Clinical trial NCT05660525: Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
Official title: Leveraging Community Pharmacists to Optimize Smoking Cessation Services for Rural Smokers in Appalachia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Smoking, Cigarette
Smoking Reduction
Smoking
Smoking, Tobacco
Quitting Smoking
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 768
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2x2x2x2
Primary purpose: TREATMENT

Brief 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

Detailed 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).

Eligibility 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)

Primary outcomes:
measure: Tobacco Abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Self-Reported Tobacco Abstinence
timeFrame: 1, 2, and 3 months
measure: Adherence to assigned treatment components
timeFrame: 1, 2, and 3 months
measure: Quit Attempts
timeFrame: 1, 2, and 3 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Melissa Little, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: