Most smokers do not make a quit attempt in any given year. For those who do, use of evidence-based treatment, including the use of nicotine replacement therapy (NRT) is modest at best. Brief physician advice to quit, based on the 5As/5Rs model, while offering some efficacy, is inconsistently administered and thus has limited population impact. There is a clear need for more efficacious methods, particularly in the clinical setting, to promote quitting. Our team recently completed a large, nationwide clinical trial of NRT sampling, i.e., testing whether brief provision of NRT promotes further uptake of cessation behavior, higher incidence of quit attempts, and higher rates of abstinence. The results of that trial were promising for all outcomes, and suggested that NRT sampling works by increasing both motivation and confidence to quit and increasing familiarity with NRT products as an option for quitting. NRT sampling, when added to physician advice to quit, is uniquely suited to busy primary care settings for several reasons. First, primary care represents a prominent point of healthcare contact for a large number of smokers. Second, the sampling intervention is simple, takes only a few minutes to deliver, and requires minimal instructions. Third, unlike other clinic-based strategies such as motivational advice, NRT sampling is behaviorally based, and offers providers and patients, both of whom are often frustrated by persuasive messaging, a concrete experience to catalyze quitting. Fourth, sampling is supported by numerous quit line studies that show that free medications significantly increase call volume and cessation. Finally, sampling has a strong theoretical foundation to suggest that brief exposure to a product promotes wider acceptability of it. This competing renewal proposes a translational comparative effectiveness trial, testing standard care (Ask, Advise, Refer) vs. standard care + NRT sampling (2wk supply of both nicotine patch and lozenge). Working within an established network (based at our institution) of primary care providers who have all established infrastructure for coordinating clinical research, smokers will be recruited directly within clinic practices. Interventions will b delivered by clinic personnel, and prospective follow-up will be centrally coordinated by our research team, using established procedures that yield high rates of retention. Though we track a number of outcomes, our primary aims are to examine the impact of NRT sampling on smoking behavior: cessation, quit attempts, uptake of additional evidence-based treatment. Long, intensive treatments that combine behavioral and pharmacologic treatment have strong empirical support. However, they offer only partial utility because they do not readily lend themselves to real world primary care settings, where providers have limited time and expertise to address tobacco dependence. Improving the effectiveness and reach of brief intervention within primary care, as could be accomplished by NRT sampling, could have a major impact on population quit rates.
The primary care setting offers a powerful opportunity to identify smokers and engage them in the quitting process, with the ultimate goal to lower the burden of preventable disease. Based on significant and promising findings from a recently completed randomized clinical trial, this comparative effectiveness trial will test whether NRT sampling, i.e., provision of starter-kits of nicotine replacement therapy, when combined with standard physician advice to quit, results in significant improvements in smoking-related outcomes (abstinence, quit attempts, use of additional quit resources) as compared to quit advice alone. Positive findings could offer both clinical and policy significance.
