Effectiveness and economic evaluation of self-help educational materials for the prevention of smoking relapse: randomised controlled trial

Abstract

BackgroundMost people who quit smoking successfully for a short period will return to smoking again in 12 months. A previous exploratory meta-analysis indicated that self-help booklets may be effective for smoking relapse prevention in unaided quitters.ObjectivesThis study aimed to evaluate the effectiveness of a set of self-help educational booklets to prevent smoking relapse in people who had stopped smoking with the aid of behavioural support.DesignThis is an open, randomised controlled trial and qualitative process evaluation. Trial participants were randomly allocated to one of two groups, using a simple randomisation process without attempts to stratify by participant characteristics. The participant allocation was ‘concealed’ because the recruitment of quitters occurred before the random allocation.SettingShort-term quitters were recruited from NHS Stop Smoking Clinics, and self-help educational materials were posted to study participants at home.ParticipantsA total of 1407 carbon monoxide (CO)-validated quitters at 4 weeks after quit date in NHS Stop Smoking Clinics. The trial excluded pregnant women and quitters who were not able to read the educational materials in English.InterventionsParticipants in the experimental group (n = 703) received a set of eight revisedForever Freebooklets, and participants in the control group (n = 704) received a single leaflet that is currently given to NHS patients.Main outcome measuresFollow-up telephone interviews were conducted 3 and 12 months after quit date. The primary outcome was prolonged, CO-verified abstinence from months 4 to 12 during which time no more than five cigarettes were smoked. The secondary outcomes included self-reported abstinence during the previous 7 days at 3 and 12 months, CO-verified abstinence at 12 months, costs (NHS and NHS and participant medication costs perspectives) and quality-adjusted life-years. Logistic regression analyses were conducted to investigate effect-modifying variables. A simultaneous qualitative process evaluation was conducted to help interpret the trial results.ResultsData from 1404 participants were used for the final analysis, after excluding three participants who died before the 12-month follow-up. The proportion with prolonged abstinence from months 4 to 12 after quit date was 36.9% in the intervention group and 38.6% in the control group. There was no statistically significant difference between the groups (odds ratio 0.93, 95% confidence interval 0.75 to 1.15;p = 0.509). There were no statistically significant differences between the groups in secondary smoking outcomes. People who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. However, there were no differences between the groups in the proportion of participants who reported that they knew any more about coping skills, and no differences in reported use of strategies to cope with urges to smoke between the trial groups. The qualitative study found that some quitters considered self-help booklets unhelpful for smoking relapse prevention, although positive feedback by participants was common.ConclusionsAmong quitters who had stopped smoking with the aid of intensive behavioural support, there was no significant difference in the likelihood of smoking relapse between those who subsequently received a set of eight revisedForever Freebooklets and those who received a single leaflet. Although many people had suboptimal strategies to prevent relapse and most relapsed, theForever Freebooklets proved an ineffective medium for teaching them the skills to prevent relapse. Further research should focus on interventions that may increase the use of coping skills when required.Trial registrationCurrent Controlled Trials ISRCTN36980856.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 59. See the NIHR Journals Library website for further project information.

Impact of the NHS Stop Smoking Services on smoking prevalence in England: a simulation modelling evaluation

“…The number of quit attempts supported by SSS and short-term quitters at 4 weeks after the quit date were based on SSS Statistics 20. The risk of smoking relapse by 12 months among short-term quitters was estimated according to data from three long-term follow-up studies,10 11 21 and data from the Smoking Toolkit Study 22. To be consistent with the self-reported smoking and cessation status in national surveys in England,18 we used self-reported quit rates in the present study.…”

Differences in Longer-Term Smoking Abstinence After Treatment by Specialist or Nonspecialist Advisors: Secondary Analysis of Data From a Relapse Prevention Trial

“…Study participants were those included in a randomized controlled trial of self-help material for smoking relapse prevention. 9 The target population for this trial was people who had stopped smoking, as verified by carbon monoxide (CO) reading, at 4 weeks after the quit date, following the provision of cessation support from NHS stop smoking services. The biochemically verified 4-week quitter is defined as a treated smoker who reports abstinence from at least day 14 after the quit date to the 4-week follow-up point and who blows an exhaled CO reading of less than 10 ppm.…”

“…It was found that there was no difference between the intervention groups in prolonged smoking abstinence from month 4 to 12 (37% vs. 39%, P = .51), and main findings of the trial will be published elsewhere. 9 In the trial, we also collected data on the type of stop smoking services (specialist services, or from general practice nurses, pharmacists, or community health trainers). In a secondary analysis, we examined whether there was a difference in longer-term smoking abstinence at 12 months between quitters who received smoking cessation treatment in different settings.…”

Manutenção da abstinência do tabaco por ex-fumantes: estudo fenomenológico

“…Studies have shown that, on average, smokers make three to five attempts before quitting smoking, while relapse is a frequent problem (3)(4) . Most people succeed in quitting smoking in the short term; however, relapse over a period of 12 months is quite common (5) . To maintain tobacco withdrawal in the long term requires changes in lifestyle and a high level of motivation.…”