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

University of Virginia

Status: Enrolling

Conditions: Quitting Smoking; Smoking, Cigarette; Smoking Reduction; Smoking, Tobacco; Smoking; Smoking Cessation

Treatments: Behavioral: Tobacco Quitline; Drug: 8 weeks of Nicotine Replacement Therapy Patch; Drug: 4 weeks of Nicotine Replacement Therapy Patch; Behavioral: Smokefree TXT; Drug: 4 weeks of Nicotine lozenge; Drug: 8 Weeks Nicotine Lozenge; Behavioral: QuitAid

Study type: Interventional

Funder types: Other

Identifiers

NCT05660525

HSR220197

Details and patient eligibility

About

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

Full 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).

Enrollment: 768 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Study participants will be rural cigarette smokers from Virginia, Tennessee, Kentucky and North Carolina who visit one of the participating study pharmacies. Pharmacies will be located in rural geographic areas of the Central and South Central subregions of Appalachia that include Virginia, Tennessee, Kentucky and North Carolina, as defined by the USDA Rural-Urban Continuum Codes (RUCC) 4-9, Rural-Urban Commuting Area (RUCA) codes 4-10, or Frontier and Remote (FAR) areas level 4. No exclusionary criteria are based on race, gender, or age.

Inclusion Criteria include:

• must be 18 years of age and older
• must be able to read, speak, and understand English
• must report smoking at least 5 cigarettes per day for the past 6 months (regardless of non-cigarette tobacco product use)
• must be willing to set a quit date within the next 30 days
• must own a cell phone
• must be willing and able to use NRT in the form of patch or lozenge
• Not be pregnant or planning to be pregnant in the next 6 months.

Exclusion Criteria include:

• are pregnant women (self-reported), breastfeeding, planning to become pregnant during the next 6 months
• have a medical contraindication to NRT (e.g., past 30 days, heart attack or stroke; past 6 months, serious or worsening angina, very rapid or irregular heartbeat requiring medication)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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768 participants in 32 patient groups

QuitAid, 4 weeks, Patch + Lozenge

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.

Treatment:

Behavioral: QuitAid

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.

Treatment:

Behavioral: QuitAid

Drug: 8 Weeks Nicotine Lozenge

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch + Lozenge, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention

Treatment:

Behavioral: QuitAid

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

QuitAid, 8 weeks, Patch + Lozenge, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention

Treatment:

Behavioral: QuitAid

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Treatment:

Behavioral: QuitAid

Drug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Treatment:

Behavioral: QuitAid

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention

Treatment:

Behavioral: QuitAid

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention

Treatment:

Behavioral: QuitAid

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

QuitAid, 4 weeks, Patch, SmokeFree Txt

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch, SmokeFree Txt

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.

Treatment:

Behavioral: QuitAid

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Smokefree TXT

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: QuitAid

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Smokefree TXT

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: QuitAid

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Smokefree TXT

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: Smokefree TXT

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

4 weeks, Patch, SmokeFree Txt, QuitLine

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.

Treatment:

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

8 weeks, Patch + Lozenge, QuitLine

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Treatment:

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch, QuitLine

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Treatment:

Behavioral: Tobacco Quitline

Drug: 8 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch + Lozenge, QuitLine

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.

Treatment:

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

4 weeks, Patch, QuitLine

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.

Treatment:

Drug: 4 weeks of Nicotine Replacement Therapy Patch

Behavioral: Tobacco Quitline

8 weeks, Patch + Lozenge, SmokeFree Txt

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.

Treatment:

Drug: 8 Weeks Nicotine Lozenge

Behavioral: Smokefree TXT

Drug: 8 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch, SmokeFree Txt

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Treatment:

Behavioral: Smokefree TXT

Drug: 8 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch + Lozenge, SmokeFree Txt

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.

Treatment:

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch, SmokeFree Txt

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.

Treatment:

Behavioral: Smokefree TXT

Drug: 4 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch + Lozenge

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Treatment:

Drug: 8 Weeks Nicotine Lozenge

Drug: 8 weeks of Nicotine Replacement Therapy Patch

8 weeks, Patch

Experimental group

Description:

Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Treatment:

Drug: 8 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch + Lozenge

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.

Treatment:

Drug: 4 weeks of Nicotine lozenge

Drug: 4 weeks of Nicotine Replacement Therapy Patch

4 weeks, Patch

Experimental group

Description:

Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.

Treatment:

Drug: 4 weeks of Nicotine Replacement Therapy Patch