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Extended interactive voice response telephony (IVR) for relapse prevention after smoking cessation using… McNaughton, Bonnie; Frohlich, Jiri; Graham, Amy; Young, Quincy-Robyn Sep 10, 2013

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RESEARCH ARTICLE Open AccessExtended interactive voice response telephony(IVR) for relapse prevention after smokingcessation using varenicline and IVR: a pilot studyBonnie McNaughton1*, Jiri Frohlich1,2, Amy Graham1 and Quincy-Robyn Young1AbstractBackground: There is a significant resumption of smoking following smoking cessation using varenicline. Bothsmoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus,the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR mayfurther improve smoking cessation rates at one and two years.Methods: 101 participants were recruited from the community via newspaper advertisement. They attended agroup counseling session and were given smoking information booklets from the Canadian Cancer Society.After 12 weeks of varenicline and 9 IVR calls, all participants who had quit smoking were randomized into 2 groupsmatched by levels of motivation and addiction as per baseline questionnaire score. The intervention groupcontinued to receive bi-weekly IVR support for weeks 13 – 52. The control group no longer received IVR. Theprimary end-point was self-reported abstinence and exhaled carbon monoxide levels of less than 10 ppm for weeks12, 52 and 2 years. Data were analyzed by Fisher’s exact test or Wilcoxon rank-sum test.Results: Of the 101 participants, 44 (43%) had stopped smoking after 12 weeks of varenicline and 9 IVR calls. Ofthese, 23 (52%) were randomized to receive IVR calls from weeks 13 to 52.At 52 weeks, 26 (59%) participants remained smoke-free. Of the 23 with IVR, 12 (52.2%) stopped smoking comparedto 14 of 21 (66.7%) without IVR. At 2 years, 40 of the 44 (90.9%) randomized participants were contacted and 24 ofthe 44 (54.5%) came in for testing. Fourteen (13% of the original cohort, 30% who were abstinent at 12 weeks and53% who were abstinent at 52 weeks) remained smoke-free. Five of the 23 (21.7%) randomized to IVR and 9 of the21 (42.9%) randomized to no IVR remained smoke-free at 2 years.Conclusions: In this pilot study of an apparently healthy population, extended IVR did not affect abstinence rates.There was no relapse prevention benefit in offering 9 months of continued IVR to subjects who had stoppedsmoking after receiving 3 months of varenicline and IVR treatment.Trial registration: ClinicalTrial.gov: NCT00832806Keywords: Smoking, Non-smoking, Risk factors, Varenicline, Interactive voice response* Correspondence: bmcnaughton@providencehealth.bc.ca1Healthy Heart Program, Providence Health Care, St. Paul’s Hospital, 1081Burrard Street, Vancouver B.C. V6Z 1Y6, CanadaFull list of author information is available at the end of the article© 2013 McNaughton et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of theCreative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use,distribution, and reproduction in any medium, provided the original work is properly cited.McNaughton et al. BMC Public Health 2013, 13:824http://www.biomedcentral.com/1471-2458/13/824BackgroundWhen administered for 12 weeks, the smoking cessationdrug varenicline has been shown to lead to continuous ab-stinence rates of about 44% during the last 4 weeks oftreatment and 22 – 23% at a one-year follow-up [1,2]. Al-though varenicline’s effect exceeded that of other drugssuch as sustained-release bupropion, the cessation ratesare still low. While medications can be effective in redu-cing withdrawal symptoms and improving treatment out-comes, a combination of pharmacotherapy and behavioralcounseling is more likely to increase abstinence rates [3].IVR systems have been applied in a variety of medicalsettings and have been used successfully to assess pa-tients at home after hospital discharge for adverse out-comes [4].Three Canadian studies have explored the potential ofIVR to follow smokers after discharge as part of acomprehensive