{"protocolSection":{"identificationModule":{"nctId":"NCT01299896","orgStudyIdInfo":{"id":"02936"},"secondaryIdInfos":[{"id":"R01CA141596","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01CA141596"}],"organization":{"fullName":"University of Pittsburgh","class":"OTHER"},"briefTitle":"Connect to Quit for Smoking","officialTitle":"Connect to Quit: Coordinated Care for Smoking Cessation Among Low Income Veterans","acronym":"CTQ"},"statusModule":{"statusVerifiedDate":"2016-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-03"},"primaryCompletionDateStruct":{"date":"2015-02","type":"ACTUAL"},"completionDateStruct":{"date":"2015-02","type":"ACTUAL"},"studyFirstSubmitDate":"2011-01-27","studyFirstSubmitQcDate":"2011-02-17","studyFirstPostDateStruct":{"date":"2011-02-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-01-21","resultsFirstSubmitQcDate":"2016-01-26","resultsFirstPostDateStruct":{"date":"2016-02-24","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-02-23","lastUpdatePostDateStruct":{"date":"2016-03-22","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Pittsburgh","class":"OTHER"},"collaborators":[{"name":"National Institutes of Health (NIH)","class":"NIH"},{"name":"National Cancer Institute (NCI)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this research study is to examine the effectiveness of an intervention designed to reduce smoking in low income veterans within a regional United States Veterans Administration(VA) health care system. A proactive, personalized, coordinated system of care \"Connect to Quit (CTQ)\" is rooted in the Chronic Care Model. CTQ treats smoking as a chronic condition, like hypertension or diabetes, that requires long term treatment with appropriate combinations of behavioral therapy and pharmacotherapy. CTQ will be evaluated in the context of three (3) VA Pittsburgh Healthcare System (VAPHS) medical practices.","detailedDescription":"Approximately 40 Primary Care Providers (PCPs), including non-physicians, in the VAPHS and their patients will be recruited and randomized to either Connect to Quit (CTQ) or Usual Care (UC), existing Veterans Health Administration (VHA) services. After PCPs are enrolled, we will begin recruiting their patients who meet eligibility criteria. The desire to quit smoking is not required for participation in the study, as the point of CTQ is to engage smokers at every level of readiness to quit. Target enrollment is 660 participants, approximately 330 in each treatment arm. Participants will be followed for a minimum of 2 years and a maximum of 4. Investigators will measure abstinence (biochemically-validated, 30 day point-prevalence) throughout the study, assessed every 6 months."},"conditionsModule":{"conditions":["Smoking","Smoking Cessation"],"keywords":["Cigarette Smoking","Smoking, Tobacco","Tobacco Smoking","Smoking Cessation","Tobacco Dependence"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":633,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Usual Care","type":"ACTIVE_COMPARATOR","description":"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.","interventionNames":["Other: Usual Care"]},{"label":"Coordinated Care","type":"ACTIVE_COMPARATOR","description":"A CTQ Coordinator will coordinate the delivery of smoking related care.","interventionNames":["Other: Coordinated Care"]}],"interventions":[{"type":"OTHER","name":"Coordinated Care","description":"CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.","armGroupLabels":["Coordinated Care"],"otherNames":["Smoking, Tobacco","Tobacco Smoking","Smoking Cessation","Tobacco, Intervention","Nicotine Replacement","Buproprion, Wellbutrin","Chantix, Varenicline","Behavorial therapy"]},{"type":"OTHER","name":"Usual Care","description":"Standard therapy to help participants with smoking cessation.","armGroupLabels":["Usual Care"],"otherNames":["Smoking, Tobacco","Tobacco Smoking","Smoking Cessation","Tobacco, Intervention","Nicotine Replacement","Buproprion, Wellbutrin","Chantix, Varenicline","Behavorial therapy"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Effectiveness of CTQ vs UC","description":"We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \\<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.","timeFrame":"Two (2) year period"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female 18 years or older\n* Veterans seen by a primary care physician within the VAPHS\n* Household income not more than $36,000 annually\n* Smoke at least 1 cigarette per day\n\nExclusion Criteria:\n\n* Smokeless tobacco (snuff or chew) users\n* Non-cigarette (e.g., pipe) smokers\n* Non-English speaking patients\n* Can not be enrolled in another smoking cessation related clinical trial at the time of enrollment","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Hilary A. Tindle, MD, MPH","affiliation":"Vanderbilt University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"VA Pittsburgh Healthcare System","city":"Pittsburgh","state":"Pennsylvania","zip":"15206","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Usual Care","description":"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.