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A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

ABSTRACT: INTRODUCTION:Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to sudden infant death syndrome, respiratory diseases and increased likelihood of taking up smoking. These risks impact the long-term health of the child with associated increase in health costs. Emerging evidence suggests that offering financial incentives to pregnant women to quit is highly cost effective.This protocol describes the economic evaluation of a multi-centre randomised controlled trial (Cessation in Pregnancy Incentives Trial III, CPIT III) designed to establish whether offering financial incentives, in addition to usual care, is effective and cost effective in helping pregnant women to quit. METHODS AND ANALYSIS:The economic evaluation will identify, measure and value resource use and outcomes from CPIT III, comparing participants randomised to either usual care or usual care plus up to £400 financial incentives. Within-trial and long-term analyses will be conducted from a National Health Service and Personal Social Services perspective; the outcome for both analyses will be quality adjusted life-years measured using EQ-5D-5L. Patient level data collected during the trial will be used for the within-trial analysis, with an additional outcome of cotinine validated quit rates at 34-38 weeks gestation and 6?months postpartum. The long-term model will be informed by data from the trial and published literature. ETHICS AND DISSEMINATION:TRIAL REGISTRATION NUMBER: ISRCTN15236311; Pre-results (https://doi.org/10.1186/ISRCTN15236311).

SUBMITTER: McMeekin N

PROVIDER: S-EPMC7592273 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

McMeekin Nicola N Sinclair Lesley L Bauld Linda L Tappin David Michael DM Mitchell Alex A Boyd Kathleen Anne KA

BMJ open 20201027 10

<h4>Introduction</h4>Smoking results in an average 10-year loss of life, but smokers who permanently quit before age 40 can expect a near normal lifespan. Pregnancy poses a good opportunity to help women to stop; around 80% of women in the UK have a baby, most of whom are less than 40 years of age. Smoking prevalence during pregnancy is high: 17%-23% in the UK. Smoking during pregnancy causes low birth weight and increases the risk of premature birth. After birth, passive smoking is linked to su ...[more]

PMID: 33109658

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Project description:BackgroundEighty per cent of UK women have at least one baby, making pregnancy an opportunity to help women stop smoking before their health is irreparably compromised. Smoking cessation during pregnancy helps protect infants from miscarriage, still birth, low birth weight, asthma, attention deficit disorder and adult cardiovascular disease. UK national guidelines highlight lack of evidence for effectiveness of financial incentives to help pregnant smokers quit. This includes a research recommendation: within a UK context, are incentives an acceptable, effective and cost-effective way to help pregnant women who smoke to quit?MethodsThe Cessation in Pregnancy Incentives Trial (CPIT) III is a pragmatic, 42-month, multi-centre, parallel-group, individually randomised controlled superiority trial of the effect on smoking status of adding to usual Stop Smoking Services (SSS) support, the offer of up to £400 of financial voucher incentives, compared with usual support alone, to quit smoking during pregnancy. Participants (n?=?940) are pregnant smokers (age?>?16 years, <?24?weeks pregnant, English speaking), who consent via telephone to take part and are willing to be followed-up in late pregnancy and 6?months after birth. The primary outcome is cotinine/anabasine-validated abstinence from smoking in late pregnancy. Secondary outcomes include engagement with SSS, quit rates at 4 weeks from agreed quit date and 6?months after birth, and birth weight. Outcomes will be analysed by intention to treat, and regression models will be used to compare treatment effects on outcomes. A meta-analysis will include data from the feasibility study in Glasgow. An economic evaluation will assess cost-effectiveness from a UK NHS perspective. Process evaluation using a case-study approach will identify opportunities to improve recruitment and learning for future implementation. Research questions include: what is the therapeutic efficacy of incentives; are incentives cost-effective; and what are the potential facilitators and barriers to implementing incentives in different parts of the UK?DiscussionThis phase III trial in Scotland, England and Northern Ireland follows a successful phase II trial in Glasgow, UK. The participating sites have diverse SSS that represent most cessation services in the UK and serve demographically varied populations. If found to be acceptable and cost-effective, this trial could demonstrate that financial incentives are effective and transferable to most UK SSS for pregnant women.Trial registrationCurrent Controlled Trials, ISRCTN15236311. Registered on 9 October 2017.

