{"protocolSection":{"identificationModule":{"nctId":"NCT01714323","orgStudyIdInfo":{"id":"1R01HL111821","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01HL111821"},"organization":{"fullName":"Massachusetts General Hospital","class":"OTHER"},"briefTitle":"Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers","officialTitle":"Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers","acronym":"Helping HAND2"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2012-12"},"primaryCompletionDateStruct":{"date":"2016-10","type":"ACTUAL"},"completionDateStruct":{"date":"2016-10","type":"ACTUAL"},"studyFirstSubmitDate":"2012-10-22","studyFirstSubmitQcDate":"2012-10-23","studyFirstPostDateStruct":{"date":"2012-10-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-11-23","resultsFirstSubmitQcDate":"2018-05-11","resultsFirstPostDateStruct":{"date":"2018-06-08","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-05-11","lastUpdatePostDateStruct":{"date":"2018-06-08","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Nancy A. Rigotti","investigatorTitle":"Professor of Medicine","investigatorAffiliation":"Massachusetts General Hospital"},"leadSponsor":{"name":"Massachusetts General Hospital","class":"OTHER"},"collaborators":[{"name":"University of Pittsburgh","class":"OTHER"},{"name":"North Shore Medical Center","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":false,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized each year, and hospital admission offers a \"teachable moment\" for intervention. Hospital-initiated smoking cessation intervention is effective, but only if contact continues for more than 1 month after discharge. The challenge is to translate this research into clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals can adopt. The major barrier is sustaining contact after discharge. This project tests an innovative strategy to streamline the delivery and maximize the uptake of post-discharge smoking interventions.\n\nSpecific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of evidence-based tobacco treatment (counseling and medication) after hospital discharge, thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco abstinence.\n\nStudy Design: A multi-site randomized controlled comparative effectiveness trial will enroll 1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All subjects will receive a brief in-hospital smoking intervention and be randomly assigned at discharge to either Standard Care (passive referral to their state quitline) or Extended Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.\n\nOutcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month follow-up \\[primary outcome\\] and other tobacco abstinence measures); (2) treatment utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine the intervention's effect on hospital readmissions and mortality in the 6 months after discharge."},"conditionsModule":{"conditions":["Cigarette Smoking","Tobacco Smoking","Tobacco Use Disorder"],"keywords":["Cigarette smoking","Tobacco smoking","Tobacco use disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":1359,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Standard care","type":"OTHER","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.","interventionNames":["Behavioral: Standard Care"]},{"label":"Sustained Care","type":"EXPERIMENTAL","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.","interventionNames":["Behavioral: Sustained Care"]}],"interventions":[{"type":"BEHAVIORAL","name":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.","armGroupLabels":["Sustained Care"]},{"type":"BEHAVIORAL","name":"Standard Care","description":"Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.","armGroupLabels":["Standard care"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Tobacco Abstinence - 6 Month Follow-up","description":"Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up","timeFrame":"6 months"}],"secondaryOutcomes":[{"measure":"Continuous Tobacco Abstinence","description":"Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.","timeFrame":"1 month, 3 months, 6 months"},{"measure":"Point Prevalence Tobacco Abstinence","description":"7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report","timeFrame":"1 month, 3 months, 6 months"},{"measure":"Duration of Tobacco Abstinence After Hospital Discharge","description":"Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.","timeFrame":"1 month, 3 months, 6 months"},{"measure":"Use of Smoking Cessation Treatment After Hospital Discharge","description":"Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).","timeFrame":"1 month, 3 months, 6 months"}],"otherOutcomes":[{"measure":"All-cause Hospitalizations","description":"Self-reported admission to a hospital in the 12 months after the index hospitalization.","timeFrame":"12 months"},{"measure":"All-cause Mortality","description":"Death from any cause in the 6 months after hospital discharge","timeFrame":"6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission and at least 1 cigarette per day when smoking at baseline rate in the month before hospital admission)\n* Counseled by hospital smoking counselor during hospital stay\n* Plans to stop smoking tobacco products after hospital discharge\n* Agrees to take home a supply of smoking cessation medication after discharge\n* Agrees to and able to accept telephone calls after hospital discharge\n\nExclusion Criteria:\n\n* No access to a telephone or unable to communicate by telephone\n* Severe psychiatric or neurologic disease precluding ability to provide informed consent and to be counseled\n* Pregnant, nursing, or planning to become pregnant in next 3 months\n* Unable to speak English\n* Medical instability precluding study participation","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Nancy A Rigotti, MD","affiliation":"Massachusetts General Hospital","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","zip":"02114","country":"United States","geoPoint":{"lat":42.35843,"lon":-71.05977}},{"facility":"North Shore Medical Center","city":"Salem","state":"Massachusetts","zip":"01970","country":"United States","geoPoint":{"lat":42.51977,"lon":-70.89552}},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","zip":"15213","country":"United States","geoPoint":{"lat":40.44062,"lon":-79.99589}}]},"referencesModule":{"references":[{"pmid":"31687769","type":"DERIVED","citation":"Triant VA, Grossman E, Rigotti NA, Ramachandran R, Regan S, Sherman SE, Richter KP, Tindle HA, Harrington KF. Impact of Smoking Cessation Interventions Initiated During Hospitalization Among HIV-Infected Smokers. Nicotine Tob Res. 2020 Jun 12;22(7):1170-1177. doi: 10.1093/ntr/ntz168."