{"protocolSection":{"identificationModule":{"nctId":"NCT00440115","orgStudyIdInfo":{"id":"5R01CA101963","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01CA101963"},"secondaryIdInfos":[{"id":"5R01CA101963","type":"NIH","link":"https://reporter.nih.gov/quickSearch/5R01CA101963"}],"organization":{"fullName":"University of Kansas Medical Center","class":"OTHER"},"briefTitle":"Disease Management for Smoking Cessation","officialTitle":"Disease Management for Smokers in Rural Primary Care"},"statusModule":{"statusVerifiedDate":"2017-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2009-06"},"primaryCompletionDateStruct":{"date":"2010-12","type":"ACTUAL"},"completionDateStruct":{"date":"2010-12","type":"ACTUAL"},"studyFirstSubmitDate":"2007-02-23","studyFirstSubmitQcDate":"2007-02-23","studyFirstPostDateStruct":{"date":"2007-02-26","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-03-23","resultsFirstSubmitQcDate":"2017-05-08","resultsFirstPostDateStruct":{"date":"2017-06-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-05-08","lastUpdatePostDateStruct":{"date":"2017-06-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Kansas Medical Center","class":"OTHER"},"collaborators":[{"name":"National Cancer Institute (NCI)","class":"NIH"},{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.","detailedDescription":"The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for nicotine dependence. In this study, we will recruit 750 smokers from 20 rural, primary care clinics in Kansas. Subjects will be randomly assigned to one of three study arms, each providing 20 months of treatment: C (comparison group), LDM (low-intensity disease management) or HDM (high-intensity disease management). Participants in group C will receive health educational mailings and an offer for free nicotine replacement therapy (six weeks) or bupropion (seven weeks) every 6 months (months 0, 6, 12, and 18). Participants in LDM will receive the same interventions as C plus a low-intensity disease management program that includes a single telephone counseling session using motivational interviewing (MI) at months 0, 6, 12, and 18 to encourage a cessation attempt and also includes coordination of smoking assessments and pharmacotherapy with the patient's physician. HDM participants will receive C plus a high intensity disease management program that includes up to six telephone-based MI counseling sessions at months 0, 6, 12, and 18 to encourage a smoking cessation attempt and to prevent relapse after a quit attempt, as well as coordination of smoking assessments, quit attempts, and pharmacotherapy with the patient's physician.\n\nThe primary outcome of the study is 7-day point prevalence abstinence from cigarettes at 2 years after enrollment. Secondary outcomes include: 1) number of quit attempts and 2) progress in stage of change. If successful, this intervention will provide a generalizable model for addressing nicotine dependence that could improve long-term management of smoking in primary care."},"conditionsModule":{"conditions":["Smoking Cessation"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":750,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"High intensity disease management","type":"EXPERIMENTAL","description":"High intensity disease management, free nicotine replacement therapy or bupropion","interventionNames":["Behavioral: High intensity disease management","Drug: Bupropion"]},{"label":"Low intensity disease management","type":"EXPERIMENTAL","description":"Low intensity disease management, free nicotine replacement therapy or bupropion","interventionNames":["Behavioral: Low intensity disease management","Drug: Bupropion"]},{"label":"Comparison group","type":"OTHER","description":"Comparison group, free nicotine replacement therapy or bupropion","interventionNames":["Behavioral: Comparison group","Drug: Bupropion"]}],"interventions":[{"type":"BEHAVIORAL","name":"High intensity disease management","description":"Health education mailings, 6 motivation interviews/counseling","armGroupLabels":["High intensity disease management"]},{"type":"BEHAVIORAL","name":"Low intensity disease management","description":"Health education mailings, one motivation interview/counseling","armGroupLabels":["Low intensity disease management"]},{"type":"BEHAVIORAL","name":"Comparison group","description":"Health education mailings","armGroupLabels":["Comparison group"]},{"type":"DRUG","name":"Bupropion","description":"Buproprion or Nicotine Replacement Therapy","armGroupLabels":["Comparison group","High intensity disease management","Low intensity disease management"],"otherNames":["Nicotine Replacement Therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"7-day Point Prevalence Abstinence From Cigarettes","description":"Self-reported 7-day point prevalence abstinence from cigarettes","timeFrame":"24 months"}],"secondaryOutcomes":[{"measure":"Number of Quit Attempts","description":"Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.","timeFrame":"6, 