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:IntroductionSmoking during pregnancy increases the risk of morbidity and mortality of the mother and child. The inability of the unborn child to protect itself, raises the social and academic responsibility to protect the child from the harmful effects of smoking. Interventions including rewards (incentives) for lifestyle changes are an upcoming trend and can encourage women to quit smoking. However, these incentives can, as we will argue, also have negative consequences, for example the restriction of personal autonomy and encouragement of smoking to become eligible for participation. To prevent these negative consequences, we developed an ethical framework that enables to assess and address unwanted consequences of incentive-based interventions whereby moral permissibility can be evaluated.Aims and methodsThe possible adverse consequences of incentives were identified through an extensive literature search. Subsequently, we developed ethical criteria to identify these consequences based on the biomedical ethical principles of Beauchamp and Childress.ResultsOur framework consists of 12 criteria. These criteria concern (1) effectiveness, (2) support of a healthy lifestyle, (3) motivational for the target population, (4) stimulating unhealthy behavior, (5) negative attitudes, (6) personal autonomy, (7) intrinsic motivation, (8) privacy, (9) fairness, (10) allocation of incentives, (11) cost-effectiveness, and (12) health inequity. Based on these criteria, the moral permissibility of potential interventions can be evaluated.ConclusionsIncentives for smoking cessation are a response to the responsibility to protect the unborn child. But these interventions might have possible adverse effects. This ethical framework aims to identify and address ethical pitfalls in order to avoid these adverse effects.ImplicationsAlthough various interventions to promote smoking cessation during pregnancy exist, many women still smoke during pregnancy. Interventions using incentives for smoking cessation during pregnancy are a promising and upcoming trend but can have unwanted consequences. This ethical framework helps to identify and address ethical pitfalls in order to avoid these adverse effects.It can be a practical tool in the development and evaluation of these interventions and in evaluating the moral permissibility of interventions using incentives for smoking cessation during pregnancy.

Project description:Cigarette smoking during pregnancy increases risk for pregnancy complications, growth restriction, and other adverse health outcomes. The most effective intervention for reducing smoking during pregnancy is financial incentives contingent on biochemically-verified smoking abstinence. The present study examined the efficacy of a smartphone-based intervention whereby smoking monitoring and incentive delivery occurred remotely using a mobile app. If efficacious, this remote intervention would allow pregnant women residing in geographically remote areas to benefit from incentives-based cessation interventions. Sixty U.S. pregnant smokers were recruited between May 2018 to May 2019 via obstetrical clinics, Women, Infants, and Children (WIC) offices, and Facebook. Participants were assigned sequentially to one of two treatments: best practices alone (N = 30) or best practices plus financial incentives (N = 30). Outcomes were analyzed using repeated measures analysis based on generalized estimating equations (GEE). Seven-day point prevalence abstinence rates were greater in the incentives versus best practices arms early- (46.7% vs 20.0%, OR = 3.50, 95%CI = 1.11,11.02) and late-antepartum (36.7% vs 13.3%, OR = 3.76, 95%CI = 1.04,13.65), and four- (36.7% vs 10.0%, OR = 5.21, 95%CI = 1.28,21.24) and eight-weeks postpartum (40.0% vs 6.7%, OR = 9.33, 95%CI = 1.87,46.68), although not at the 12- (23.3% vs 10.0%, OR = 2.74, 95%CI = 0.63,11.82) or 24-week (20.0% vs 6.7%, OR = 3.50, 95%CI = 0.65,18.98) postpartum assessments likely due to this pilot study being underpowered for discerning differences at the later assessments, especially 24-weeks postpartum which was three months after treatment completion. These results support the efficacy of this remote, incentives-based intervention for pregnant smokers. Further research evaluating its efficacy and cost-effectiveness in a well-powered, randomized controlled trial appears warranted.

