University of Virginia
Coal miners in Central Appalachia have among the highest rates of tobacco and nicotine product (TNP) use of any occupational group and face elevated rates of lung cancer and coal workers' pneumoconiosis ("black lung"). This study tests a novel medical-legal partnership (MLP) that "flips" the traditional referral direction: lawyers representing coal miners in black-lung workers' compensation cases identify clients who use TNPs and, through an ask-advise-connect process, connect them to community pharmacists who deliver QuitAid, a pharmacist-delivered medication therapy management (MTM) program, together with nicotine replacement therapy (NRT). The study has two aims: (1) an implementation-science evaluation of the ask-advise-connect process in black-lung law offices, and (2) a randomized feasibility pilot in which coal miners who use TNPs are randomized to receive QuitAid or not, with all participants receiving 24 weeks of NRT. As a feasibility pilot, the study is designed to estimate recruitment, randomization, retention, fidelity, and dose parameters to inform a future NCI R01, and is not powered to detect differences between conditions.
Background and rationale. Lung cancer rates are approximately 25% higher in Central Appalachia than in the rest of the U.S., and black-lung mortality has been markedly elevated in the region. Coal miners report the highest rates of cigarette smoking (about 23% vs. \~14% nationally) and smokeless tobacco use (about 23% vs. \~3% nationally) of any U.S. occupation, and TNP use magnifies the risk and severity of obstructive lung disease and lung cancer in this already high-risk group. National guidelines recommend that clinicians refer TNP users to cessation services via ask-advise-connect, but ti…
Inclusion Criteria: * Age ≥ 18 years * Able to read, speak, and understand English * A coal miner who uses tobacco and nicotine products, lives in the U.S., and has a current black-lung workers' compensation case with a participating law office * Reports using tobacco and nicotine products daily for the past 6 months * Willing and able to use NRT in the form of patch or gum * Not pregnant or planning to become pregnant in the next 6 months Exclusion Criteria: * Medical contraindication to NRT (e.g., within the past 30 days: heart attack or stroke; within the past 6 months: serious or worsen…
Six telephonic pharmacist coaching sessions over 4 weeks focused on setting a quit date and quitting TNPs. The first session (and subsequent proactive calls at \~days 2, 7, 14, 21, and 28) addresses negative beliefs about NRT, strengthens motivation and commitment to NRT use, monitors NRT use, provides feedback, and supports adherence. Includes the Pre-Quit Motivation Modules (up to three telephonic sessions) for participants not yet ready to quit.
24 weeks of NRT dispensed under a standing order and mailed to participants, with standard use guidelines. Product is matched to TNP type: long-acting patch for smoked TNP users, short-acting gum for oral TNP users, patch for dual users.