hospital-based smoking intervention (the“Ottawa Model”), demonstrating that it is feasible to useIVR in this setting and suggesting an intervention thatincludes optional automated post-discharge follow-upmay increase smoking cessation. However, the specificcontribution of IVR to cessation rates was assessed onlyin a small pilot study limited to smokers admitted withmyocardial infarction. The study showed a benefit ofIVR that did not reach statistical significance. Also, car-diac patients have higher rates of smoking cessation afterhospital discharge than a general population [4].The automated IVR uses algorithms and computerizedspeech recognition to engage smokers on the telephone: itgathers information; provides reinforcing messages and tri-ages them to a study nurse for call-back within 2 workingdays if either the smoker or the nurse identify that help isrequired. IVR is a low cost, high-yield way of contactingsmokers when they would not ordinarily be contacted.In our study everyone received a combination of medi-cation and smoking cessation counseling (through theIVR and call-back), from a study nurse if needed. Thiscombination approach gave all participants proven treat-ment and an equal opportunity to stop smoking. We hy-pothesized that IVR telephony may decrease the relapserate after smoking cessation.MethodsEthics and study designThis investigator initiated study was sponsored by PfizerCanada, producers of varenicline. The study was scruti-nized internally at the Healthy Heart Program and alsoby scientists at Pfizer Canada and Pfizer United States ofAmerica. It was approved by the Providence Health CareEthics Committee.The study is a two-arm, randomized pilot study of2 years duration to determine the effect of 9 months ofextended IVR on the effectiveness of smoking cessationafter an initial 3 months of varenicline and IVR treat-ment. The randomized component of the study includedonly those who successfully quit smoking at 12 weeks.Varenicline has been approved by Health Canada andmarketed since 2007. The IVR system includes the op-tion of direct nurse-to-subject over the telephone coun-seling. Both the automated IVR system and the directnurse-to-subject over the telephone contact are classifiedas counseling.The IVR uses algorithms and speech recognition tocollect information from participants and monitor symp-toms. It provides encouragement and reinforcing smokingcessation messages. These regular messages may serve tofurther strengthen participants’ sense of self-efficacy inremaining smoke-free [5]. If the participant requests acall-back then a study nurse would call them and helpthem get back on track with smoking cessation.Short counseling interventions have been found to bevery effective. Callback counseling provides a flexible, cost-effective intervention for smoking cessation that can beprovided by a centralized service for a large population. Itappears to encourage a greater proportion of quit attemptsand to reduce the rate of relapse among those quitting [6].Study population101 participants were recruited from the community inresponse to an advertisement in a local newspaper. Nonehad a history of cardiac or other chronic disease.Inclusion criteria: smoking 35 or more cigarettes perweek or 5 or more cigarettes per day for at least 2 yearswith no period of abstinence longer than 3 months.Exclusion criteria: use of any smoking cessation drugsor nicotine replacement drugs in the last 3 months, use ofmedications to treat depression or any psychiatric illness,history of depression or an unstable medical condition.Exclusion criteria were identified by self-report. Thestudy investigators met with each participant to completea checklist of inclusion and exclusion criteria as approvedby the hospital ethics committee. None of the participantswho attended the initial study information session had achronic disease. Those who had experienced depressionor had a mental health condition in the past year wereexcluded because of the varenicline warning label for agi-tation, hostility, depression or changes in behaviour orthinking. We