12, 18, 24 months"},{"measure":"Progress in Stage of Change","description":"Progress in Stages of Change at 6, 12, 18, and 24 months","timeFrame":"6, 12, 18, 24 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Over the age of 18\n* Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days\n* Speak English\n* Their regular physician is a participating physician\n* Working home telephone or cellular phone\n\nExclusion Criteria:\n\n* Women who are pregnant or planning to become pregnant in the next two years\n* Plan on moving within two years\n* Display signs of dementia or other mental disorders\n* Live with a smoker already enrolled","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Edward F. Ellerbeck, MD, MPH","affiliation":"University of Kansas Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","zip":"66160","country":"United States","geoPoint":{"lat":39.11417,"lon":-94.62746}}]},"referencesModule":{"references":[{"pmid":"21233256","type":"RESULT","citation":"Cox LS, Wick JA, Nazir N, Cupertino AP, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Predictors of early versus late smoking abstinence within a 24-month disease management program. Nicotine Tob Res. 2011 Mar;13(3):215-20. doi: 10.1093/ntr/ntq227. Epub 2011 Jan 13."},{"pmid":"19901150","type":"RESULT","citation":"Cupertino AP, Wick JA, Richter KP, Mussulman L, Nazir N, Ellerbeck EF. The impact of repeated cycles of pharmacotherapy on smoking cessation: a longitudinal cohort study. Arch Intern Med. 2009 Nov 9;169(20):1928-30. doi: 10.1001/archinternmed.2009.355."},{"pmid":"19349629","type":"RESULT","citation":"Ellerbeck EF, Mahnken JD, Cupertino AP, Cox LS, Greiner KA, Mussulman LM, Nazir N, Shireman TI, Resnicow K, Ahluwalia JS. Effect of varying levels of disease management on smoking cessation: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):437-46. doi: 10.7326/0003-4819-150-7-200904070-00003."},{"pmid":"18544464","type":"RESULT","citation":"Cox LS, Cupertino AP, Mussulman LM, Nazir N, Greiner KA, Mahnken JD, Ahluwalia JS, Ellerbeck EF. Design and baseline characteristics from the KAN-QUIT disease management intervention for rural smokers in primary care. Prev Med. 2008 Aug;47(2):200-5. doi: 10.1016/j.ypmed.2008.04.013. Epub 2008 May 3."},{"pmid":"18420774","type":"RESULT","citation":"Berg CJ, Sanderson Cox L, Mahnken JD, Greiner KA, Ellerbeck EF. Correlates of self-efficacy among rural smokers. J Health Psychol. 2008 Apr;13(3):416-21. doi: 10.1177/1359105307088144."},{"pmid":"18397444","type":"RESULT","citation":"Hutcheson TD, Greiner KA, Ellerbeck EF, Jeffries SK, Mussulman LM, Casey GN. Understanding smoking cessation in rural communities. J Rural Health. 2008 Spring;24(2):116-24. doi: 10.1111/j.1748-0361.2008.00147.x."},{"pmid":"18236294","type":"RESULT","citation":"Cupertino PA, Richter KP, Cox LS, Nazir N, Greiner AK, Ahluwalia JS, Ellerbeck EF. Smoking cessation pharmacotherapy preferences in rural primary care. Nicotine Tob Res. 2008 Feb;10(2):301-7. doi: 10.1080/14622200701825817."},{"pmid":"18065851","type":"RESULT","citation":"Cupertino AP, Mahnken JD, Richter K, Cox LS, Casey G, Resnicow K, Ellerbeck EF. Long-term engagement in smoking cessation counseling among rural smokers. J Health Care Poor Underserved. 2007 Nov;18(4 Suppl):39-51. doi: 10.1353/hpu.2007.0117."},{"pmid":"16801293","type":"RESULT","citation":"Berg CJ, Cox LS, Nazir N, Mussulman LM, Ahluwalia JS, Ellerbeck EF. Correlates of home smoking restrictions among rural smokers. Nicotine Tob Res. 2006 Jun;8(3):353-60. doi: 10.1080/14622200600670132."},{"pmid":"22770436","type":"DERIVED","citation":"Yeh HW, Ellerbeck EF, Mahnken JD. Simultaneous evaluation of abstinence and relapse using a Markov chain model in smokers enrolled in a two-year randomized trial. BMC Med Res Methodol. 2012 Jul 7;12:95. doi: 10.1186/1471-2288-12-95."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Smokers screened for eligibility (n=1827)\n\nIneligible (n=714)\n\nInvited to participate (n=1113)\n\nDeclined to participate (n=305) Unable to contact (n=58)\n\nRandomly assigned (n=750)","groups":[{"id":"FG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions"},{"id":"FG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions"},{"id":"FG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"251"},{"groupId":"FG001","numSubjects":"249"},{"groupId":"FG002","numSubjects":"250"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"244"},{"groupId":"FG001","numSubjects":"238"},{"groupId":"FG002","numSubjects":"244"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"6"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"5"}]},{"type":"Incarceration","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions"},{"id":"BG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions"},{"id":"BG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"251"},{"groupId":"BG001","value":"249"},{"groupId":"BG002","value":"250"},{"groupId":"BG003","value":"750"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.4","spread":