at follow-up assessment', 'description': 'This analysis will compare number of calls completed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cost-effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'OG000'}, {'value': '948', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': "Counseling from WTQL\n\nCounseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."}, {'id': 'OG001', 'title': 'Incentive', 'description': "Counseling from WTQL; Financial incentive to participate\n\nCounseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.\n\nFinancial incentive to participate: Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.)"}], 'classes': [{'categories': [{'measurements': [{'value': '5193', 'groupId': 'OG000'}, {'value': '4108', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured 6 months after enrollment', 'description': 'This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.', 'unitOfMeasure': 'U.S. Dollars', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': "Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."}, {'id': 'FG001', 'title': 'Incentive', 'description': "Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.\n\nParticipants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '952'}, {'groupId': 'FG001', 'numSubjects': '948'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '562'}, {'groupId': 'FG001', 'numSubjects': '552'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}, {'groupId': 'FG001', 'numSubjects': '396'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '358'}, {'groupId': 'FG001', 'numSubjects': '374'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '952', 'groupId': 'BG000'}, {'value': '948', 'groupId': 'BG001'}, {'value': '1900', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control', 'description': 'Counseling from WTQL'}, {'id': 'BG001', 'title': 'Incentive', 'description': 'Counseling from WTQL; Financial incentive to participate'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '45.0', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '45.0', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '577', 'groupId': 'BG000'}, {'value': '569', 'groupId': 'BG001'}, {'value': '1146', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '379', 'groupId': 'BG001'}, {'value': '754', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '390', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '783', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '487', 'groupId': 'BG000'}, {'value': '485', 'groupId': 'BG001'}, {'value': '972', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'American Indian/Alaska Native', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Refused/Do not know/Not collected', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '952', 'groupId': 'BG000'}, {'value': '948', 'groupId': 'BG001'}, {'value': '1900', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Count of Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1900}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-18', 'studyFirstSubmitDate': '2016-02-16', 'resultsFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-18', 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abstinence From Smoking', 'timeFrame': 'Measured 6 months after enrollment at follow-up assessment', 'description': 'The primary outcome data will be the biochemically confirmed abstinence using urine (measured cotinine) or exhaled (breath) carbon monoxide (CO).'}], 'secondaryOutcomes': [{'measure': 'Engagement in Treatment', 'timeFrame': 'Measured 6 months after enrollment at follow-up assessment', 'description': 'This analysis will compare number of calls completed'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Measured 6 months after enrollment', 'description': 'This analysis will quantify the costs of treatment for Control and Incentive conditions with regard to attaining 6-month abstinence. Project costs were allocated to three categories: 1) Service costs, including billed staff time for counseling and testing, as well as all incidentals connected with services; 2) Incentives and distribution costs; and 3) Service-related administrative costs, including promotion/marketing and staff time for administering the intervention. Costs of planning the project, grant administration, and research within the project are not included in the analysis.The outcome is the cost per quit in each treatment group. Cost per quit in each group was calculated by: 1) computing the grand total of costs for all participants in a given group; and 2) dividing the grand total for a given group by the number of successful quitters. As such, the cost per quit is a single value with no measure of dispersion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoking', 'Smoking Cessation', 'Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '29079405', 'type': 'DERIVED', 'citation': 'Fraser DL, Fiore MC, Kobinsky K, Adsit R, Smith SS, Johnson ML, Baker TB. A Randomized Trial of Incentives for Smoking Treatment in Medicaid Members. Am J Prev Med. 2017 Dec;53(6):754-763. doi: 10.1016/j.amepre.2017.08.027. Epub 2017 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to BadgerCare Plus (Medicaid) smokers as part of their health care.', 'detailedDescription': 'Previous research on providing incentives for healthy behaviors has shown that financial incentives can increase treatment participation and boost outcomes when they are tied to participation in evidence based treatments. However, most of this research has been done in laboratory settings and in relatively small clinical trials. This study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to Wisconsin BadgerCare Plus (Medicaid) smokers as part of their health care. If successful, this treatment approach could be used more broadly to reduce the considerable financial and personal costs associated with smoking-related disease.\n\nIn this study, Medicaid-eligible smokers were recruited from primary care clinics and from callers to the Wisconsin Tobacco Quit Line (WTQL) with randomization a Control condition and an Incentive condition. All participants were offered five cessation calls from the WTQL and participants were encouraged by WTQL coaches to obtain cessation medication from their primary care providers. All participants received payment for completing a baseline assessment ($40) and a 6-month smoking test ($40). Only Incentive condition participants received additional compensation for taking counseling calls ($30 per completed call) and for biochemically-verified abstinence at the 6-month visit ($40).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* enrollment in Wisconsin Medicaid (BadgerCare Plus)\n* resides in study area (one of 25 counties)\n* 18 or older\n* English or Spanish speaking\n* has smoked daily (at least 5 cigarettes each day) over the last week\n* willingness to attend visits at his/her PCC (primary care clinic) or go to a testing site at baseline and 6 months (2 times over a 6 month period), provide urine samples or participate in exhaled carbon monoxide testing, and complete follow-up phone calls from the WTQL\n* willingness to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.\n\nExclusion Criteria:\n\n* not enrolled in Wisconsin Medicaid (BadgerCare Plus)\n* not reside in study area\n* less than 18 years of age\n* not English or Spanish speaking\n* does not smoke daily (at least 5 cigarettes each day) over the last week\n* not willing to attend visits at his/her PCC (primary care clinic) or alternative testing site at baseline and 6 months (2 times over a 6 month period), provide urine or exhaled carbon monoxide samples, and complete follow-up phone calls.\n* not willing to inform the WTQL as to any change in address, phone number, clinic attended, or health plan.'}, 'identificationModule': {'nctId': 'NCT02713594', 'briefTitle': 'Wisconsin Tobacco Quit Line Medicaid Incentive Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Wisconsin Tobacco Quit Line Centers for Medicaid Services Striving To Quit Evaluation Project', 'orgStudyIdInfo': {'id': '2013-0056 (400025710)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Counseling from WTQL', 'interventionNames': ['Behavioral: Counseling from WTQL']}, {'type': 'EXPERIMENTAL', 'label': 'Incentive', 'description': 'Counseling from WTQL; Financial incentive to participate', 'interventionNames': ['Behavioral: Counseling from WTQL', 'Other: Financial incentive to participate']}], 'interventions': [{'name': 'Counseling from WTQL', 'type': 'BEHAVIORAL', 'description': "Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.", 'armGroupLabels': ['Control', 'Incentive']}, {'name': 'Financial incentive to participate', 'type': 'OTHER', 'description': 'Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.) Compensation was in the form of prepaid Visa gift cards mailed approximately 2-4 weeks after the point of contact.', 'armGroupLabels': ['Incentive']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Timothy b Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin--CTRI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}