excluded people who had experienced thesesymptoms in the past year.All potential participants attended an information ses-sion about smoking, smoking cessation, varenicline,eligibility for the study, and the relevance of the ques-tionnaire about demographics, motivation, stress, andsmoking. They were given an information packageincluding the Canadian Cancer Society booklets ForSmokers Who Don’t Want to Quit and For Smokers WhoWant to Quit.McNaughton et al. BMC Public Health 2013, 13:824 Page 2 of 8http://www.biomedcentral.com/1471-2458/13/824All participants gave written informed consent.The study was performed in the Healthy Heart Pro-gram, an outpatient clinic. The focus of the program ishelping people minimize their risk factors for coronaryartery disease.Initial varenicline and IVR treatmentParticipants received a 12-week supply of varenicline:0.5 mg to be taken on days 1–3, 0.5 mg twice a day ondays 4–7, and 1 mg twice a day until the end of week12. At the initial visit participants chose a target quitdate between 8 and 14 days after starting varenicline andgave their preferred calling time for the IVR technology.The IVR intervention consisted of 2 parts: establishingit is speaking to the study participant and the main datacollection section. As instructed at the beginning of thecall, the participant answers “yes” or “no” to all questionsexcept when asked about their level of confidence andtheir side effects. The IVR asks if they have had acigarette since their quit date, if they have smoked acigarette, even a puff, if they have used varenicline in thelast 14 days, have they experienced any side effects, howconfident they are that they will remain a non-smoker,and would they like to have a study nurse call them tohelp prevent relapse or provide advice about varenicline.Finally, there is a positive reinforcing message thankingand congratulating them followed by “remaining smoke-free is the single most important thing you can do foryour health”. The calls are 3–5 minutes long, dependingon their answers and which part of the algorithm theyare directed to. The IVR made a call on their quit day,then on day 3, 8, and 11, and every 2 weeks thereafter.After the 12th week of treatment, those who had stoppedsmoking were asked to come in for an exhaled carbonmonoxide level measurement to confirm their non-smoking status. The primary end-point was self-reportedabstinence and exhaled carbon monoxide levels of less than10 parts per million (ppm) at 12 and 52 weeks and 2 years.Intervention and control cohortsParticipants who had quit smoking at 12 weeks wererandomized into 2 groups matched by their level of mo-tivation and level of addiction as per psychometric ques-tionnaire at baseline. This was a stratified randomizationwhereby participants were categorized by motivationand addiction. The intervention group continued to re-ceive IVR calls every 2 weeks from weeks 13 – 52. Thecontrol group did not receive further IVR.At 52 weeks, all participants were asked to come in fora follow-up appointment and complete the same ques-tionnaire administered at the initial baseline visit. Weightand waist circumference were measured and in those whohad stopped smoking an exhaled carbon monoxide levelwas measured.At 2 years all participants were asked to come in for afinal visit to measure weight and waist circumference anddetermine smoking status. For those who were not smok-ing an exhaled carbon monoxide level was measured.AnalysisTo date, a single all-encompassing questionnaire to as-sess level of motivation to stop smoking has not beendeveloped. Rather, it is agreed that assessment of nico-tine dependence, stage of change, balance of pros andcons, level of temptation, confidence to stop smoking,and level of stress and mood is best used in combinationto assess motivation [7-9].Questionnaire data were collected at the initial and52 week visit. The Stage of Change algorithm was usedto determine the stage of readiness for change [10]. Prosand cons of change were assessed using the DecisionalBalance Scale [11]. This measured participants’ perceivedbenefits