"13.5"},{"groupId":"BG001","value":"48.2","spread":"12.4"},{"groupId":"BG002","value":"47.1","spread":"13.4"},{"groupId":"BG003","value":"47.2","spread":"13.1"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"151"},{"groupId":"BG001","value":"144"},{"groupId":"BG002","value":"144"},{"groupId":"BG003","value":"439"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"100"},{"groupId":"BG001","value":"105"},{"groupId":"BG002","value":"106"},{"groupId":"BG003","value":"311"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"12"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"249"},{"groupId":"BG001","value":"243"},{"groupId":"BG002","value":"246"},{"groupId":"BG003","value":"738"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"7"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"2"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"8"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"221"},{"groupId":"BG001","value":"225"},{"groupId":"BG002","value":"225"},{"groupId":"BG003","value":"671"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"19"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"19"},{"groupId":"BG003","value":"56"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"6"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"251"},{"groupId":"BG001","value":"249"},{"groupId":"BG002","value":"250"},{"groupId":"BG003","value":"750"}]}]}]},{"title":"Stage of change","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Precontemplation","categories":[{"measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"20"},{"groupId":"BG002","value":"22"},{"groupId":"BG003","value":"65"}]}]},{"title":"Contemplation","categories":[{"measurements":[{"groupId":"BG000","value":"146"},{"groupId":"BG001","value":"153"},{"groupId":"BG002","value":"158"},{"groupId":"BG003","value":"457"}]}]},{"title":"Preparation","categories":[{"measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"70"},{"groupId":"BG003","value":"228"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"7-day Point Prevalence Abstinence From Cigarettes","description":"Self-reported 7-day point prevalence abstinence from cigarettes","populationDescription":"We used generalized linear models for the primary endpoint (self-reported abstinence at 24 months). Missing values were imputed as smokers, deaths and incarcerations were excluded from analysis.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"24 months","groups":[{"id":"OG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions"},{"id":"OG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions"},{"id":"OG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"244"},{"groupId":"OG001","value":"238"},{"groupId":"OG002","value":"244"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"68"},{"groupId":"OG001","value":"56"},{"groupId":"OG002","value":"56"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Power calculations demonstrated that 250 participants per group would have 95% power to compare combined high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.","pValue":"0.54","statisticalMethod":"Mixed Models Analysis","paramType":"Odds Ratio (OR)","paramValue":"1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.78","ciUpperLimit":"1.61","estimateComment":"(High-intensity disease management and moderate-intensity disease management) vs pharmacotherapy management"},{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","nonInferiorityComment":"Power calculations indicated that 250 participants per group would have 80% power to compare high-intensity disease management and moderate-intensity disease management with pharmacotherapy management, on the basis of 10% (pharmacotherapy management), 15% (moderate-intensity disease management), and 25% (high-intensity disease management) self-reported quit rates.","pValue":"0.18","statisticalMethod":"Mixed Models Analysis","paramType":"Odds Ratio (OR)","paramValue":"1.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.88","ciUpperLimit":"2.02","estimateComment":"High-intensity disease management vs moderate-intensity disease management"}]},{"type":"SECONDARY","title":"Number of Quit Attempts","description":"Number of quit attempts at 6, 12, 18, and 24 months. A quit attempt is defined as use of quit-smoking pharmacotherapy (nicotine patch or bupropion) during each treatment period.