Rural Appalachian populations have the highest rates of cigarette smoking in the U.S. and are disproportionately affected by tobacco-related cancers. Publicly available smoking cessation resources (e.g., state quitlines, text-based interventions, nicotine replacement therapy [NRT]) are under-utilized by rural Appalachian smokers. Furthermore, rural Appalachia is medically underserved; thus, smoking cessation services within primary care settings face additional barriers. Community pharmacists, with their centralized placement in local communities and clinical expertise, are ideally situated to build capacity in underserved areas such as rural Appalachia to enhance existing smoking cessation resources for smokers. Research on pharmacist-delivered smoking cessation interventions is limited and does not provide for documentation and billing to compensate pharmacists for their time spent counseling patients. Medication Therapy Management (MTM), a pharmacist-delivered medication adherence approach that allows pharmacists to receive compensation for providing medication expertise, could be leveraged to promote smoking cessation. To address this gap, we developed an MTM intervention, QuitAid, to increase smoking cessation among rural smokers. QuitAid was based on a medication adherence intervention shown to be efficacious in a quitline setting. The purpose of the proposed study is to use a pragmatic approach, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, to identify the essential components of an effective smoking cessation program that can easily integrate within community pharmacies in underserved rural areas. Smokers (n=768) recruited through 14 community pharmacies in rural Appalachia will be randomized in a 25 full factorial experiment to the following five treatments: (1) QuitAid (Yes vs. No), (2) tobacco quitline (Yes vs. No), (3) SmokefreeTXT (Yes vs. No), (4) Combination NRT Gum + NRT Patch (vs. NRT patch alone), and/or (5) 8 weeks of NRT (vs. standard 4 weeks). The primary outcome is biochemically- confirmed point prevalence abstinence at the 6-month follow-up. We will also assess implementation, including relative cost, as well as facilitators and barriers of reach, adoption, and maintenance of QuitAid and standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies. Our main hypothesis is that a smoking cessation MTM will increase smoking cessation and enhance reach and adherence to publicly available smoking cessation resources in medically underserved rural areas. The proposed study will: (1) provide foundational evidence for leveraging community pharmacists in underserved and rural areas to promote utilization of existing evidence-based tobacco cessation resources through enhanced MTM support, (2) inform updated national guidance on treating rural smokers, and (3) aid state legislation efforts related to pharmacy smoking cessation programs and policies. Ultimately, this research will inform strategies for smoking cessation in rural areas, such that cancer rates achieve parity with urban areas.

While there are publicly available smoking cessation resources (e.g., state quitlines, text-based interventions, nicotine replacement therapy [NRT]), these programs are under-utilized by rural Appalachian smokers. Community pharmacists may be ideally situated to identify, recruit, and refer these hard-to-reach smokers in rural areas to resources using an ask-advise-connect model and provide medication therapy management support for smoking cessation to enhance both the reach and effectiveness of existing tobacco cessation resources for smokers. The current proposal will accelerate scientific discovery and dissemination of widely available smoking cessation strategies by integrating treatment into community pharmacies in underserved rural areas of Appalachia, thus leading to significant improvement in smoking- related cancer health outcomes among high-risk rural smokers.