and drawbacks of stopping smoking. Their self-efficacy was measured on the Self-Efficacy and Tempta-tion Scale [12]. These questionnaires have been used inthe Canadian Heart and Stroke Foundation funded trial –The Multicentre Biofeedback Reactivity Trial: ModifyingCardiovascular Reactivity to Stress During the AcutePhase of Smoking Cessation [13].The Fagerstrom Tolerance Test of Nicotine Dependencewas used to determine level of dependence on nicotineand The Stop D Scale (Stress and Mood) to provide se-verity scores for each of the following areas: depression,anxiety, stress, anger, and poor social support [14,15].The answers to the questionnaire provide informationabout the phenotype – who responds to varenicline andIVR treatment and who does not.Motivation is a complex subject that involves motives,intents, values, and probability of success [16]. Motiv-ation is considered critical to changing problem behav-iours and to engaging in health-protection behaviourssuch as stopping smoking. Motivation for change typic-ally refers to both reasons for change and the strength ofthe desire or commitment to make the change [17].Age, gender, income, social support and number ofcigarettes smoked per day are among the factors thathave been shown to influence ability to stop smoking[18,19]. Table 1 summarizes selected variable frequenciesthat were included in the questionnaires. These are thevariables with the strongest trend toward significance.Statistical analysisSummary statistics were used to describe the demo-graphic characteristics of the study participants. Theunivariate relationship between the outcome and the po-tential predictors were analyzed by Fisher’s exact test orWilcoxon rank-sum test as appropriate.McNaughton et al. BMC Public Health 2013, 13:824 Page 3 of 8http://www.biomedcentral.com/1471-2458/13/824ResultsOf the 101 participants, 44 (43%) had stopped smokingafter 12 weeks of varenicline and 9 IVR calls. Of these44 subjects, 23 (52%) were randomized to receiveextended IVR calls from weeks 13 to 52 and 21 (48%)were in the control group. Table 2 provides the selectedvariable frequencies in subjects eligible for randomizationat week 12 (n = 44).Of the 44 participants who had quit smoking at12 weeks, 26 (59%) remained smoke-free at 52 weeks, 12of these had received extended IVR and 14 were in thecontrol group (12/23 (52%) vs. 14/21 (66.7%); p = 0.33).Table 3 provides the status at 52 weeks for those eligiblefor randomization at week 12 (n = 44).One participant who was not randomized stoppedsmoking after surgery for lung cancer. As a result, therewere 27 confirmed non-smokers at 52 weeks but only 26had been randomized at 12 weeks. One participant wasdiagnosed with lymphoma, randomized to receive ex-tended IVR and remained a non-smoker at 52 weeks,and one participant who failed to quit at 12 weeks, diedfrom an AIDS related illness.At 2 years, 40 (39%) of the original 101 participantswere contacted and 24 (23%) had their carbon monoxidemeasured. There were 14 (13% of the study population,30% of those abstinent at 12 weeks, 53% of those abstin-ent at 52 weeks) who were confirmed non-smokers. Ofthese, 5 (21% of those abstinent at 12 weeks) had re-ceived extended IVR. Thus, 5 of 23 (21.7%) on IVRversus 9 of 21 (42.9%) on no IVR (chi-square = 2.26, p =0.13) remained smoke-free at two years. Figure 1 displaysa summary flowchart of the study results at 12 weeks, 1and 2 years.The IVR responses did identify those who were strug-gling to stop smoking and these were the participantsthat were called back. There were no common psycho-social or demographic characteristics, as identified in thequestionnaire, that indicated who would respond to theIVR calls and who would not.For participants in the extended IVR group, week 12 –52, there was a low percentage of IVR calls completed(mean 37%, median 34%) and a lower percentage of as-sessments completed (mean 16%, median 16%). Thesewere the participants who had stopped smoking at12 weeks and were the subject of investigation.Variables predicting smoking cessationOur study participants were recruited from the commu-nity, while many studies included recently hospitalizedsubjects who may have a greater degree of motivation tostop smoking.Income over $54,000. showed a trend toward im-proved smoking cessation rates but was not statisticallysignificant.Table 4 displays a summary of the association betweenpotential predictors and smoking status at week 12.Table 5 displays a summary of these potential predictorsat week 52.Table 1 Summary of selected variable frequenciesVariable All subjects (n = 101)SexMissing 1 (.