Dataset Information

Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.

ABSTRACT: BACKGROUND:Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomize hospitalized smokers to receive usual smoking cessation care alone or usual smoking care augmented with financial incentives. We aim to compare the impact of these two strategies on 1) smoking abstinence, 2) use of counseling and nicotine replacement therapy, and 3) quality of life of participants. We also will evaluate the short-term and long-term return on the investment of incentives. The FIESTA Oral Microbiome Substudy will compare the oral microbiome of smokers and nonsmokers to longitudinally assess whether smoking cessation changes oral microbiome composition. METHODS:We will enroll 182 inpatient participants from the Manhattan campus of the Veterans Affairs New York Harbor Healthcare System. All participants receive enhanced usual care, including screening for tobacco use, counseling while hospitalized, access to nicotine replacement therapy, and referral to a state Quitline. Patients in the financial incentive arm receive enhanced usual care and up to $550 for participating in the New York Smoker's Quitline, using nicotine replacement therapy (NRT), and achieving biochemically confirmed smoking cessation at 2 months and 6 months. In the microbiome substudy, we enroll nonsmoking control participants matched to each recruited smoker's hospital ward, sex, age, diabetes status, and antibiotic use. After discharge, participants are asked to complete periodic phone interviews at 2 weeks, 2 months, 6 months, and 12 months and provide expired carbon monoxide and saliva samples at 2 months, 6 months, and 12 months for cotinine testing and oral microbiome analysis. DISCUSSION:The incentive interventions of FIESTA may benefit hospitalized smokers, an objective made all the more critical because smoking rates among hospitalized patients are higher than those in the general population. Moreover, the focus of FIESTA on evidence-based therapy and bioconfirmed smoking cessation can help guide policy efforts to reduce smoking-related healthcare costs in populations with high rates of tobacco use and costly illnesses. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02506829 . Registered on 1 July 2014.

SUBMITTER: French KM

PROVIDER: S-EPMC6249787 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.

French Katherine M KM Gonzalez Sasha Z SZ Sherman Scott E SE Link Alissa R AR Malik Sadozai Zoe SZ Tseng Chi-Hong CH Jumkhawala Saahil A SA Tejada Briesny B White Andrew A Ladapo Joseph A JA

Trials 20181121 1

<h4>Background</h4>Smoking is the leading preventable cause of death in the United States, but evidence-based smoking cessation therapy is underutilized. Financial incentive strategies represent an innovative approach for increasing the use of counseling and pharmacotherapy. If effective, they could supplement or supplant resource-intensive policy options, particularly in populations for whom smoking has substantial societal costs. FIESTA (Financial IncEntives for Smoking TreAtment) will randomi ...[more]

PMID: 30463608

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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:BackgroundFinancial incentives are an effective way of helping women to stop smoking during pregnancy. Unfortunately, most women who stop smoking at this time return to smoking within 12 months of the infant's birth. There is no evidence for interventions that are effective at preventing postpartum smoking relapse. Financial incentives provided after the birth may help women to sustain cessation. This randomised controlled trial will assess the effectiveness and cost-effectiveness of financial incentives to help women who are abstinent from smoking at end-of-pregnancy to avoid return to smoking up to 12 months postpartum.MethodsThis is a UK-based, multi-centre, three-arm, superiority, parallel group, individually randomised controlled trial, with 1:1:1 allocation. It will compare the effectiveness of two financial incentive interventions with each other (one intervention for up to 3 months postpartum offering up to £120 of incentives (£60 for the participant and £60 for a significant other support); the other for up to 12 months postpartum with up to £300 of incentives (£240 for the participant and £60 for a significant other support) and with a no incentives/usual care control group. Eligible women will be between 34 weeks gestation and 2 weeks postpartum, abstinent from smoking for at least 4 weeks, have an expired carbon monoxide (CO) reading < 4 parts per million (ppm), aged at least 16 years, intend remaining abstinent from smoking after the birth and able to speak and read English. The primary outcome is self-reported, lapse-free, smoking abstinence from the last quit attempt in pregnancy until 12 months postpartum, biochemically validated by expired CO and/or salivary cotinine or anabasine. Outcomes will be analysed by intention-to-treat and regression models used to compare the proportion of abstinent women between the two intervention groups and between each intervention group and the control group. An economic evaluation will assess the cost-effectiveness of offering incentives and a qualitative process evaluation will examine barriers and facilitators to trial retention, effectiveness and implementation.DiscussionThis pragmatic randomised controlled trial will test whether offering financial incentives is effective and cost-effective for helping women to avoid smoking relapse during the 12 months after the birth of their baby.Trial registrationInternational Standard Randomised Controlled Trial Number 55218215 . Registered retrospectively on 5th June 2019.