},{"pmid":"30156578","type":"DERIVED","citation":"Streck JM, Chang Y, Tindle HA, Regan S, Park ER, Levy DE, Singer DE, Ylioja T, Rigotti NA. Smoking Cessation After Hospital Discharge: Factors Associated With Abstinence. J Hosp Med. 2018 Nov 1;13(11):774-778. doi: 10.12788/jhm.2997. Epub 2018 Aug 29."},{"pmid":"29582077","type":"DERIVED","citation":"Rigotti NA, Chang Y, Tindle HA, Kalkhoran SM, Levy DE, Regan S, Kelley JHK, Davis EM, Singer DE. Association of E-Cigarette Use With Smoking Cessation Among Smokers Who Plan to Quit After a Hospitalization: A Prospective Study. Ann Intern Med. 2018 May 1;168(9):613-620. doi: 10.7326/M17-2048. Epub 2018 Mar 27."},{"pmid":"28616847","type":"DERIVED","citation":"Rigotti NA, Chang Y, Rosenfeld LC, Japuntich SJ, Park ER, Tindle HA, Levy DE, Reid ZZ, Streck J, Gomperts T, Kelley JHK, Singer DE. Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. J Gen Intern Med. 2017 Sep;32(9):1005-1013. doi: 10.1007/s11606-017-4085-z. Epub 2017 Jun 14."},{"pmid":"27647060","type":"DERIVED","citation":"Rigotti NA, Tindle HA, Regan S, Levy DE, Chang Y, Carpenter KM, Park ER, Kelley JH, Streck JM, Reid ZZ, Ylioja T, Reyen M, Singer DE. A Post-Discharge Smoking-Cessation Intervention for Hospital Patients: Helping Hand 2 Randomized Clinical Trial. Am J Prev Med. 2016 Oct;51(4):597-608. doi: 10.1016/j.amepre.2016.04.005."},{"pmid":"25879193","type":"DERIVED","citation":"Reid ZZ, Regan S, Kelley JH, Streck JM, Ylioja T, Tindle HA, Chang Y, Levy DE, Park ER, Singer DE, Carpenter KM, Reyen M, Rigotti NA. Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers: study protocol for the Helping HAND 2 randomized controlled trial. BMC Public Health. 2015 Feb 7;15:109. doi: 10.1186/s12889-015-1484-0."}]},"ipdSharingStatementModule":{"ipdSharing":"UNDECIDED"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).","recruitmentDetails":"Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014","groups":[{"id":"FG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"FG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"677"},{"groupId":"FG001","numSubjects":"680"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"513"},{"groupId":"FG001","numSubjects":"508"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"164"},{"groupId":"FG001","numSubjects":"172"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"BG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"677"},{"groupId":"BG001","value":"680"},{"groupId":"BG002","value":"1357"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.8","spread":"12.4"},{"groupId":"BG001","value":"49.6","spread":"12.8"},{"groupId":"BG002","value":"49.7","spread":"12.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"336"},{"groupId":"BG001","value":"332"},{"groupId":"BG002","value":"668"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"341"},{"groupId":"BG001","value":"348"},{"groupId":"BG002","value":"689"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"677"},{"groupId":"BG001","value":"680"},{"groupId":"BG002","value":"1357"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Tobacco Abstinence - 6 Month Follow-up","description":"Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"113"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared","paramType":"Risk Ratio (RR)","paramValue":"1.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.84","ciUpperLimit":"1.37"}]},{"type":"SECONDARY","title":"Continuous Tobacco Abstinence","description":"Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"1 month, 3 months, 6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"title":"1 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"179"},{"groupId":"OG001","value":"211"}]}]},{"title":"3 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"122"},{"groupId":"OG001","value":"147"}]}]},{"title":"6 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"101"},{"groupId":"OG001","value":"121"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"}]},{"type":"SECONDARY","title":"Point Prevalence Tobacco Abstinence","description":"7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"1 month, 3 months, 6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"title":"1 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"217"},{"groupId":"OG001","value":"295"}]}]},{"title":"3 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"206"},{"groupId":"OG001","value":"253"}]}]},{"title":"6 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"180"},{"groupId":"OG001","value":"209"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"This compares at Month 1","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001"],"groupDescription":"This is analysis for Month 3","nonInferiorityType":"SUPERIORITY","pValue":"<0.01","statisticalMethod":"Chi-squared"},{"groupIds":["OG000","OG001"],"groupDescription":"This is for Month 6","nonInferiorityType":"SUPERIORITY","pValue":"<0.09","statisticalMethod":"Chi-squared"}]},{"type":"SECONDARY","title":"Duration of Tobacco Abstinence After Hospital Discharge","description":"Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"days","timeFrame":"1 month, 3 months, 6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"7","lowerLimit":"2","upperLimit":"75"},{"groupId":"OG001","value":"14","lowerLimit":"3","upperLimit":"90"}]}]}]},{"type":"SECONDARY","title":"Use of Smoking Cessation Treatment After Hospital Discharge","description":"Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"1 month, 3 months, 6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"title":"1 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"306"},{"groupId":"OG001","value":"491"}]}]},{"title":"3 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"404"},{"groupId":"OG001","value":"554"}]}]},{"title":"6 month follow-up","categories":[{"measurements":[{"groupId":"OG000","value":"448"},{"groupId":"OG001","value":"580"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.","statisticalMethod":"Chi-squared"}]},{"type":"OTHER_PRE_SPECIFIED","title":"All-cause Hospitalizations","description":"Self-reported admission to a hospital in the 12 months after the index hospitalization.