Effectiveness of different models of smoking cessation advice for improving quit rates in Macedonia: a randomized controlled trial (protocol)

Abstract

Research question: Does additional assessment and feedback of lung age or exhaled CO levels among smokers in primary care increase their likelihood of quitting smoking compared to giving very brief smoking cessation advice (VBA) alone? Background: Smoking cessation is important for disease prevention and primary care physicians play a key role. In low resource settings where pharmacotherapy is unavailable and NRT is expensive, alternative smoking cessation interventions are needed. Presenting smokers with personalized evidence of the harmful effects of smoking might encourage cessation; potential interventions include feedback on lung age and exhaled carbon monoxide (CO). Possible methodology: Design: Individually randomized controlled trial with process evaluation and cost effectiveness analysis. Population: Current smokers (≥10 cigarettes per day), aged ≥35 years. Recruitment: Patients will be recruited from 30 GP offices in Macedonia. 885 smokers who are attending for any reason and fit the eligibility criteria, regardless of their motivation to quit smoking, will be invited to take part. Intervention: Patients will be randomly allocated to 3 groups; i) VBA + lung age, ii) VBA + exhaled CO, iii) VBA alone (control). Patients in each group will be assessed at baseline, 1 and 6 months. Outcome measures: Primary outcome is smoking cessation at 1 month, confirmed by exhaled CO≤10ppm. Secondary outcomes include quit attempts at 1 month, smoking cessation at 6 months, reduction in number of cigarettes smoked per day at 1 month and 6 months, motivation to quit at 1 month and 6 months and, quality of life at 1 month and 6 months. Questions to discuss: How best to monitor fidelity of the intervention delivery? Is there a risk of contamination between intervention arms and how could this be assessed and addressed?