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Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasing success rates. iQuit has demonstrated feasibility, acceptability, and potential effectiveness. OBJECTIVE:This definitive trial aims to determine the effectiveness and cost-effectiveness of iQuit when used as an adjunct to the usual support provided to patients who wish to quit smoking, compared with usual care alone. METHODS:The iQuit in Practice II trial is a two-arm, parallel-group, randomized controlled trial (RCT) with a 1:1 individual allocation comparing usual care (ie, pharmacotherapy combined with multisession behavioral support)-the control-with usual care plus iQuit-the intervention. Participants were recruited through primary care clinics and talked to a smoking cessation advisor. Participants were randomized during the initial consultation, and those allocated to the intervention group received a tailored advice report and 90 days of text messaging in addition to the standard support provided to all patients. RESULTS:The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6 months after the quit date. A sample size of 1700 participants, with 850 per arm, would yield 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance. The Cambridge East Research Ethics Committee approved the study in February 2016, and funding for the study was granted from May 2016. In total, 1671 participants were recruited between August 2016 and July 2019. Follow-up for all participants was completed in January 2020. Data analysis will begin in the summer of 2020. CONCLUSIONS:iQuit in Practice II is a definitive, pragmatic RCT assessing whether a digital intervention can augment the impact of routine smoking cessation support in primary care. Previous research has found good acceptability and feasibility for delivering iQuit among smoking cessation advisors working in primary care. If demonstrated to be cost-effective, iQuit could be delivered across primary care and other settings, such as community pharmacies. The potential benefit would likely be highest where less behavioral support is delivered. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 44559004; http://www.isrctn.com /ISRCTN44559004. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17160.

SUBMITTER: Proctor J

PROVIDER: S-EPMC7388034 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

Proctor Joanna J Naughton Felix F Sloan Melanie M Hopewell Sarah S Hopewell Sarah S Brimicombe James J Prevost A Toby AT Wilson Edward C F ECF Coleman Tim T Sutton Stephen S

JMIR research protocols 20200714 7

<h4>Background</h4>The prevalence of smoking is declining; however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to most smokers. However, this setting has one of the lowest success rates. The iQuit in practice intervention (iQuit) is a tailored web-based and text message intervention developed for use in primary care consultations as an adjunct to routine smoking cessation support with the aim of increasi ...[more]

PMID: 32673255

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Project description:BackgroundAlthough evidence exists for the effectiveness of web-based smoking cessation interventions, information about the cost-effectiveness of these interventions is limited.ObjectiveThe study investigated the cost-effectiveness and cost-utility of two web-based computer-tailored (CT) smoking cessation interventions (video- vs. text-based CT) compared to a control condition that received general text-based advice.MethodsIn a randomized controlled trial, respondents were allocated to the video-based condition (N?=?670), the text-based condition (N?=?708) or the control condition (N?=?721). Societal costs, smoking status, and quality-adjusted life years (QALYs; EQ-5D-3L) were assessed at baseline, six-and twelve-month follow-up. The incremental costs per abstinent respondent and per QALYs gained were calculated. To account for uncertainty, bootstrapping techniques and sensitivity analyses were carried out.ResultsNo significant differences were found in the three conditions regarding demographics, baseline values of outcomes and societal costs over the three months prior to baseline. Analyses using prolonged abstinence as outcome measure indicated that from a willingness to pay of €1,500, the video-based intervention was likely to be the most cost-effective treatment, whereas from a willingness to pay of €50,400, the text-based intervention was likely to be the most cost-effective. With regard to cost-utilities, when quality of life was used as outcome measure, the control condition had the highest probability of being the most preferable treatment. Sensitivity analyses yielded comparable results.ConclusionThe video-based CT smoking cessation intervention was the most cost-effective treatment for smoking abstinence after twelve months, varying the willingness to pay per abstinent respondent from €0 up to €80,000. With regard to cost-utility, the control condition seemed to be the most preferable treatment. Probably, more time will be required to assess changes in quality of life. Future studies with longer follow-up periods are needed to investigate whether cost-utility results regarding quality of life may change in the long run.Trial registrationNederlands Trial Register NTR3102.