%)Male 67 (67.0%)Female 33 (33.0%)Present living statusMarried 45 (44.6%)Cohabiting 9 (8.9%)Coupled and not cohabiting 1 (1.0%)Widowed 4 (4.0%)Separated 3 (3.0%)Divorced 13 (12.9%)Single 26 (25.7%)Age at baselineMedian (IQR) 54.0 (45.0, 62.0)Mean (SD) 52.6 (11.8)Min & max (25.0, 73.0)Weight at baseline (kg)Median (IQR) 76.4 (66.6, 90.7)Mean (SD) 78.8 (16.6)Min & max (48.4, 136.0)Waist at baseline (cm)Median (IQR) 91.0 (83.0, 100.0)Mean (SD) 92.8 (13.9)Min & max (44.5, 134.0)Number of cigs. smoked per day at baselineMissing data 1Median (IQR) 18.0 (13.0, 22.0)Mean (SD) 19.2 (9.8)Min & max (6.0, 55.0)Status at week 12Still smoking 57 (56.4%)Not smoking 44 (43.6%)Status at week 52Missing data 33 (.%)Smoking 40 (58.8%)Not smoking 27 (39.7%)Died 1 (1.5%)Randomized to extended IVRNo 21 (47.7%)Yes 23 (52.3%)McNaughton et al. BMC Public Health 2013, 13:824 Page 4 of 8http://www.biomedcentral.com/1471-2458/13/824DiscussionThe study had a unique design and a long (2 year)follow-up.The major appeals of using IVR are its high level ofaccessibility, and cost-effectiveness. Telephones are sim-ple to use and familiar to people of most demographics,an advantage of IVR over some of the similar internet-based approaches that are currently being employed [5].Research has shown that levels of IVR compliancetends to be relatively high when used for symptom mon-itoring and as an adjunct to the treatment of chronicpain [5]. This may indicate that IVR technology workswell for people when they feel that it is beneficial andthey are motivated to reach an outcome such as painmanagement.Cardiac patients also have higher rates of smoking ces-sation after hospital discharge than a general population[4]. A study from The Ottawa Heart Institute identifiedalmost 1300 patients at admission and 91% received inter-vention to help them quit smoking. Six months after dis-charge 44% of cardiac patients were not smoking after10 weeks of nicotine patch therapy and 3 IVR calls [20].A study with a general population showed after12 weeks of varenicline or 10 weeks of transdermalnicotine patch, the last 4 weeks of treatment showed asignificantly greater abstinence rate with varenicline(55.9%) than transdermal nicotine patch (43.2%; OR1.70, 95% CI 1.26 to 2.28, p < 0.001). At 52 weeks thesenumbers decreased to 26.1% for varenicline and 20.3%for transdermal nicotine patch (OR 1.40, 95% CI 0.99 to1.99, p = 0.056) [21].Table 2 Subjects eligible for randomization at week 12(N = 44)Variable Control(n = 21)Extended IVR(n = 23)SexMale 14 (66.7%) 13 (56.5%)Female 7 (33.3%) 10 (43.5%)Present living statusMarried 7 (33.3%) 12 (52.2%)Cohabiting 1 (4.8%) 2 (8.7%)Coupled and not cohabiting 0 (0.0%) 1 (4.3%)Widowed 2 (9.5%) 2 (8.7%)Separated 1 (4.8%) 0 (0.0%)Divorced 3 (14.3%) 3 (13.0%)Single 7 (33.3%) 3 (13.0%)Age at baselineMedian (IQR) 57.0 (48.0, 61.0) 58.0 (50.0, 64.0)Mean (SD) 54.2 (10.0) 55.7 (10.9)Min & max (30.0, 69.0) (27.0, 73.0)Weight at baseline (kg)Median (IQR) 72.5 (64.4, 84.0) 76.4 (67.7, 98.3)Mean (SD) 74.7 (13.6) 83.3 (21.6)Min & max (55.1, 105.7) (48.4, 136.0)Waist at baseline (cm)Median (IQR) 91.0 (83.0, 98.0) 95.0 (87.0, 106.0)Mean (SD) 90.7 (11.4) 98.4 (15.4)Min & max (71.0, 117.5) (79.0, 134.0)Number of cigs. smoked per day at baselineMedian (IQR) 16.0 (10.0, 20.0) 18.0 (13.0, 22.0)Mean (SD) 17.3 (8.6) 18.5 (6.6)Min & max (6.0, 40.0) (7.0, 37.0)Table 3 Status at 52 weeks for those eligible forrandomization at week 12 (N = 44)Outcome Overall(N = 44)Control(N = 21)Extended IVR(N = 23)p-value1Status at week 52Missing 4 2 2 0.333Smoking 14 (35.0%) 5 (26.3%) 9 (42.9%)Not smoking 26 (65.0%) 14 (73.7%) 12 (57.1%)1Based on Fisher’s exact test.Abstinent at 12 weeks n = 44 Abstinent – no further IVR n = 21 Abstinent – IVR weeks 13 – 52 n = 23 Abstinent at 52 weeks n = 12/23 Abstinent at 52 weeks n = 14/21 Abstinent at 52 weeks n = 26 Abstinent at 2 years n = 14/24 Abstinent at 2 years n = 9/14 Abstinent at 2 years n = 5/10 12 weeks of Champix & IVR Participants n = 101 Figure 1 Flow chart.McNaughton et al. BMC Public Health 2013, 13:824 Page 5 of 8http://www.biomedcentral.com/1471-2458/13/824At 3 months this 55.9% quit rate with vareniclinecompares with our 43% quit rate after 3 months ofvareniclince and IVR. At 52 weeks the 26.1% quit ratecompares with 25% of our original group (n = 26 out of101). The quit rates for dual therapy varenicline and IVRwere lower at 3 months in our study than for monother-apy varenicline.While our study had a small sample size, it was inter-esting that those who were not smoking at 12 weeks andreceived extended IVR from weeks 13 – 52 had a 52.5%quit rate at 52 weeks. Those who were not smoking at12 weeks and did not receive extended IVR had a 66.7%quit rate. It would appear that if you are able to quit by12 weeks with varenicline and IVR you have a higherlikelihood of not smoking at 52 weeks than if you hadstopped with use of varenicline alone.Relapse preventionThe Cochrane Review for “relapse prevention interventionsfor smoking cessation” found that there is insufficientevidence, at the moment, to support the use of any specificbehavioural intervention for helping smokers who havesuccessfully quit for a short time to avoid relapse. The ver-dict is strongest for interventions focusing on identifyingand resolving tempting situations, as most studies wereconcerned with these. There is little research availableregarding other behavioural approaches. However, ex-tended treatment with varenicline (past 12 weeks) mayprevent relapse [22].All participants in the study consented to receivingIVR calls. As IVR and varenicline were the basis of thestudy protocol it is difficult to determine how many weremotivated to participate in IVR contact. There were nopredictors (age, gender, number of cigarettes smoked perday) at 12 and 52 weeks as to who would respond to theIVR calls. Also, for those who had quit smoking atTable 4 Association between potential predictors andsmoking status at week 12 univariate analysisVariable Smoking(n = 57)Not smoking(n = 44)p-value1Sex 0.392Missing 1 (.%) 0 (.%)Male 40 (59.7%) 27 (40.3%)Female 16 (48.5%) 17 (51.5%)Present living status 0.554Married/Cohabiting 32 (59.3%) 22 (40.7%)Single/Others2 25 (53.2%) 22 (46.8%)Age at baseline 0.104Median (IQR) 52.0 (40.0, 61.0) 57.5 (49.0, 63.0)Mean (SD) 50.8 (12.6) 55.0 (10.4)Min & max (25.0, 70.0) (27.0, 73.0)Weight at baseline (kg) 0.856Median (IQR) 77.2 (66.7, 90.7) 75.4 (64.8, 90.2)Mean (SD) 78.5 (15.0) 79.2 (18.5)Min & max (50.2, 109.5) (48.4, 136.0)Waist at baseline (cm) 0.319Median (IQR) 91.0 (82.5, 99.0) 92.3 (85.3, 101.5)Mean (SD) 91.3 (13.7) 94.7 (14.0)Min & max (44.5, 127.0) (71.0, 134.0)Number of cigs. smoked per day at baseline 0.467Median (IQR) 20.0 (14.0, 23.0) 18.0 (13.0, 20.0)Mean (SD) 20.2 (11.2) 18.0 (7.6)Min & max (6.0, 55.0) (6.0, 40.0)1Depending on the type of the variable, p-value is based on Fisher’s exact testor Wilcoxon rank-sum test.2Others include widowed, separated, divorced and coupled (not cohabiting).Table 5 Association between potential predictors andsmoking status at week 52 - for those randomizedVariable Smoking(n = 14)Not smoking(n = 26)p-value1Treatment group 0 .333Control 5 (26.3%) 14 (73.7%)Extended IVR 9 (42.9%) 12 (57.1%)Sex 0.736Male 8 (32.0%) 17 (68.0%)Female 6 (40.0%) 9 (60.0%)Present living status 0.510Married/Cohabiting 6 (28.6%) 15 (71.4%)Single/Others2 8 (42.1%) 11 (57.9%)Age at baseline 0.966Median (IQR) 57.5 (50.0, 63.0) 59.0 (48.0, 64.0)Mean (SD) 56.3 (8.5) 55.3 (11.8)Min & max (41.0, 69.0) (27.0, 73.0)Weight at baseline (kg) 0.092Median (IQR) 69.7 (64.2, 77.4) 80.9 (68.1, 91.5)Mean (SD) 72.9 (15.4) 82.4 (19.8)Min & max (55.1, 111.0) (48.4, 136.0)Waist at