{"protocolSection":{"identificationModule":{"nctId":"NCT05277207","orgStudyIdInfo":{"id":"CDX 22-005"},"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Tobacco Cessation Treatment Preferences Among Veteran Smokers","officialTitle":"Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)","acronym":"MESH"},"statusModule":{"statusVerifiedDate":"2024-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2022-05-02","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-09-27","type":"ACTUAL"},"completionDateStruct":{"date":"2023-09-27","type":"ACTUAL"},"studyFirstSubmitDate":"2022-03-02","studyFirstSubmitQcDate":"2022-03-10","studyFirstPostDateStruct":{"date":"2022-03-14","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-04-10","resultsFirstSubmitQcDate":"2024-04-10","resultsFirstPostDateStruct":{"date":"2024-05-07","type":"ACTUAL"},"lastUpdateSubmitDate":"2024-04-10","lastUpdatePostDateStruct":{"date":"2024-05-07","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.","detailedDescription":"There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers in general cite several prominent barriers to delivering evidence-based tobacco cessation care, including insufficient time, lack of training, a perception of low motivation in their patients, and concerns about the sensitivity of tobacco cessation discussions. In addition, a large proportion of patients who begin tobacco cessation treatment do not achieve initial abstinence. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to personalize treatment has the potential to increase patient engagement and proactively address treatment non-response. The proposed randomized controlled trial is a two-arm experimental design to demonstrate the feasibility of a larger trial and the acceptability of the intervention design. Participants (N = 30) will be stratified by clinic and randomized to either 1) the active treatment, which includes personalized cognitive behavioral treatment, personalized smoking cessation pharmacotherapy, and test messaging support; or 2) standard of care Department of Veterans Affairs' Quitline (telehealth intervention including 5 sessions of CBT) plus SmokefreeVET (text-messaging intervention)."},"conditionsModule":{"conditions":["Tobacco Use"],"keywords":["tobacco use","smoking"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"MESH","type":"EXPERIMENTAL","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.","interventionNames":["Behavioral: Personalized Smoking Cessation Facilitation Meetings","Drug: Personalized Smoking Cessation Pharmacotherapy","Behavioral: Personalized Text Messaging Support"]},{"label":"Best Practice Telehealth Group","type":"ACTIVE_COMPARATOR","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.","interventionNames":["Behavioral: SmokefreeVET","Behavioral: VA Quitline","Other: Education about pharmacotherapy"]}],"interventions":[{"type":"BEHAVIORAL","name":"Personalized Smoking Cessation Facilitation Meetings","description":"Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.","armGroupLabels":["MESH"]},{"type":"DRUG","name":"Personalized Smoking Cessation Pharmacotherapy","description":"Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.","armGroupLabels":["MESH"]},{"type":"BEHAVIORAL","name":"Personalized Text Messaging Support","description":"If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.","armGroupLabels":["MESH"],"otherNames":["Annie"]},{"type":"BEHAVIORAL","name":"SmokefreeVET","description":"Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.","armGroupLabels":["Best Practice Telehealth Group"]},{"type":"BEHAVIORAL","name":"VA Quitline","description":"Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.","armGroupLabels":["Best Practice Telehealth Group"]},{"type":"OTHER","name":"Education about pharmacotherapy","description":"Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.","armGroupLabels":["Best Practice Telehealth Group"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants Who Report Post-treatment Satisfaction","description":"Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.","timeFrame":"Post-treatment 3-month follow-up visit (approximately three months after enrollment)"}],"secondaryOutcomes":[{"measure":"Treatment Attendance","description":"Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).","timeFrame":"Post-treatment, approximately eight weeks after baseline visit"},{"measure":"Therapist-rated Treatment Acceptability in Active Treatment Group","description":"The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.","timeFrame":"Post-treatment 3-month follow-up visit (approximately three months after enrollment)"},{"measure":"Proportion of Participants Who Completed Treatment in the Active Treatment Group","description":"The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.","timeFrame":"Post-treatment, approximately eight weeks after baseline visit"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Durham VA patient\n* willing to complete study procedures\n* appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months\n* currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week\n\nExclusion Criteria:\n\n* participation in Aim 3 (already received the intervention)\n* current hospitalization (recent hospitalization is acceptable)\n* currently not using combustible or smokeless tobacco (vaping only)\n* acute risk for suicide documented in the medical record\n* or inability to complete study procedures","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Sarah M. Wilson, PhD","affiliation":"Durham VA Medical Center, Durham, NC","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Durham VA Medical Center, Durham, NC","city":"Durham","state":"North Carolina","zip":"27705-3875","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"ipdSharingStatementModule":{"ipdSharing":"NO","description":"De-identified data sets will be available upon written FOIA request. Final data sets will also be maintained locally until enterprise-level resources become available for broader long-term storage and access unless the relevant ORD or VA Program Office Funding Announcement states otherwise."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"FG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"BG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.8","spread":"11.6"},{"groupId":"BG001","value":"61.7","spread":"10.2"},{"groupId":"BG002","value":"59.75","spread":"10.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"28"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"29"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"19"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants Who Report Post-treatment Satisfaction","description":"Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.","populationDescription":"One control participant withdrew prior to the 3-month-follow-up, resulting in 14 control group participants.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment 3-month follow-up visit (approximately three months after enrollment)","groups":[{"id":"OG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"OG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"10"}]}]}]},{"type":"SECONDARY","title":"Treatment Attendance","description":"Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment, approximately eight weeks after baseline visit","groups":[{"id":"OG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"OG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"3"}]}]}]},{"type":"SECONDARY","title":"Therapist-rated Treatment Acceptability in Active Treatment Group","description":"The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.","populationDescription":"Therapist-rated treatment acceptability was only measured in the active treatment group.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Post-treatment 3-month follow-up visit (approximately three months after enrollment)","groups":[{"id":"OG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"OG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"}]}]}]},{"type":"SECONDARY","title":"Proportion of Participants Who Completed Treatment in the Active Treatment Group","description":"The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.","populationDescription":"This outcome was only measured in active treatment recipients","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percent pts completing treatment","timeFrame":"Post-treatment, approximately eight weeks after baseline visit","groups":[{"id":"OG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability."},{"id":"OG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"0"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"100"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"6 months","eventGroups":[{"id":"EG000","title":"MESH","description":"Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.\n\nPersonalized Smoking Cessation Facilitation Meetings: Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.\n\nPersonalized Smoking Cessation Pharmacotherapy: Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.\n\nPersonalized Text Messaging Support: If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":3,"otherNumAtRisk":15},{"id":"EG001","title":"Best Practice Telehealth Group","description":"Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.\n\nSmokefreeVET: Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.\n\nVA Quitline: Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.\n\nEducation about pharmacotherapy: Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.","deathsNumAffected":0,"deathsNumAtRisk":15,"seriousNumAffected":0,"seriousNumAtRisk":15,"otherNumAffected":0,"otherNumAtRisk":15}],"otherEvents":[{"term":"Nausea due to nicotine replacement therapy","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":15}]},{"term":"mood symptoms related to Varenicline use","organSystem":"Psychiatric disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":15},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":15}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Angela Kirby","organization":"Durham VA Health Care System","email":"angela.kirby@va.gov","phone":"919-824-7729"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2022-07-25","uploadDate":"2024-04-10T14:07","filename":"Prot_SAP_001.pdf","size":525180},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2022-05-27","uploadDate":"2023-08-03T11:02","filename":"ICF_000.pdf","size":222396}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D064424","term":"Tobacco Use"},{"id":"D012907","term":"Smoking"}],"ancestors":[{"id":"D001519","term":"Behavior"}]}},"hasResults":true}