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

Summary

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.

Conditions

• Tobacco Use Cessation
• Tobacco Use Disorder
• Nicotine Dependence
• Smokeless Tobacco Use

Interventions

BEHAVIORAL

QuitAid (pharmacist-delivered MTM)

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.

DRUG

Nicotine Replacement Therapy (NRT)

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Virginia

  lead OTHER

Principal Investigators

• Melissa A Little, PhD, MPH · University of Virginia

• Drew Harris, MD · University of Virginia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-09-30

Completion

2027-12-31

Countries

• United States

Study Locations