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Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial.

ABSTRACT: INTRODUCTION:Evidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers. METHODS AND ANALYSIS:This ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow-ups at 1, 2, 3 and 6 months after randomisation. We aim to enrol 1134 daily smokers from 70 community sites (clusters) in Hong Kong. All participants receive Ask, Warn, Advise, Refer, Do-it-again (AWARD) guided advice and a self-help booklet at baseline. Additionally, participants in the intervention group receive an offer of referral to smoking cessation services at baseline and a small financial incentive (HK$300?US$38) contingent on using any of such services within 3 months. The primary outcomes are bioverified abstinence (exhaled carbon monoxide <4 ppm and salivary cotinine <10?ng/mL) at 3 and 6 months. Secondary outcomes include self-reported 7-day point prevalence of abstinence, smoking reduction rate, quit attempts and the use of smoking cessation services at 3 and 6 months. Intention-to-treat approach and regression models will be used in primary analyses. ETHICS AND DISSEMINATION:This protocol has been approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (IRB reference number: UW 18-318). The results of this trial will be submitted for publication in peer-reviewed journals, and the key findings will be presented at national and international conferences. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov Registry NCT03565796.

SUBMITTER: Weng X

PROVIDER: S-EPMC7592296 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial.

Weng Xue X Wang Man Ping MP Li Ho Cheung William HCW Cheung Yee Tak Derek YTD Lau Ching Yin CY Kwong Antonio Cho Shing ACS Lai Vienna Wai Yin VWY Chan Sophia Siu Chee SSC Lam Tai Hing TH

BMJ open 20201026 10

<h4>Introduction</h4>Evidence-based smoking cessation treatments are effective but underutilised, accentuating the need for novel approaches to increase use. This trial investigates the effects of active referral combined with a financial incentive to use smoking cessation services on smoking abstinence among community smokers.<h4>Methods and analysis</h4>This ongoing study is a two-arm, assessor-blinded, pragmatic, cluster randomised controlled trial with follow-ups at 1, 2, 3 and 6 months afte ...[more]

PMID: 33109654

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Project description:BackgroundFinancial incentives promote many health behaviors, but effective ways to deliver health incentives remain uncertain.MethodsWe randomly assigned CVS Caremark employees and their relatives and friends to one of four incentive programs or to usual care for smoking cessation. Two of the incentive programs targeted individuals, and two targeted groups of six participants. One of the individual-oriented programs and one of the group-oriented programs entailed rewards of approximately $800 for smoking cessation; the others entailed refundable deposits of $150 plus $650 in reward payments for successful participants. Usual care included informational resources and free smoking-cessation aids.ResultsOverall, 2538 participants were enrolled. Of those assigned to reward-based programs, 90.0% accepted the assignment, as compared with 13.7% of those assigned to deposit-based programs (P<0.001). In intention-to-treat analyses, rates of sustained abstinence from smoking through 6 months were higher with each of the four incentive programs (range, 9.4 to 16.0%) than with usual care (6.0%) (P<0.05 for all comparisons); the superiority of reward-based programs was sustained through 12 months. Group-oriented and individual-oriented programs were associated with similar 6-month abstinence rates (13.7% and 12.1%, respectively; P=0.29). Reward-based programs were associated with higher abstinence rates than deposit-based programs (15.7% vs. 10.2%, P<0.001). However, in instrumental-variable analyses that accounted for differential acceptance, the rate of abstinence at 6 months was 13.2 percentage points (95% confidence interval, 3.1 to 22.8) higher in the deposit-based programs than in the reward-based programs among the estimated 13.7% of the participants who would accept participation in either type of program.ConclusionsReward-based programs were much more commonly accepted than deposit-based programs, leading to higher rates of sustained abstinence from smoking. Group-oriented incentive programs were no more effective than individual-oriented programs. (Funded by the National Institutes of Health and CVS Caremark; ClinicalTrials.gov number, NCT01526265.).

Project description:IntroductionFinancial incentive programs promote smoking cessation. However, the incentive amount which should be provided-and how this may interact with other program characteristics-is unknown. The objective of this study was to evaluate the influence of the design of incentive programs for smoking cessation on current smokers' perceptions of programs and willingness to enroll.MethodAn online discrete choice experiment was conducted amongst adult current smokers residing in the United Kingdom (N = 430). Hypothetical incentive programs were described using five attributes (incentive amount, incentive type, frequency of sessions, reward schedules, program location). Participants responded to a series of choice sets comprised of two hypothetical programs. For each set, participants selected their preferred program. They then specified whether they would enroll in their preferred program if it were available. Analyses also considered the effect of participant income on preferences.ResultsOverall, participants preferred higher amounts over lower amounts, cash over vouchers, healthcare settings over workplaces, and consistent amounts over an escalating schedule. One session per week was the most preferred session frequency. Willingness to enroll increased quadratically with the incentive amount, although this increase slowed for higher amounts. Although middle- and high-income smokers preferred slightly higher amounts (cf. low-income participants), enrollment choices did not differ by income.ConclusionThe characteristics of incentive programs influence smokers' perceptions of programs and willingness to enroll. Higher amounts may encourage greater enrollment rates, but there will likely be a ceiling point beyond which increasing the incentive amount does not meaningfully increase enrollments.ImplicationsThere is increasing evidence incentive programs aid smoking cessation. Yet, the variety in previous program designs means how to best structure programs, including optimal incentive amount and the impact of the design on potential enrollment rates, remains unclear. This study suggests enrollments may be highest when incentive amounts are higher, rewards of a consistent amount in cash are provided, and sessions occur once per week in a healthcare setting. Although higher-income participants may desire higher incentive amounts compared to lower-income participants, this may not translate into differences in willingness to enroll.

