Discussion
SECONDARY
The purpose of this SMART was to generate data to select components for an evidence-based adaptive intervention for smoking cessation treatment in the LCS setting. Among participants who did not respond to the initial TLC treatment, there were no significant differences in long-term or short-term abstinence between TLC with or without the availability of prescription medications. Among participants who did respond to the initial TLC treatment, results suggested that TLC was more effective with at least monthly contact than quarterly contact, but the difference was not statistically significant. Clinically meaningful long-term quit rates were observed across TLC intervention groups. Based on the findings from these primary analyses, TLC was most effective when implemented without modification in the LCS setting.Findings from PLUTO inform how to design effective smoking cessation programs in the LCS setting. Based on the primary analyses, there is no evidence to suggest that setting up a referral program for participants to see a pharmacist for MTM (and possible prescription medications for smoking cessation) would yield much benefit. This may have implications for resource allocation because combination NRT is available over the counter and can be dispensed by trained staff, which is less resource intensive than providing prescription medications that require licensed clinicians. There are several potential explanations for these findings. Among early treatment nonresponders, only 39% of participants completed at least 1 MTM visit. Baseline characteristics show that most participants had previously tried prescription medications; perhaps lack of prior success with medications influenced this decision. While prescription medication use was higher in TLC with MTM than in TLC, a number of participants (18.8% of those not randomized to MTM) accessed these medications outside the study (eg, through their health care clinician). Additionally, most participants used considerable amounts of combination NRT, and availability of prescription medications might not have provided important benefit in this context. This could be because coaches promoted combination NRT, it was free of cost, and/or combination NRT is equally effective to prescription medications. However, this finding may not be generalized to populations with limited access to care and prescription medications. Future research should assess whether there are subgroups who would benefit from referral to MTM to access prescription medications.The comparison of TLC and Quarterly TLC for early responders suggest monthly follow-up confers long-term cessation advantage. The estimated difference of 14% in abstinence rates was not statistically significant, however, it is clinically significant, and this secondary analysis was underpowered. Based on this result, we recommend that clinicians do not step down to quarterly contact among early responders to TLC. It is likely that, even among early treatment responders, attention to relapse prevention, management of smoking lapses, and adjustment of NRT is important.The results of PLUTO are important because they support feasibility and utility of using a chronic care model of tobacco treatment that incorporates medications and intensive counseling. Meaningful long-term quit rates (24.4%, 6-month prolonged abstinence) and short-term quit rates (36.1%, 7-day point prevalence abstinence) were observed overall across TLC groups and these rates compare favorably with other smoking cessation trials in the LCS setting. For example, Taylor et al