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

Determining the Feasibility of Utilizing a Medical-Legal Partnership Model to Reach Coal Miners Who Use Tobacco and Nicotine Products and Connect Them to a Pharmacy-based Cessation Program

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Disorder; Tobacco Use Cessation; Nicotine Dependence; Smokeless Tobacco Use
• Intervention / Treatment: Behavioral: QuitAid (pharmacist-delivered MTM); Drug: Nicotine Replacement Therapy (NRT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dylan Allanson, MPH, RD; Phone Number: 4342430424; Email: da4ac@virginia.edu
• Study Contact Backup: Name: Ashley N DeMoss, MPH; Phone Number: (304) 574-8073; Email: fzv3nn@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
      • Sub-Investigator: Roger T Anderson, PhD
      • Contact: Ashley N DeMoss, MPH; Phone Number: (304) 574-8073; Email: fzv3nn@virginia.edu
      • Principal Investigator: Melissa A Little, PhD, MPH
      • Principal Investigator: Drew Harris, MD
      • Sub-Investigator: Candace H Wood, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QuitAid + NRT; 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).	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.; Other Names: Medication Therapy Management (MTM); 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.
Active Comparator: NRT Only; Participants receive 24 weeks of NRT beginning in Week 1 without the QuitAid MTM program. All follow-up assessments are conducted regardless of condition.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Randomization	Number of coal miners who need to be approached and screened in order to randomize 100 TNP users.	Through study recruitment (approximately 6 months)
Retention	Proportion of randomized coal miners who complete the 26-week follow-up visit.	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.	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.	Through the 4-week intervention period
Dose of NRT	Reported proportion of provided NRT that was used by participants.	Baseline through 26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Tobacco Abstinence	Self-reported abstinence, defined as no use of any tobacco or nicotine products within the past 7 days.	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).	Baseline through 26 weeks
Frequency of Urges to Use TNPs	Self-reported frequency of urges to use tobacco/nicotine products.	Baseline through 26 weeks
Adherence to Assigned Treatment(s)	Percentage of intervention sessions completed and percentage of provided NRT used.	Baseline through 26 weeks
Adherence to NRT	Adherence to NRT (patch or gum), measured as the percentage of provided NRT used.	Baseline through 26 weeks
Strength of urges to use TNPs	Self-reported strength of urges to use tobacco/nicotine products.	Baseline through 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	26 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Melissa A Little, PhD, MPH, University of Virginia; Principal Investigator: Drew Harris, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: nicotine replacement therapy; Smoking Cessation; workers' compensation; Lawyers; medical-legal partnership;; ask-advise-connect; pharmacist-delivered intervention; coal miners; medication therapy management (MTM); QuitAid; tobacco and nicotine products; Central Appalachia; black lung; feasibility pilot
• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Diseases; Lung Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Lung Diseases, Interstitial; Lung Injury; Pneumoconiosis; Behavior; Health Behavior; Tobacco Use Disorder; Smoking Cessation; Tobacco Use Cessation; Anthracosis; Health Services Administration; Therapeutics; Drug Therapy; Health Services; Health Care Facilities Workforce and Services; Health Care Economics and Organizations; Patient Care Management; Financing, Organized; Economics; Pharmaceutical Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Medicare; Nicotine Replacement Therapy; Medication Therapy Management
• Other Study ID Numbers: HSR 303071; 5P30CA044579-30 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No