Project description:ObjectivesFinancial incentives are recommended by the UK's National Institute for Health and Care Excellence to aid smoking cessation in pregnancy. However, little is known about how implementation contexts might impact on their effectiveness. Variations in smoking cessation support (usual care) for pregnant women who smoke were examined qualitatively as part of a prospective process evaluation of the Cessation in Pregnancy Incentives Trial (CPIT III).DesignLongitudinal case studies of five CPIT III trial sites informed by realist evaluation.SettingA stop smoking service (SSS) serving a maternity hospital constituted each case study, located in three UK countries.ParticipantsData collection included semistructured interviews with trial participants (n=22), maternity (n=12) and SSS staff (n=17); and site observations and perspectives recorded in fieldnotes (n=85).ResultsCessation support (usual care) for pregnant women varied in amount, location, staff capacity, flexibility and content across sites. SSS staff capacity was important to avoid gaps in support. Colocation and good working relationships between maternity and SSS professionals enabled prioritisation and reinforced the importance of smoking cessation. Sites with limited use of carbon monoxide (CO) monitoring reduced opportunities to identify smokers while inconsistency around automatic referral processes prevented the offer of cessation support. SSS professionals colocated within antenatal clinics were available to women they could not otherwise reach. Flexibility around location, timing and tailoring of approaches for support, facilitated initial and sustained engagement and reduced the burden on women.ConclusionsTrial sites faced varied barriers and facilitators to delivering cessation support, reflecting heterogeneity in usual care. If financial incentives are more effective with concurrent smoking cessation support, sites with fewer barriers and more facilitators regarding this support would be expected to have more promising trial outcomes. Future reporting of trial outcomes will assist in understanding incentives' generalisability across a wide range of usual care settings.Trial registration numberISRCTN15236311.

Project description:Introduction: Smoking is a major cause of disease burden and reduced quality of life for people with severe mental illness (SMI). It places significant resource pressure on health systems and financial stress on smokers with SMI (SSMI). Telephone-based smoking cessation interventions have been shown to be cost effective in general populations. However, evidence suggests that SSMI are less likely to be referred to quitlines, and little is known about the effectiveness and cost effectiveness of such interventions that specifically target SSMI. The Quitlink randomized controlled trial for accessible smoking cessation support for SSMI aims to bridge this gap. This paper describes the protocol for evaluating the cost effectiveness of Quitlink. Methods: Quitlink will be implemented in the Australian setting, utilizing the existing mental health peer workforce to link SSMI to a tailored quitline service. The effectiveness of Quitlink will be evaluated in a clustered randomized controlled trial. A cost-effectiveness evaluation will be conducted alongside the Quitlink clustered randomized controlled trial (RCT) with incremental cost-effectiveness ratios (ICERs) calculated for the cost (AUD) per successful quit and quality adjusted life year (QALY) gained at 8 months compared with usual care from both health care system and limited societal perspectives. Financial implications for study participants will also be investigated. A modeled cost-effectiveness analysis will also be conducted to estimate future costs and benefits associated with any treatment effect observed during the trial. Results will be extrapolated to estimate the cost effectiveness of rolling out Quitlink nationally. Sensitivity analyses will be undertaken to assess the impact on results from plausible variations in all modeled variables. Discussion: SSMI require additional support to quit. Quitlink utilizes existing peer worker and quitline workforces and tailors quitline support specifically to provide that increased cessation support. Given Quitlink engages these existing skilled workforces, it is hypothesized that, if found to be effective, it will also be found to be both cost effective and scalable. This protocol describes the economic evaluation of Quitlink that will assess these hypotheses. Ethics and dissemination: Full ethics clearances have been received for the methods described below from the University of Newcastle (Australia) Human Research Ethics Committee (H-2018-0192) and St Vincent's Hospital, Melbourne (HREC/18/SVHM/154). The trial has been registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12619000244101). Participant consent is sought both to participate in the study and to have the study data linked to routine health administrative data on publicly subsidized health service and pharmaceutical use, specifically the Medicare Benefits and Pharmaceutical Benefits Schemes (MBS/PBS). Trial findings (including economic evaluation) will be published in peer reviewed journals and presented at international conferences. Collected data and analyses will be made available in accordance with journal policies and study ethics approvals. Results will be presented to relevant government authorities with an interest in cost effectiveness of these types of interventions.

Dataset Information

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

Publications

A protocol for the economic evaluation of the smoking Cessation in Pregnancy Incentives Trial III (CPIT III).

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