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

NCT07694492 | Not Yet Recruiting

• 2 other identifiers: HSR 3030715P30CA044579-30
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Tobacco Use Disorder; Smokeless Tobacco Use; Nicotine Dependence

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Self-Reported Tobacco Abstinence

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

• Quit Attempts

  Baseline through 26 weeks

• Frequency of Urges to Use TNPs

  Baseline through 26 weeks

• Adherence to Assigned Treatment(s)

  Baseline through 26 weeks

• Adherence to NRT

  Baseline through 26 weeks

Other Outcomes (1)

• Program satisfaction

  26 weeks

Study Arms (2)

QuitAid + NRT

EXPERIMENTAL

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); Drug: Nicotine Replacement Therapy (NRT)

NRT Only

ACTIVE COMPARATOR

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)

Interventions

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.

Also known as: Medication Therapy Management (MTM)

QuitAid + NRT

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.

NRT Only; QuitAid + NRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use Disorder; Smoking Cessation; Anthracosis

Interventions

Medication Therapy Management; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration; Drug Therapy; Therapeutics

Study Officials

• Melissa A Little, PhD, MPH

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Drew Harris, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley N DeMoss, MPH

CONTACT

(304) 574-8073; fzv3nn@virginia.edu

Dylan Allanson, MPH, RD

CONTACT

4342430424; da4ac@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Public Health Sciences Director, Center for Tobacco Prevention and Control Research

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)