Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial

Cheung, Yee Tak Derek; Leung, Jessica Pui Kei; Cheung, Chelsia Ka Ching; Wang, Man Ping; Lam, Tai Hing

doi:10.1186/s13063-016-1485-z

Cited by 5 publications

(5 citation statements)

References 34 publications

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“…Two cut-points were used for cotinine verification of self-report: 10ng/ml, a widely adopted threshold for active smoking in recent smoking cessation clinical trials [22-24] and the higher cut-point of 15ng/ml recommended by the SRNT Subcommittee on Biochemical Verification [10]. Although lower cut-points have been recommended based on population data [25], we retained higher cut-points because ex-smokers may be exposed to more environmental tobacco smoke than nonsmokers in the general population [26].…”

Section: Methodsmentioning

confidence: 99%

Accuracy of self‐reported smoking abstinence in clinical trials of hospital‐initiated smoking interventions

et al. 2017

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Aims To estimate the prevalence and predictors of failure biochemically to verify self-reported abstinence among participants enrolled in trials of hospital-initiated smoking cessation interventions. Design Comparison of characteristics between participants who verified and those who failed to verify self-reported abstinence. Settings Multi-site randomized clinical trials conducted between 2010 and 2014 in hospitals across the United States. Participants Recently hospitalized smokers who reported tobacco abstinence 6 months post-randomization and provided a saliva sample for verification purposes (n=822). Measurements Outcomes were salivary cotinine-verified smoking abstinence at 10ng/ml and 15ng/ml cut points. Predictors and correlates included participant demographics and tobacco use; hospital diagnoses and treatment; and study characteristics collected via surveys and electronic medical records. Findings Usable samples were returned by 69.8% of the 1,178 trial participants who reported 7-day point prevalence abstinence. The proportion of participants verified as quit was 57.8% (95% CI 54.4, 60.4; 10 ng/ml cut-off) or 60.6% (95% CI 57.2, 63.9; 15ng/ml). Factors independently associated with verification at 10ng/ml were education beyond high school education (OR=1.51; 95% CI 1.07, 2.11), continuous abstinence since hospitalization (OR=2.82; 95% CI 2.02, 3.94), mailed vs. in-person sample (OR=3.20; 95% CI 1.96, 5.21), and race. African American participants were less likely to verify abstinence than White participants (OR= 0.64; 95% CI 0.44, 0.93). Findings were similar for verification at 15ng/ml. Verification rates did not differ by treatment group. Conclusions In the USA, high rates (40%) of hospitalized smokers enrolled in smoking cessation trials fail biochemical verification of their self-reported abstinence.

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Section: Methodsmentioning

confidence: 99%

Accuracy of self‐reported smoking abstinence in clinical trials of hospital‐initiated smoking interventions

et al. 2017

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“…The NRT sampling was integrated with the TAB game experience, and our goal was that the TAB components would increase the use of NRT sampling and support long-term cessation. However, NRT sampling was not considered a component of the TAB game for the purposes of the trial because effectiveness evidence is already available for NRT sampling alone …”

Section: Methodsmentioning

confidence: 99%

“…However, NRT sampling was not considered a component of the TAB game for the purposes of the trial because effectiveness evidence is already available for NRT sampling alone. 1,3,4 The Comparison Condition To isolate the TAB game experience, we opted for an active NRT sampling comparison. We provided NRT to the comparison group.…”

Section: Key Pointsmentioning

confidence: 99%

“…Recent programs have reported that engaging people who smoke in brief, low-intensity, noncessation experiences (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) may lead to later abstinence. 1,3,4 A practice quit attempt uses brief abstinence to practice cessationsupporting behaviors, such as managing cravings using distraction and relaxation techniques. 3 Furthermore, precessation NRT sampling trials have reported improvements in self-efficacy.…”

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confidence: 99%

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Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit

