Nicotine Dependence, Smokeless Tobacco Use, Tobacco Use Cessation, Tobacco Use Disorder
Conditions
Keywords
Smoking Cessation, Lawyers, medical-legal partnership;, ask-advise-connect, pharmacist-delivered intervention, coal miners, medication therapy management (MTM), nicotine replacement therapy, QuitAid, tobacco and nicotine products, Central Appalachia, black lung, workers' compensation, feasibility pilot
Brief 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.
Detailed description
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 time constraints, limited provider buy-in, and patient factors limit adoption. In workers' compensation cases, claimants must prove their disease results from coal-dust exposure rather than TNP use, which creates both a health and a financial incentive for cessation and gives the miner-lawyer relationship unusual salience. This study leverages that relationship by having lawyers ask about TNP use (already routine at intake), advise quitting, and connect interested clients to a pharmacist-delivered cessation program (the novel component). QuitAid, previously developed and piloted by the study team, is a pharmacist-delivered MTM intervention designed to increase NRT adherence and promote cessation. Aim 1 (implementation evaluation, lawyers). Guided by the Consolidated Framework for Implementation Research (CFIR), the team evaluates facilitators and barriers to adopting the ask-advise-connect model in approximately three black-lung law offices. Lawyers (up to 5 enrolled) complete baseline and follow-up surveys assessing self-efficacy, attitudes, and perceived facilitators/barriers, and participate in \ 30-minute semi-structured telephone interviews (audio-recorded, analyzed thematically). Recruitment feasibility is measured by the proportion of coal miners referred per office and the number enrolled per month. Lawyers are study participants only, not investigators, and referral has no effect on a miner's legal case. Aim 2 (randomized feasibility pilot, coal miners). Coal miners who use TNPs and have a current black-lung workers' compensation case with a participating law office are referred, screened, and consented by phone, complete a baseline assessment, and are then randomized 1:1 via computer-generated permuted-block randomization (generated in R, embedded in REDCap) to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT beginning in Week 1 regardless of readiness to quit. Participants use of smoked TNPs (cigarettes, e-cigarettes, little cigars, cigarillos, cigars) receive the long-acting NRT patch; those using oral TNPs (smokeless tobacco, nicotine pouches) receive short-acting NRT gum; those using both receive the patch. Participants randomized to QuitAid who are ready to quit receive six telephonic pharmacist coaching sessions over 4 weeks; those not ready to quit receive up to three telephonic Pre-Quit Motivation Modules and may transition to QuitAid if they report readiness at any weekly check-in during Weeks 1-4. If readiness is not reported after four weekly check-ins, QuitAid ends. Follow-up assessments are conducted with all participants at 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks via secure REDCap links or telephone. Because this is a feasibility pilot, secondary clinical outcomes are analyzed descriptively and with logistic regression only to inform a future full-scale trial.
Interventions
BEHAVIORALQuitAid (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.
DRUGNicotine 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
University of Virginia
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm randomized feasibility pilot. Participants are randomized 1:1 to QuitAid (Yes vs. No). All participants receive 24 weeks of NRT. The trial is a feasibility pilot and is not powered to detect between-arm differences; primary outcomes are process/feasibility measures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 worsening angina, or very rapid or irregular heartbeat requiring medication) * Pregnant or breastfeeding, or planning to become pregnant during the next 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Randomization | Through study recruitment (approximately 6 months) | Number of coal miners who need to be approached and screened in order to randomize 100 TNP users. |
| Retention | 26 weeks | Proportion of randomized coal miners who complete the 26-week follow-up visit. |
| Fidelity of Implementation | Through the 4-week intervention period | 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. |
| Dose of the Medication Therapy Management (MTM) Intervention | Through the 4-week intervention period | Number of MTM (QuitAid) sessions received per participant, documented in the REDCap database. |
| Dose of NRT | Baseline through 26 weeks | Reported proportion of provided NRT that was used by participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Tobacco Abstinence | 1, 2, 3, 4, 7, 11, 15, 19, and 26 weeks | Self-reported abstinence, defined as no use of any tobacco or nicotine products within the past 7 days. |
| Quit Attempts | Baseline through 26 weeks | 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). |
| Frequency of Urges to Use TNPs | Baseline through 26 weeks | Self-reported frequency of urges to use tobacco/nicotine products. |
| Adherence to Assigned Treatment(s) | Baseline through 26 weeks | Percentage of intervention sessions completed and percentage of provided NRT used. |
| Adherence to NRT | Baseline through 26 weeks | Adherence to NRT (patch or gum), measured as the percentage of provided NRT used. |
| Strength of urges to use TNPs | Baseline through 26 weeks | Self-reported strength of urges to use tobacco/nicotine products. |
Countries
United States
Contacts
CONTACTAshley N DeMoss, MPH
CONTACTDylan Allanson, MPH, RD
PRINCIPAL_INVESTIGATORMelissa A Little, PhD, MPH
University of Virginia
PRINCIPAL_INVESTIGATORDrew Harris, MD
University of Virginia
Outcome results
None listed