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"quit attempts","timeFrame":"6, 12, 18, 24 months","groups":[{"id":"OG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions"},{"id":"OG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions"},{"id":"OG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Month 6 : Quit Attempted","categories":[{"measurements":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"142"}]}]},{"title":"Month 6 : Deceased/Incarcerated","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 6 : No Quit Attempt","categories":[{"measurements":[{"groupId":"OG000","value":"78"},{"groupId":"OG001","value":"85"},{"groupId":"OG002","value":"105"}]}]},{"title":"Month 12 : Quit Attempted","categories":[{"measurements":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"114"}]}]},{"title":"Month 12 : Deceased/Incarcerated","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 12 : No Quit Attempt","categories":[{"measurements":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"151"},{"groupId":"OG002","value":"133"}]}]},{"title":"Month 18 : Quit Attempted","categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"65"}]}]},{"title":"Month 18 : Deceased/Incarcerated","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 18 : No Quit Attempt","categories":[{"measurements":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"191"},{"groupId":"OG002","value":"182"}]}]},{"title":"Month 24 : Quit Attempted","categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"55"}]}]},{"title":"Month 24 : Deceased/Incarcerated","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"}]}]},{"title":"Month 24 : No Quit Attempt","categories":[{"measurements":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"173"},{"groupId":"OG002","value":"189"}]}]}]},{"type":"SECONDARY","title":"Progress in Stage of Change","description":"Progress in Stages of Change at 6, 12, 18, and 24 months","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6, 12, 18, 24 months","groups":[{"id":"OG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions"},{"id":"OG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions"},{"id":"OG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"251"},{"groupId":"OG001","value":"249"},{"groupId":"OG002","value":"250"}]}],"classes":[{"title":"Month 6","categories":[{"title":"Pre-contemplation","measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"15"}]},{"title":"Contemplation","measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"74"},{"groupId":"OG002","value":"89"}]},{"title":"Preparation","measurements":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"98"}]},{"title":"Quit (Action/Maintenance)","measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"28"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"25"},{"groupId":"OG002","value":"17"}]},{"title":"Deceased/Incarcerated","measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 12","categories":[{"title":"Pre-contemplation","measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"24"}]},{"title":"Contemplation","measurements":[{"groupId":"OG000","value":"70"},{"groupId":"OG001","value":"71"},{"groupId":"OG002","value":"83"}]},{"title":"Preparation","measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"57"},{"groupId":"OG002","value":"79"}]},{"title":"Quit (Action/Maintenance)","measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"50"},{"groupId":"OG002","value":"38"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"23"}]},{"title":"Deceased/Incarcerated","measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 18","categories":[{"title":"Pre-contemplation","measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"17"}]},{"title":"Contemplation","measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"81"}]},{"title":"Preparation","measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"44"},{"groupId":"OG002","value":"74"}]},{"title":"Quit (Action/Maintenance)","measurements":[{"groupId":"OG000","value":"63"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"44"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"31"}]},{"title":"Deceased/Incarcerated","measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"}]}]},{"title":"Month 24","categories":[{"title":"Pre-contemplation","measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"33"}]},{"title":"Contemplation","measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"61"},{"groupId":"OG002","value":"70"}]},{"title":"Preparation","measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"46"}]},{"title":"Quit (Action/Maintenance)","measurements":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"65"},{"groupId":"OG002","value":"66"}]},{"title":"Unknown","measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"29"}]},{"title":"Deceased/Incarcerated","measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"High-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 6 motivational interviewing/counseling sessions","deathsNumAffected":7,"deathsNumAtRisk":251,"seriousNumAffected":15,"seriousNumAtRisk":251,"otherNumAffected":63,"otherNumAtRisk":251},{"id":"EG001","title":"Moderate-intensity Disease Management","description":"Health education mailings, free nicotine replacement therapy or bupropion, 2 motivational interviewing/counseling sessions","deathsNumAffected":11,"deathsNumAtRisk":249,"seriousNumAffected":2,"seriousNumAtRisk":249,"otherNumAffected":46,"otherNumAtRisk":249},{"id":"EG002","title":"Pharmacotherapy Management (Comparison Group)","description":"Health education mailings, free nicotine replacement therapy or