A randomised controlled trial to assess the effectiveness and cost-effectiveness of tailored web- and text-based smoking cessation support in primary care: iQuit in Practice II trial protocol (Preprint)

Proctor, Joanna; Naughton, Felix; Sloan, Melanie; Hopewell, Sarah; Brimicombe, James; Prevost, Toby; Wilson, Ed; Coleman, Tim; Sutton, Stephen

Abstract

Background: The prevalence of smoking is in decline, however, it continues to be a major public health burden. In England, primary care is the health setting that provides smoking cessation support to the 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 demonstrated feasibility, acceptability and potential effectiveness in an earlier trial. The aim of this definitive trial is to determine the effectiveness and cost effectiveness of iQuit compared to usual care alone.

Objective: The aim of this study is to assess the effectiveness and cost-effectiveness of iQuit when delivered alongside usual care compared with usual care alone.

Methods: The iQuit in Practice II trial is a two parallel-group randomised controlled trial (RCT) with 1:1 individual allocation comparing usual care, pharmacotherapy combined with multi-sessional behavioural support (Control), with usual care plus iQuit (Intervention). Participants are recruited from GP practices and seen by a smoking cessation advisor (SCA). Participants are randomised during the initial consultation and those allocated to the intervention group receive a tailored advice report and 90 days of text messaging in addition to the standard support given to all patients. The primary outcome is self-reported prolonged abstinence biochemically verified using saliva cotinine at 6-monthsafter randomisation. A sample size of 1,700, 850 per arm, would give 90% power to detect a 4.3% difference in validated quit rates between the groups at the two-sided 5% level of significance.

Results: No results are available at this present time, the trial is still ongoing.

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 SCAs 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 behavioural support is delivered. Clinical Trial: ISRCTN44559004

• Deposit Date: Feb 15, 2023
• Public URL: https://nottingham-repository.worktribe.com/output/4279520
• Publisher URL: https://preprints.jmir.org/preprint/17160