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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Medical contraindication to NRT (e.g., within the past 30 days: heart attack or stroke; within the past 6 months: serious or worsening angina, or very rapid or irregular heartbeat requiring medication)

Pregnant or breastfeeding, or planning to become pregnant during the next 6 months

Trial design

Treatments tested in this trial

  • QuitAid (pharmacist-delivered MTM)
  • Nicotine Replacement Therapy (NRT)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Virginia

Lead sponsor

National Cancer Institute (NCI)

Collaborator