Feasibility of a Medical-Legal Partnership Model to Connect Coal Miners QuitAid

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• QuitAid + NRTTreatment being tested

  Participants receive the pharmacist-delivered QuitAid MTM program plus 24 weeks of NRT. Those ready to quit receive six telephonic coaching sessions over 4 weeks; those not ready to quit receive up to three Pre-Quit Motivation Modules and may transition to QuitAid upon reporting readiness at a weekly check-in (Weeks 1-4).

  Treatment: QuitAid (pharmacist-delivered MTM) and Nicotine Replacement Therapy (NRT)

• NRT OnlyExisting treatment, for comparison

  Participants receive 24 weeks of NRT beginning in Week 1 without the QuitAid MTM program. All follow-up assessments are conducted regardless of condition.

  Treatment: Nicotine Replacement Therapy (NRT)