Project description:BackgroundSmoking in pregnancy is a major international public health problem. Self-help support (SHS) increases the likelihood of women stopping smoking in pregnancy and delivering this kind of support by text message could be a cost-effective way to deliver SHS to pregnant women who smoke. SHS delivered by text message helps non-pregnant smokers to stop but the currently available message programmes are not appropriate for use in pregnancy. A randomised controlled trial (RCT) has demonstrated the feasibility and acceptability of using a programme called 'MiQuit' to text SHS support to pregnant women who smoke. Another pilot RCT has shown that it would be feasible to run a larger, multi-centre trial within the UK National Health Service (NHS). The aim of this third RCT is to complete MiQuit's evaluation, demonstrating whether or not this is efficacious for smoking cessation in pregnancy.Methods/designThis is a multi-centre, parallel-group RCT. Pregnant women aged over 16 years, of less than 25 weeks' gestation who smoke one or more daily cigarettes but smoked at least five daily cigarettes before pregnancy and who understand written English and are being identified in 24 English antenatal care hospitals. Participants are randomised to control or intervention groups in a 1:1 ratio stratified by gestation (< 16 weeks versus ≥ 16 weeks). All participants receive a leaflet on stopping smoking during pregnancy; they are also able to access standard NHS smoking cessation support. Intervention group women also receive the 12-week MiQuit programme of tailored, interactive text message, and self-help cessation support. Women are followed up by telephone at 4 weeks after randomisation and 36 weeks' gestation. The RCT will recruit 692 women (346 per group), enabling a 95% confidence interval for the difference in quit rates to be estimated within ± 3%. To determine whether or not MiQuit helps pregnant smokers to stop, intervention group quit rates from this trial will be combined with those from the two earlier trials in a Trial Sequential Analysis (TSA) meta-analysis to derive a pooled efficacy estimate.DiscussionIf effective, MiQuit will be a cheap, cost-effective method to help pregnant women to stop smoking.Trial registrationClinicalTrials.gov, ID: NCT03231553 . Registered on 20 July 2017.

Project description:BackgroundSmoking in pregnancy is a major public health concern. Pregnant smokers are particularly difficult to reach, with low uptake of support options and few effective interventions. Text message-based self-help is a promising, low-cost intervention for this population, but its real-world uptake is largely unknown.ObjectiveThe objective of this study was to explore the uptake and cost-effectiveness of a tailored, theory-guided, text message intervention for pregnant smokers ("MiQuit") when advertised on the internet.MethodsLinks to a website providing MiQuit initiation information (texting a short code) were advertised on a cost-per-click basis on 2 websites (Google Search and Facebook; £1000 budget each) and free of charge within smoking-in-pregnancy webpages on 2 noncommercial websites (National Childbirth Trust and NHS Choices). Daily budgets were capped to allow the Google and Facebook adverts to run for 1 and 3 months, respectively. We recorded the number of times adverts were shown and clicked on, the number of MiQuit initiations, the characteristics of those initiating MiQuit, and whether support was discontinued prematurely. For the commercial adverts, we calculated the cost per initiation and, using quit rates obtained from an earlier clinical trial, estimated the cost per additional quitter.ResultsWith equal capped budgets, there were 812 and 1889 advert clicks to the MiQuit website from Google (search-based) and Facebook (banner) adverts, respectively. MiQuit was initiated by 5.2% (42/812) of those clicking via Google (95% CI 3.9%-6.9%) and 2.22% (42/1889) of those clicking via Facebook (95% CI 1.65%-2.99%). Adverts on noncommercial webpages generated 53 clicks over 6 months, with 9 initiations (9/53, 17%; 95% CI 9%-30%). For the commercial websites combined, mean cost per initiation was £24.73; estimated cost per additional quitter, including text delivery costs, was £735.86 (95% CI £227.66-£5223.93). Those initiating MiQuit via Google were typically very early in pregnancy (median gestation 5 weeks, interquartile range 10 weeks); those initiating via Facebook were distributed more evenly across pregnancy (median gestation 16 weeks, interquartile range 14 weeks).ConclusionsCommercial online adverts are a feasible, likely cost-effective method for engaging pregnant smokers in digital cessation support and may generate uptake at a faster rate than noncommercial websites. As a strategy for implementing MiQuit, online advertising has large reach potential and can offer support to a hard-to-reach population of smokers.

Dataset Information

Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

Publications

Assessment of the Effectiveness and Cost-Effectiveness of Tailored Web- and Text-Based Smoking Cessation Support in Primary Care (iQuit in Practice II): Protocol for a Randomized Controlled Trial.

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