et al. 2022

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IMPORTANCE Most trials of behavioral or pharmaceutical interventions for people who smoke are limited to individuals reporting they are ready to quit smoking. Engaging individuals who initially report they are not yet ready to quit in brief, precessation, skills-building interventions (eg, practice quit attempts or nicotine replacement therapy [NRT] sampling) is challenging.OBJECTIVE To test an integrated behavioral plus NRT-sampling intervention using a gamification approach supported by mobile health. DESIGN, SETTING, AND PARTICIPANTSA multisite randomized clinical trial with site-level 1-to-1 allocation into 2 conditions was conducted in 4 US health care systems. A total of 433 individuals who were currently smoking and reported at enrollment that they were not ready to quit smoking were enrolled. The study was conducted from November 7, 2016, to July 31, 2020.INTERVENTIONS Take a Break (TAB) was a 3-week game experience and included 5 behavioral components (motivational messaging, challenge quizzes, brief abstinence goal setting, mobile health apps for cravings management, and reward points for participation) integrated with NRT sampling. TAB draws on social cognitive theory and game mechanics concepts to engage participants in health behavior change. The comparison included NRT sampling only.MAIN OUTCOMES AND MEASURES Time to first quit attempt (duration from TAB experience to primary outcome) and carbon monoxide level-verified smoking cessation at 6-month follow-up. All analyses used an intention-to-treat approach. RESULTSOf the 433 individuals included in the trial, 223 were women (52%); mean (SD) age was 54 (13) years. More than half (53% [112 of 213]) of the TAB participants completed 100% of the daily challenge quizzes in the first week, 73% (145 of 199) of participants who completed the goal-setting call set a brief abstinence goal (most frequently 1-2 days of abstinence from cigarettes), and 75% (159 of 213) of participants used the mobile health apps to manage nicotine cravings. Time to the first quit attempt was lower for the TAB vs comparison group (hazard ratio, 1.68; 95% CI, 1.09-2.60; P = .02). At the 6-month follow-up, 18% (28 of 160) of TAB participants and 10% (17 of 171) of the comparison (χ 2 test, P = .045) participants obtained carbon monoxide level-verified smoking cessation (accounting for clustering of outcomes by site; odds ratio, 1.92; 95% CI, 1.01-3.68; P = .048). CONCLUSIONS AND RELEVANCE The findings of this randomized clinical trial demonstrate thatindividuals not yet ready to quit smoking could be engaged in a brief abstinence game. Six months later, the TAB group had nearly double the rate of smoking cessation vs the NRT sampling comparison group. Integrating a skills-building game experience with brief NRT sampling can enhance long-term cessation among those not yet ready to quit smoking.

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“…In addition, the nurse will deliver medication advice which addresses five main components: (1) the benefits for using NRT in quitting, (2) withdrawal symptoms due to smoking cessation, (3) side effects of NRT, (4) instructions for using NRT and (5) making appointments for smoking cessation clinics of TWGHs, which was adopted from the counselling protocol of our previous study (table 1). 23 An instruction card of using NRT will be given. Participants will be advised to either stop or reduce smoking when using the NRT.…”

Section: Interventionmentioning

confidence: 99%

Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial

Cheung

Chan

et al. 2020

BMJ Open

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IntroductionMore than half of the smoking population in Hong Kong are unmotivated to quit. Only about 2% of tobacco users in the territory have ever used cessation aids such as nicotine replacement therapy (NRT). The present study aims to assess the effectiveness of delivering 1-week free NRT sample plus brief intervention to smokers at outdoor smoking hotspots on quit attempts and use of smoking cessation services.Methods and analysisThis is a two-arm, pragmatic, multisite, cluster randomised controlled trial (RCT) on the effectiveness of increasing quit attempts, use of cessation service and recruitment outcomes. Trained smoking cessation ambassadors will approach smokers at outdoor smoking hotspots, and deliver brief smoking cessation advice. Recruitment sessions are randomised to intervention or control group (allocation ratio 1:1). Participants in the intervention group (n=550) will receive 1-week free NRT sample (either patch or gum), brief medication advice from an onsite nurse and cessation service referral, whereas participants in control group (n=275) will only receive the brief advice and service referral. The primary outcomes are the proportion of participants who enrol in any cessation service in Hong Kong within 1 month of the recruitment, and the proportion of participants who report quit attempts at 1-month follow-up. Secondary outcomes include self-reported use of NRT, self-reported 7-day tobacco abstinence, 30-day abstinence at 3 months and 6 months, biochemically validated abstinence at 6 months, perceived importance, difficulty and confidence to quit (scale 0–10), and Incremental Behavior Change towards Smoking Cessation. Process outcomes include number of smokers who will be approached, will accept the brief smoking cessation advice or be recruited to participate in the RCT.Ethics and disseminationThe Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster approved the trial (UW 18-118). Findings will be disseminated through funding website, publication and conference presentations.Trial registration numberNCT03717051

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Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial

Cited by 5 publications

References 34 publications

Accuracy of self‐reported smoking abstinence in clinical trials of hospital‐initiated smoking interventions

Accuracy of self‐reported smoking abstinence in clinical trials of hospital‐initiated smoking interventions

Effect of Technology-Assisted Brief Abstinence Game on Long-term Smoking Cessation in Individuals Not Yet Ready to Quit

Effectiveness of nicotine replacement therapy sample at outdoor smoking hotspots for initiating quit attempts and use of smoking cessation services: a protocol for a cluster randomised controlled trial

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