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

ConditionsTobacco Use Cessation Tobacco Use Disorder Nicotine Dependence Smokeless Tobacco Use

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

QuitAid (pharmacist-delivered MTM)
Behavioral
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.
Nicotine Replacement Therapy (NRT)
Drug
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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: QuitAid + NRTExperimental treatment 2 interventions

Group B: NRT OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

Feasibility of Randomization

Number of coal miners who need to be approached and screened in order to randomize 100 TNP users.

Time frame

Through study recruitment (approximately 6 months)

Retention

Proportion of randomized coal miners who complete the 26-week follow-up visit.

Time frame

26 weeks

Fidelity of Implementation

Fidelity of QuitAid delivery, assessed as adherence to QuitAid, quality of program delivery, participant responsiveness, and program differentiation, captured via a session checklist and self-reported end-of-session reflections.

Time frame

Through the 4-week intervention period

Dose of the Medication Therapy Management (MTM) Intervention

Number of MTM (QuitAid) sessions received per participant, documented in the REDCap database.

Time frame

Through the 4-week intervention period

Secondary outcomes

Self-Reported Tobacco Abstinence

Self-reported abstinence, defined as no use of any tobacco or nicotine products within the past 7 days.

Time frame

1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks

Quit Attempts

Number of quit attempts since the previous contact, where a quit attempt is abstinence for ≥24 hours not due to involuntary or forced cessation (e.g., hospitalization).

Time frame

Baseline through 26 weeks

Frequency of Urges to Use TNPs

Self-reported frequency of urges to use tobacco/nicotine products.

Time frame

Baseline through 26 weeks

Adherence to Assigned Treatment(s)

Percentage of intervention sessions completed and percentage of provided NRT used.

Time frame

Baseline through 26 weeks

Other outcomes

Program satisfaction

Participant-reported barriers to treatment utilization, satisfaction with treatment components, and suggestions for improvement, with items focused on perceived capacity and opportunity to engage with the interventions.

Time frame

26 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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