bupropion","deathsNumAffected":6,"deathsNumAtRisk":250,"seriousNumAffected":2,"seriousNumAtRisk":250,"otherNumAffected":19,"otherNumAtRisk":250}],"seriousEvents":[{"term":"Dystonia","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Arterial Surgery","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Atrial fibriliation","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Broken Neck","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Bronchitis/COPD Exacerbation","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Collapsed lung","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"As a result of a rodeo injury","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Congestive Heart Failure","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Depression and Suicidal Ideation","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Kidney Failure","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Removal of Lung Mass","organSystem":"Surgical and medical procedures","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Smoke Inhalation","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"As a result of occupational hazard","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Stroke","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Ulcer","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Heart Surgery","organSystem":"Cardiac disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]}],"otherEvents":[{"term":"Chest Pain","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Cold Sores","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Constipation","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Depression","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Dizziness/Light Headedness","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Elevated heart rate or blood pressure","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":251},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Flu","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Headache","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Blood Clot","organSystem":"Vascular disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Bowel Falure","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Broken Bone","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Concussion","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"As a result of a fall","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Crohn's Disease Complication","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Diabetes Complication","organSystem":"Endocrine disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Eye Injury","organSystem":"Injury, poisoning and procedural complications","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Kidney Stones","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Pneumonia","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":2,"numAffected":2,"numAtRisk":250}]},{"term":"Shingles","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Stomach Pain","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":251},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Strep Throat","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Scheduled Surgery/Medical Procedure","organSystem":"Surgical and medical procedures","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":9,"numAffected":9,"numAtRisk":251},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Irritability/Nervousness","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":249},{"groupId":"EG002","numEvents":3,"numAffected":3,"numAtRisk":250}]},{"term":"Nausea","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":251},{"groupId":"EG001","numEvents":7,"numAffected":7,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]},{"term":"Nose Bleeds","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":251},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Shakiness","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":251},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":249},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":250}]},{"term":"Skin Irritation","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":15,"numAffected":15,"numAtRisk":251},{"groupId":"EG001","numEvents":8,"numAffected":8,"numAtRisk":249},{"groupId":"EG002","numEvents":7,"numAffected":7,"numAtRisk":250}]},{"term":"Sleep Disturbance","organSystem":"Product Issues","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":251},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":249},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":250}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Edward F. Ellerbeck, MD, MPH, Chair","organization":"Department of Preventive Medicine & Public Health","email":"eellerbe@kumc.edu","phone":"913-588-2829"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D016642","term":"Bupropion"},{"id":"D000095488","term":"Nicotine Replacement Therapy"}],"ancestors":[{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D004358","term":"Drug Therapy"},{"id":"D013812","term":"Therapeutics"}]}},"hasResults":true}