Project description:ObjectiveTo compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country.DesignParallel group, open label, assessor blinded, cluster randomized controlled trial.SettingLarge industrial workplaces in metropolitan Bangkok, Thailand.ParticipantsEmployees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies).InterventionsWorksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40).Main outcome measuresThe primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers.ResultsBetween April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval -2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; -3.2 points, -6.6 to -0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other.ConclusionsAcceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings.Trial registrationClinicalTrials.gov (NCT02421224).

Project description:ObjectiveTo evaluate the efficacy of financial incentives dependent on continuous smoking abstinence on smoking cessation and birth outcomes among pregnant smokers.DesignSingle blind, randomised controlled trial.SettingFinancial Incentive for Smoking Cessation in Pregnancy (FISCP) trial in 18 maternity wards in France.Participants460 pregnant smokers aged at least 18 years who smoked ≤5 cigarettes/day or ≤3 roll-your-own cigarettes/day and had a pregnancy gestation of <18 weeks were randomised to a financial incentives group (n=231) or a control group (n=229).InterventionsParticipants in the financial incentives group received a voucher equivalent to €20 (£17; $23), and further progressively increasing vouchers at each study visit if they remained abstinent. Participants in the control group received no financial incentive for abstinence. All participants received a €20 show-up fee at each of six visits.Main outcome measuresThe main outcome measure was continuous smoking abstinence from the first post-quit date visit to visit 6, before delivery. Secondary outcomes in the mothers were point prevalence abstinence, time to smoking relapse, withdrawal symptoms, blood pressure, and alcohol and cannabis use in past 30 days. Secondary outcomes in the babies were gestational age at birth, birth characteristics (birth weight, length, head circumference, Apgar score), and a poor neonatal outcome-a composite measure of transfer to the neonatal unit, congenital malformation, convulsions, or perinatal death.ResultsMean age was 29 years. In the financial incentives and control groups, respectively, 137 (59%) and 148 (65%) were employed, 163 (71%) and 171 (75%) were in a relationship, and 41 (18%) and 31 (13%) were married. The participants had smoked a median of 60 cigarettes in the past seven days. The continuous abstinence rate was significantly higher in the financial incentives group (16%, 38/231) than control group (7%, 17/229): odds ratio 2.45 (95% confidence interval 1.34 to 4.49), P=0.004). The point prevalence abstinence rate was higher (4.61, 1.41 to 15.01, P=0.011), the median time to relapse was longer (visit 5 (interquartile range 3-6) and visit 4 (3-6), P<0.001)), and craving for tobacco was lower (β=-1.81, 95% confidence interval -3.55 to -0.08, P=0.04) in the financial incentives group than control group. Financial incentives were associated with a 7% reduction in the risk of a poor neonatal outcome: 4 babies (2%) in the financial incentives group and 18 babies (9%) in the control group: mean difference 14 (95% confidence interval 5 to 23), P=0.003. Post hoc analyses suggested that more babies in the financial incentives group had birth weights ≥2500 g than in the control group: unadjusted odds ratio 1.95 (95% confidence interval 0.99 to 3.85), P=0.055; sex adjusted odds ratio 2.05 (1.03 to 4.10), P=0.041; and sex and prematurity adjusted odds ratio 2.06 (0.90 to 4.71), P=0.086. As these are post hoc analyses, the results should be interpreted with caution.ConclusionsFinancial incentives to reward smoking abstinence compared with no financial incentives were associated with an increased abstinence rate in pregnant smokers. Financial incentives dependent on smoking abstinence could be implemented as a safe and effective intervention to help pregnant smokers quit smoking.Trial registrationClinicalTrials.gov NCT02606227.

Project description:IntroductionPoor retention in clinical trials can impact on statistical power, reliability, validity and generalisability of findings and is a particular challenge in smoking cessation studies. In online trials with automated follow up mechanisms, poor response also increases resource-need for manual follow up. This study compared two financial incentives on response rates at 6 months follow up, in an online, automated smoking cessation feasibility trial of a cessation smartphone app (Quit Sense).MethodsA study within a trial (SWAT), embedded within a host randomised controlled trial. Host trial participants were randomised 1:1 to receive either a £10 or £20 voucher incentive, for completing the 6-month questionnaire. Stratification for randomisation to the SWAT was by minimisation to ensure an even split of host trial arm participants, and by 6-week response rate. Outcome measures were: questionnaire completion rate, time to completion, number of completers requiring manual follow up and completeness of responses.Results204 participants were randomised to the SWAT. The £20 and £10 incentives did not differ in completion rate at 6 months (79% versus 74%; p=0.362) but did reduce the proportion of participants requiring manual follow up (46% versus 62%; p=0.018) and the median completion time (7 days versus 15 days; p=0.008). Measure response completeness rates were higher among £20 incentive participants, though differences were small for the host trial's primary smoking outcome.ConclusionsBenefits to using relatively modest increases in incentive for online smoking cessation trials include more rapid completion of follow up questionnaires and reduced manual follow up.ImplicationsA modest increase in incentive (from £10 to £20) to promote the completion of follow up questionnaires in online smoking cessation trials may not increase overall response rates but could lead to more rapid data collection, a reduced need for manual follow-up and reduced missing data among those who initiate completing a questionnaire. Such an improvement may help to reduce bias, increase validity and generalisability, and improve statistical power in smoking cessation trials.

Project description:Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group).The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates) and patient participation (proportion referred who go to the website). We will then compare the effectiveness of the standard and augmented patient websites.Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login) and patient outcomes (six-month smoking cessation).Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628.

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Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial.

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Effects of active referral combined with a small financial incentive on smoking cessation: study protocol for a cluster randomised controlled trial.

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