Nicotine replacement therapy sampling for smoking cessation within primary care: results from a pragmatic cluster randomized clinical trial

Abstract

Background and Aims Within the context of busy clinical settings, health‐care providers need practical, evidence‐based options to engage smokers in quitting. Sampling of nicotine replacement therapy [i.e. provision of nicotine replacement therapy (NRT starter kits)] is a brief, pragmatic strategy to address this need. We aimed to compare the effects of NRT sampling plus standard care (SC), relative to SC alone, provided by primary care providers during routine clinic visits. Design Cluster‐randomized clinical trial. Setting Twenty‐two primary care clinics in South Carolina, USA. Participants Adult smokers [n = 1245; 61% female, mean age = 50.7, standard deviation (SD) = 13.5] both motivated and unmotivated to quit, seen during routine clinical visit. Interventions were provider‐delivered SC (n = 652, 12 clinics) cessation advice or SC + a 2‐week supply of both nicotine patch and lozenge, with minimal instructions on use (n = 593; 10 clinics). Measurements The primary outcome was 7‐day point prevalence smoking abstinence at 6‐month follow‐up, using intent‐to‐treat. Additional outcomes included NRT use and quit attempts, assessed at 1, 3 and 6 months following baseline. Findings Seven‐day point prevalence abstinence rates were significantly higher in the NRT sampling group throughout follow‐up, including at 6 months [12 versus 8%, odds ratio (OR) = 1.5, 95% confidence interval (CI) = 1.0–2.4]. NRT sampling increased prevalence of any use of NRT (65 versus 25%, OR = 5.8, 95% CI = 4.3–7.7), with higher prevalence of use at 6 months (25 versus 14%, OR = 2.0, 95% CI = 1.5–2.7). NRT sampling increased the rate of quit attempts in the initial month (24 versus 18%, OR = 1.5, 95% CI = 1.0–2.3) but had no significant effect on overall rate of quit attempts (48 versus 45%, OR = 1.2, 95% CI = 0.8–1.7). Conclusion Providing smokers with a free 2‐week starter kit of nicotine replacement therapy increased quit attempts, use of stop smoking medications and smoking abstinence compared with standard care in a primary care setting.

Remote Methods for Conducting Tobacco-Focused Clinical Trials

“…First, particularly for trials in which there is some potential for study-related risks, adverse event monitoring is critical. Trials have begun to implement remote procedures for adverse event monitoring including via phone and automated electronic surveys, 21 but there is great potential to improve real-time adverse event monitoring and response to such events within the context of remote trials. Second, for tobacco-focused trials, innovating methods for real time, continuous, remote measurement of cotinine will improve the options for remote biochemical verification of tobacco use status and address limitations to current remote cotinine collection options.…”

“…In our own prior studies that have utilized mailed consent procedures, return rates have been somewhat low, with nonresponse rates of approximately 45%–50%. 21 , 22 To improve upon this process, we are currently exploring the added utility of a $5 noncontingent incentive, mailed with consent forms in a similar manner as many paper-based household surveys are conducted. 23 , 24 Study recruitment is ongoing and early results should be interpreted with caution; nonetheless, among mailed consent forms sent to date (775 total), response rates to mailings with the $5 incentive versus not have been 45.5% versus 35%, which equates to a cost of $48.78 per additional participant enrolled.…”

Does Medication Sampling Improve Compliance with Brief Advice? Results from a Pragmatic Randomized Clinical Trial

“…In summary, this large randomized clinical trial examined medication sampling as a brief and disseminable treatment to promote smoking cessation in primary care. Patient outcomes of medication sampling were favorable [ 17 ], with an increase in medication uptake and cessation at six months. Analyses herein provide further support for medication sampling at the provider level: sampling is a useful tool that more effectively allows healthcare providers to concretely assist their patients with smoking cessation.…”

“…We report herein on receipt of cessation advice from a recently completed cluster randomized clinical trial that evaluated the impact of medication sampling on patient outcomes. Both the study methods [ 16 ] and participant-based outcomes [ 17 ] are reported elsewhere. While medication sampling was hypothesized to promote smoking abstinence at the patient level (and resulted in 1.5-fold increase in cessation), it was secondarily hypothesized to increase compliance with brief advice guidelines, insofar that giving providers a concrete, immediately actionable tool to offer to their patients might facilitate a deeper and more impactful conversation about quitting.…”

Commentary on Guillaumier et al. (2020): Is harm reduction a suitable outcome for historically hard‐to‐treat smokers?

“…Finally, the low‐burden practice of medication sampling (e.g. providing a 2‐week starter pack of nicotine replacement therapy) without intensive co‐occurring counseling has been shown to increase quit attempts and abstinence with little training required [18]. Although it is not harm reduction per se , medication sampling is an example of a pragmatic strategy that could catalyze cessation behavior, even among unmotivated smokers.…”