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"hospital admissions","timeFrame":"12 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"224"},{"groupId":"OG001","value":"216"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"}]},{"type":"OTHER_PRE_SPECIFIED","title":"All-cause Mortality","description":"Death from any cause in the 6 months after hospital discharge","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"6 months","groups":[{"id":"OG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor."},{"id":"OG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"677"},{"groupId":"OG001","value":"680"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","statisticalMethod":"Chi-squared"}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"1 year (hospital readmissions); 6 months (deaths)","description":"Hospital admissions for 1 year after index hospitalization were obtained by chart review of admissions to the network of hospitals affiliated with Partners HealthCare and University of Pittsburgh Medical Center. Deaths in the first 6 months were systematically identified at patient assessments (1, 3, and 6 months). No systematic assessment of other adverse events during the trial was done due to the intervention's minimal risk.","eventGroups":[{"id":"EG000","title":"Standard Care","description":"At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.\n\nStandard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.","seriousNumAffected":224,"seriousNumAtRisk":677,"otherNumAffected":0,"otherNumAtRisk":677},{"id":"EG001","title":"Sustained Care","description":"A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.\n\nSustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free \\& Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.","seriousNumAffected":216,"seriousNumAtRisk":680,"otherNumAffected":0,"otherNumAtRisk":680}],"seriousEvents":[{"term":"Hospital Readmission","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":677},{"groupId":"EG001","numAffected":70,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":677},{"groupId":"EG001","numAffected":4,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":677},{"groupId":"EG001","numAffected":8,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":50,"numAtRisk":677},{"groupId":"EG001","numAffected":48,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":677},{"groupId":"EG001","numAffected":15,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":677},{"groupId":"EG001","numAffected":25,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Eye disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":677},{"groupId":"EG001","numAffected":1,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":677},{"groupId":"EG001","numAffected":13,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":677},{"groupId":"EG001","numAffected":7,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":677},{"groupId":"EG001","numAffected":31,"numAtRisk":680}]},{"term":"Hospital Readmisson","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":677},{"groupId":"EG001","numAffected":22,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Metabolism and nutrition disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":677},{"groupId":"EG001","numAffected":35,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Musculoskeletal and connective tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":677},{"groupId":"EG001","numAffected":8,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":677},{"groupId":"EG001","numAffected":17,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":677},{"groupId":"EG001","numAffected":19,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":677},{"groupId":"EG001","numAffected":29,"numAtRisk":680}]},{"term":"Hospital Readmission","organSystem":"Vascular disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":677},{"groupId":"EG001","numAffected":31,"numAtRisk":680}]},{"term":"Death","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":677},{"groupId":"EG001","numAffected":2,"numAtRisk":680}]},{"term":"Death","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":677},{"groupId":"EG001","numAffected":4,"numAtRisk":680}]},{"term":"Death","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":677},{"groupId":"EG001","numAffected":1,"numAtRisk":680}]},{"term":"Death","organSystem":"Hepatobiliary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":677},{"groupId":"EG001","numAffected":1,"numAtRisk":680}]},{"term":"Death","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":677},{"groupId":"EG001","numAffected":4,"numAtRisk":680}]},{"term":"Death","organSystem":"Injury, poisoning and procedural complications","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":677},{"groupId":"EG001","numAffected":1,"numAtRisk":680}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Nancy Rigotti, MD","organization":"Massachusetts General Hospital","email":"nrigotti@partners.org","phone":"617-724-4709"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000073865","term":"Cigarette Smoking"},{"id":"D000073869","term":"Tobacco Smoking"},{"id":"D014029","term":"Tobacco Use Disorder"}],"ancestors":[{"id":"D012907","term":"Smoking"},{"id":"D001519","term":"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":"D059039","term":"Standard of Care"}],"ancestors":[{"id":"D019984","term":"Quality Indicators, Health Care"},{"id":"D011787","term":"Quality of Health Care"},{"id":"D006298","term":"Health Services Administration"},{"id":"D017530","term":"Health Care Quality, Access, and Evaluation"}]}},"hasResults":true}