\n\nUsual Care: Standard therapy to help participants with smoking cessation."},{"id":"FG001","title":"Coordinated Care","description":"A CTQ Coordinator will coordinate the delivery of smoking related care.\n\nCoordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"319"},{"groupId":"FG001","numSubjects":"314"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"318"},{"groupId":"FG001","numSubjects":"296"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"18"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"11"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Usual Care","description":"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.\n\nUsual Care: Standard therapy to help participants with smoking cessation."},{"id":"BG001","title":"Coordinated Care","description":"A CTQ Coordinator will coordinate the delivery of smoking related care.\n\nCoordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"319"},{"groupId":"BG001","value":"314"},{"groupId":"BG002","value":"633"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54.7","spread":"11.5"},{"groupId":"BG001","value":"55.7","spread":"8.7"},{"groupId":"BG002","value":"55.2","spread":"10.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"66"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"291"},{"groupId":"BG001","value":"276"},{"groupId":"BG002","value":"567"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"319"},{"groupId":"BG001","value":"314"},{"groupId":"BG002","value":"633"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Effectiveness of CTQ vs UC","description":"We will measure abstinence of CTQ smokers vs those in Usual Care (UC). We will biochemically-validate (defined as salivary cotinine \\<10ng/ml) self reported abstinence (30 day point-prevalence) at the end of 2 years.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants per arm","timeFrame":"Two (2) year period","groups":[{"id":"OG000","title":"Usual Care","description":"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.\n\nUsual Care: Standard therapy to help participants with smoking cessation."},{"id":"OG001","title":"Coordinated Care","description":"A CTQ Coordinator will coordinate the delivery of smoking related care.\n\nCoordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"319"},{"groupId":"OG001","value":"314"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7.5"},{"groupId":"OG001","value":"6.1"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Events were collected starting at day 0 and continuing at six month intervals for a minimum of two years maximum 4 years pending date of enrollment.","description":"Hospitalization is the most common serious adverse event for our study population because hospitalization is common among smokers. Serious adverse events were obtained during follow up assessments and/or through chart extraction.","eventGroups":[{"id":"EG000","title":"Usual Care","description":"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.\n\nUsual Care: Standard therapy to help participants with smoking cessation.","seriousNumAffected":181,"seriousNumAtRisk":319,"otherNumAffected":0,"otherNumAtRisk":319},{"id":"EG001","title":"Coordinated Care","description":"A CTQ Coordinator will coordinate the delivery of smoking related care.\n\nCoordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.","seriousNumAffected":175,"seriousNumAtRisk":314,"otherNumAffected":0,"otherNumAtRisk":314}],"seriousEvents":[{"term":"Hospitalization","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":157,"numAtRisk":319},{"groupId":"EG001","numAffected":162,"numAtRisk":314}]},{"term":"Death","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":319},{"groupId":"EG001","numEvents":295,"numAffected":13,"numAtRisk":314}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Hilary A. Tindle","organization":"Vanderbilt University","email":"hilary.tindle@vanderbilt.edu","phone":"615-875-9726"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D012907","term":"Smoking"},{"id":"D016540","term":"Smoking Cessation"},{"id":"D000073865","term":"Cigarette Smoking"},{"id":"D000073869","term":"Tobacco Smoking"},{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D001519","term":"Behavior"},{"id":"D015438","term":"Health Behavior"},{"id":"D064424","term":"Tobacco Use"},{"id":"D019966","term":"Substance-Related Disorders"},{"id":"D064419","term":"Chemically-Induced Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D000074602","term":"Smoking Devices"},{"id":"D062789","term":"Tobacco Products"},{"id":"D008722","term":"Methods"},{"id":"D000095488","term":"Nicotine Replacement Therapy"},{"id":"D016642","term":"Bupropion"},{"id":"D000068580","term":"Varenicline"}],"ancestors":[{"id":"D008420","term":"Manufactured Materials"},{"id":"D013676","term":"Technology, Industry, and Agriculture"},{"id":"D008919","term":"Investigative Techniques"},{"id":"D004358","term":"Drug Therapy"},{"id":"D013812","term":"Therapeutics"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"}]}},"hasResults":true}