Project description:Introduction:Three-quarters of homeless people smoke cigarettes. Financial incentives for smoking abstinence have appeared promising in nonexperimental studies of homeless smokers, but randomized controlled trial (RCT) data are lacking. Methods:We conducted a pilot RCT of financial incentives for homeless smokers. Incentive arm participants (N = 25) could earn escalating $15-$35 rewards for brief smoking abstinence (exhaled carbon monoxide <8 parts per million) assessed 14 times over 8 weeks. Control arm participants (N = 25) were given $10 at each assessment regardless of abstinence. All participants were offered nicotine patches and counseling. The primary outcome was a repeated measure of brief smoking abstinence across 14 assessments. The secondary outcome was brief abstinence at 8 weeks. Exploratory outcomes were self-reported 1-day and 7-day abstinence from (1) any cigarette and (2) any puff of a cigarette. Other outcomes included 24-hour quit attempts, nicotine patch use, counseling attendance, and changes in alcohol and drug use. Results:Compared to control, incentive arm participants were more likely to achieve brief abstinence overall (odds ratio 7.28, 95% confidence interval 2.89 to 18.3) and at 8 weeks (48% vs. 8%, p = .004). Similar effects were seen for 1-day abstinence, but 7-day puff abstinence was negligible in both arms. Incentive arm participants made more quit attempts (p = .03). Nicotine patch use and counseling attendance were not significantly different between the groups. Alcohol and drug use did not change significantly in either group. Conclusions:Among homeless smokers, financial incentives increased brief smoking abstinence and quit attempts without worsening substance use. This approach merits further development focused on promoting sustained abstinence. Registration:ClinicalTrials.gov (NCT02565381). Implications:Smoking is common among homeless people, and conventional tobacco treatment strategies have yielded modest results in this population. This pilot RCT suggests that financial incentives may be a safe way to promote brief smoking abstinence and quit attempts in this vulnerable group of smokers. However, further development is necessary to translate this approach into real-world settings and to promote sustained periods of smoking abstinence.

Project description:Prior studies by our group demonstrated the efficacy of a brief but intensive behavioral intervention for producing initial smoking abstinence among opioid-dependent patients. In the present study, our aim was to promote longer-duration abstinence in this population. Following an initial 2-week incentive intervention for smoking abstinence, we examined whether a 10-week maintenance arm involving continuation of contingent reinforcement will produce greater smoking abstinence than a similar duration of noncontingent reinforcement.Randomized, 12-week, parallel-group study.Out-patient research clinic in Burlington, Vermont, USA.Opioid-maintained smokers (n = 88) who provided breath carbon monoxide and urinary cotinine specimens and received contingent reinforcement for smoking abstinence during weeks 1-2 (phase 1), with 63 randomized on day 14 to an extended contingent (EC; n = 31) or extended noncontingent (EN; n = 32) experimental condition for weeks 3-12 (phase 2).The EC condition consisted of voucher values that escalated across consecutive negative samples until they reached $30, after which they remained at $30 per negative sample. A positive or a missing sample resulted in no vouchers for that day and reset the value of the next negative same to $9. Two consecutive negatives returned the schedule to the pre-reset value. The EN control condition consisted of vouchers delivered for providing scheduled samples, but independent of smoking status.The primary outcome was percentage of biochemically abstinent samples during phase 2. Secondary measures included abstinence status at final study visit, complete abstinence, participants' longest duration of continuous abstinence, cotinine and carbon monoxide (CO) levels and self-reported cigarettes per day.EC participants achieved greater smoking abstinence during phase 2 than EN participants [46.7 versus 23.5% negative samples, respectively; odds ratio (OR) = 2.98, 95% confidence interval (CI) = 1.16-7.65, ?(2) 1 (=) 5.0, P = 0.02]. When longest duration of continuous abstinence was compared between experimental groups, EC participants achieved twice the mean duration of continuous abstinence compared with EN participants (3.31 versus 1.68 weeks; t61 = 1.83, P = 0.07). An effect of experimental condition was also seen on mean cotinine levels (42.5 versus 210.6 ng/ml, respectively; F1,61 =5.9, P = 0.02).Among opioid-maintained smokers receiving an initial period of daily contingent incentives, a contingent reinforcement intervention appears to be more effective at extending smoking abstinence than noncontingent reinforcement over 10 weeks.

Project description:IntroductionSmoking is harmful to human health and programmes to help people stop smoking are key public health efforts that improve individual and population health outcomes. Research shows that financial incentives improve the success of stop smoking programmes. However, a better understanding of how they work is needed to better inform policy and to support building capability for implementation.The aims of this study: (1) To review the international literature to understand: How, why, in what circumstances and for whom financial incentives improve the success of stop smoking interventions among general population groups and among pregnant women. (2) To provide recommendations for how to best use financial incentives in efforts to promote smoking cessation.Methods and analysisA realist review of published international literature will be undertaken to understand how, why, for whom and in which circumstances financial incentives contribute to success in stopping smoking for general population groups and among pregnant women. Systematic searches were undertaken on 16 February 2022 of five academic databases: MEDLINE (ovid), Embase.com, CIHAHL, Scopus and PsycINFO. Iterative searching using citation tracking and of grey literature will be undertaken as needed. Using Pawson and Tilley's iterative realist review approach, data collected will be screened, selected, coded, analysed and synthesised into a set of explanatory theoretical findings.Ethics and disseminationEthical approval is not required for this review as data sources to be included are previously published. The study will provide important findings for policy-makers and health system leaders to guide the development of stop smoking services which use incentives, for example, as part of the Health Service Executive's Tobacco Free Programme in Ireland. Understanding how contextual factors impact implementation and programmatic success is key to developing a more effective public health approach to stop smoking. Our dissemination strategy will be developed with our stakeholders.Prospero registration numberCRD42022298941.

Dataset Information

Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.

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Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy.

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