Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

Smoking Cessation Clinical Trial

Official title: Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (medication therapy management) approach, called QuitAid, to quitting cigarette smoking in rural Appalachia.

The main questions it aims to answer are:

• Is QuitAid, alone or combined with other quitting tobacco treatments, effective?

• What makes QuitAid easy or hard to carry out? Is it cost effective? Is it easy to maintain?

Treatment:

All participants will be given at least 4 weeks of the nicotine patch.

Some participants will be randomized (like the flip of a coin) to receive additional treatments (listed below).

These groups will be compared to each other to see which combination works best to help them quit smoking.

• Smokefree TXT - a texting program that helps people quit smoking

• Tobacco quitline - 4 phone sessions to help people quit smoking

• 8 weeks of NRT (nicotine replacement therapy in the form of nicotine patches or nicotine patches and lozenge) medication instead of 4 weeks

• QuitAid - An MTM program given by the patient's pharmacist. This is a quitting smoking coaching program

• Nicotine patch AND nicotine lozenge instead of just nicotine patches

Clinical Trial Description

The proposed study uses a mixed-method design to evaluate the effectiveness and implementation of a pharmacist-delivered MTM (Medication Therapy Management) approach, called QuitAid, to smoking cessation in rural Appalachia. Aim 1 of this project will evaluate the effectiveness of QuitAid and standard, evidence-based tobacco treatments on cessation within an MTM pharmacist-delivered approach. Aim 2 will assess implementation, including relative cost of QuitAid, as well as standard, evidence-based tobacco treatments through an ask-advise-connect model, in community pharmacies, and will examine facilitators and barriers to reach, adoption, and maintenance of QuitAid as well as standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies.

Smokers (n=768) recruited through 14 community pharmacies in rural Appalachia will be randomized in a 2x2x2x2x2 full factorial experiment to the following five treatments: (1) QuitAid Intervention (Yes vs. No), (2) tobacco quitline (Yes vs. No), (3) SmokefreeTXT through the National Cancer Institute's (NCI) Smokefree.gov initiative (Yes vs. No), (4) Combination NRT Lozenge + NRT Patch (vs. NRT patch alone), and/or (5) 8 weeks of NRT (vs. standard 4 weeks). Following the experimental trial, we will use an implementation science approach to assess implementation, including relative cost, as well as facilitators and barriers of reach, adoption, and maintenance of QuitAid and standard, evidence-based tobacco treatments through an ask-advise-connect method in community pharmacies (Aim 2). ;

Related Conditions & MeSH terms

• Quitting Smoking
• Smoking
• Smoking Cessation
• Smoking Reduction
• Smoking, Cigarette
• Smoking, Tobacco

• NCT number: NCT05660525
• Study type: Interventional
• Source: University of Virginia
• Contact: Melissa Little, PhD, MPH
• Phone: 434-924-1935
• Email: mal7uj@virginia.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Completion date: March 1, 2028