baseline (cm) 0.072Median (IQR) 87.8 (83.0, 95.0) 96.5 (89.0, 103.5)Mean (SD) 90.1 (13.6) 97.3 (13.9)Min & max (71.0, 125.5) (72.5, 134.0)Number of cigs. smokedper day at baseline0.493Median (IQR) 19.0 (12.0, 25.0) 17.0 (13.0, 20.0)Mean (SD) 18.9 (8.4) 16.9 (7.3)Min & max (7.0, 37.0) (6.0, 40.0)1Depending on the type of the variable, p-value is based on Fisher’s exact testor Wilcoxon rank-sum test.2Others include widowed, separated, divorced and coupled (not cohabiting).McNaughton et al. BMC Public Health 2013, 13:824 Page 6 of 8http://www.biomedcentral.com/1471-2458/13/82412 weeks and were randomized to receive 19 additionalcalls between week 12 and 52, there were no predictors.The IVR initiates contact as opposed to Quit Linesthat people call. If participants request a call back or iftheir IVR responses indicate they are struggling withremaining smoke-free, are smoking, or experiencing sideeffects, a study nurse calls them. Proactive telephonecounseling not initiated by calls to helplines helps smokersinterested in quitting (44 studies, >24,000 participants, RR1.29, 95% CI 1.20 to 1.38) [4].There is some evidence of a dose response; one or twobrief calls are less likely to provide a measurable benefit.Three or more calls increase the chances of quittingcompared to a minimal intervention such as providingstandard self-help materials, brief advice, or comparedto pharmacotherapy alone. Telephone quitlines providean important route of access to support for smokers,and call-back counseling enhances their usefulness [23].In our study, participants received 9 IVR calls in thefirst 12 weeks and those who were randomized to re-ceive extended IVR from weeks 13 – 52 received an add-itional 19 calls. We are not aware of any studies withthis many IVR calls for this long of a period.While relapse was progressive from week 13 through52, those who had quit with IVR and varenicline at12 weeks had relatively low relapse rates for smokingcessation by 52 weeks. Interestingly, those who had quitat 12 weeks (43%) and went on to receive extended IVRhad a 52.5% quit rate at 52 weeks (n = 12/23). Thosewho had quit at 12 weeks and did not receive furthercare had a 66.7% quit rate (n = 14/21).Future studies will hopefully address the possibility of aninverse benefit ratio of, for example, receiving more than 9IVR calls. To our knowledge, there have been no pub-lished trials providing IVR and telephone call-back coun-seling as an adjunct to varenicline for smoking cessation.We were not able to follow-up with study subjects tofind out why they lost interest with the IVR.The time of year chosen for follow-up may not havebeen conducive to attending follow-up appointmentsand responding to IVR calls. Follow-up appointmentswere scheduled at 12 weeks, 52 weeks and 2 years. All ofthese times coincided with summer season which mayhave been a barrier to attending. Also, the opportunity toreceive the varenicline at no charge may have attracted aselect population. The study participants were a lower in-come group ($42,000. average annual income) than theprovincial average ($67,000). Other studies have shown alink between lower average income and ability to stopsmoking [24,25].ConclusionsOur data show a lack of significant reduction in relapserates at 52 weeks in apparently healthy participants whohad received extended IVR (weeks 12 – 52) afterstopping smoking with an initial 12 week treatment ofvarenicline and IVR.Although age, treatment, baseline weight and incomeshowed trends as predictors of smoking cessation, theywere not statistically significant. These findings suggest alarger study is needed before allocating health care fundsfor IVR in a healthy population without chronic disease.Competing interestsJiri Frohlich was a member of Pfizer (Canada) Medical Advisory Board andreceived speaking honoraria. He also participated in several clinical trials andreceived grants for investigator initiated studies.Authors’ contributionsJF obtained research funding and supervised all intervention development.JF and BM participated in the conception of the study and developed itsdesign. AG and BM developed interactive voice response telephonyinterview scripts and analyzed and interpreted its data. QY providedquestionnaire development and analysis methods. BM prepared data foranalysis, including quality assurance and data consolidation. BM wrote themanuscript draft and JF revised it critically for intellectual content. All authorsread and approved the final manuscript.AcknowledgementsThis study was funded by Pfizer Canada. The authors acknowledge AndrewIgnaszewski for helping with patient recruitment, Fred Bass and Greg Bondyfor the presentation of smoking related education sessions for participants,Sarah Cockell for questionnaire interpretation, Min Li for data input, JoelSinger and Terry Lee for statistical analysis, Andrew Juren for follow-upassessment and Monica Juren for literature search.Author details1Healthy Heart Program, Providence Health Care, St. Paul’s Hospital, 1081Burrard Street, Vancouver B.C. V6Z 1Y6, Canada. 2Department of Pathologyand Laboratory Medicine, University of British Columbia, Vancouver, BC,Canada.Received: 6 May 2013 Accepted: 30 August 2013Published: 10 September 2013References1. Jorenby DE, Hays JT, Rigotti NA, et al: Efficacy of varenicline, an α4β2nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA 2006, 296:56–63.2. 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J Pers SocPsychol 1985, 48:1279–1289.12. Velicer WF, DiClemente CC, Rossi JS, Prochaska JO: Relapse situations andself-efficacy: an integrative model. Addict Behav 1990, 15:271–283.13. Nolan R, Parrot A, Irvine J, Reid G, Ramsden V, et al: The multi-centrebiofeedback reactivity trial: modifying cardiovascular reactivity to stress duringthe acute phase of smoking cessation. Schools of Psychology and GraduateStudies: University of Ottawa; 1999.14. Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO: The Fagerstromtest for nicotine dependence: a revision of the Fagerstrom tolerancequestionnaire. Br J Addict 1991, 86:1119–27.15. Young Q, Ignaszewski A, Fofonoff D, Kaan A: Stop D scale. J Cardiovasc Nurs2007, 22:525–534.16. McClelland: Human motivation. New York: Press Syndicate, University ofCambridge; 1987.17. Curry S, Wagner E: Evaluation of intrinsic motivation interventions with aself-help smoking cessation program. J Consult Clin Psychol 1991,59(2):318–323.18. Vangeli E, Stapleton J, Smit E, Borland R, West R: Predictors of attempts tostop smoking and their success in adult general population samples: asystematic review. Addiction 2011, 106(12):2110–2121.19. Winkleby M, Jatulis D, Frank E, Fortmann S: Socioeconomic status andhealth: how education, income, and occupation contribute to risk factorsfor cardiovascular disease. Am J Public Health 1992, 82(6):816–819.20. Reid R, Pipe A, Quinlan B: Promoting smoking cessation duringhospitalization for coronary artery disease. Can J Cardiol 2006, 22(9):775–780.21. Aubin H, Bobak A, Britton J, Oncken C, Billing C, Gong J, Williams K, ReevesK: Varenicline versus transdermal nicotine patch for smoking cessation:results from a randomized open-label trial. Thorax 2008, 63(8):1–18.22. Hajek P, Stead L, West R, Jarvis M, Lancaster T: Relapse preventioninterventions for smoking cessation (Cochrane Review). Cochrane Library2009, 1:2–14.23. Stead L, Perera R, Lancaster T: Telephone counseling for smokingcessation (Cochrane Review). Cochrane Library 2009, 3:2–18.24. Tobacco Control Programme of Health Canada: Physicians for a smoke-freeCanada. Ottawa: Canadian Community Health Survey, Ottawa, Cycle;2005:3–1.25. Laaksonen M, Rahkonen O, Karvonen S, et al: Socioeconomic status andsmoking. Eur J Public Health 2005, 15:262–269.doi:10.1186/1471-2458-13-824Cite this article as: McNaughton et al.: Extended interactive voiceresponse telephony (IVR) for relapse prevention after smoking cessationusing varenicline and IVR: a pilot study. BMC Public Health 2013 13:824.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitMcNaughton et al. BMC Public Health 2013, 13:824 Page 8 of 8http://www.biomedcentral.com/1471-2458/13/824

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