Clinical trial NCT06161675: Feasibility of Delivering VergeRx at FQHCs
Official title: Determining the Feasibility of Delivering VergeRx to Smokers Through Pharmacies in Federally Qualified Health Centers Regardless of Readiness to Quit
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: Federally Qualified Health Center
Rural
Appalachia
Smoking Cessation
Readiness to Quit
Pharmacists
Pharmacies
Low Income
Medicaid
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomized via computerized block design after consenting to the study. Equal allocation across treatment combinations will be used and balance between treatment combinations will be maintained by use of randomly permutated blocks. The randomization is not blinded, the study team will know what conditions each subject is randomized to. The randomization schemes will be generated using the R statistical package and will be incorporated into the REDCap database prior to initiation of the study.
Primary purpose: TREATMENT

Brief summary: Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare services to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco and are required to report tobacco use screening rates and their delivery of cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers, particularly smokers who are not currently seeking treatment. To address this gap, the investigators developed a pharmacist-delivered smoking cessation intervention to help facilitate nicotine replacement therapy medication adherence among smokers. The proposed study aims to examine the feasibility of delivering the pharmacist-delivered smoking cessation intervention to FQHC patients who are ready to quit, and expanding the intervention for smokers not ready to quit by adding 2 pre-quit sessions focused on rate reduction. The investigators will also determine facilitators and barriers to adopting and implementing the program in FQHCs.

Detailed description: Cigarette smoking in the U.S. is highest among low income and Medicaid insured adults, and unfortunately, low-income smokers are even less likely to attempt to quit, less likely to use evidence-based treatments, and thus less likely to be successful. Federally Qualified Health Centers (FQHCs), which generally provide healthcare to low income and Medicaid insured patients, are more likely to serve individuals who use tobacco, and are required to report tobacco use screening rates and deliver cessation interventions. Thus, FQHCs are an ideal community-partner to reach low-income smokers. The investigators developed a pharmacist-delivered medication management program for smoking cessation to help facilitate nicotine replacement therapy medication adherence, and the investigators piloted the program in a rural Appalachian community pharmacy and found that the intervention was acceptable and feasible to pharmacists and smokers. The investigators are currently testing the effectiveness of the intervention along with standard, evidence-based tobacco treatments among rural smokers in Appalachia with a pharmacist-delivered approach in a R01 funded by NCI (R01CA267963, PI Little). However, given the low-income population served by FQHCs, there are likely unique barriers to smoking cessation in this setting. The investigators examined tobacco cessation services at pharmacies within FQHCs as well as potential barriers and facilitators to implementing a QuitAid program in this setting. The investigators found that only 43.5% provided smoking cessation to patients, and these services were limited to help seeking only smokers who were ready to quit. Thus, an opportunity exists to utilize pharmacists at FQHCs to maximize the reach of smoking cessation interventions, to both smokers ready to quit and those who are not yet ready to quit. The proposed study builds logically on this preliminary work by examining the feasibility of delivering a pharmacist-delivered medication management program for smoking cessation to FQHC patients who are ready to quit, and expanding this research for smokers who are not ready to quit by adding 2 pre-quit sessions focused on Rate Reduction (RR). Thus, the aims of the current study are: (1) Determine the feasibility of implementing a pharmacist-delivered medication management program for smoking cessation for smokers ready to quit and for smokers not ready to quit in FQHC pharmacies; and (2) Use an implementation science approach to determine facilitators and barriers to adopting and implementing a pharmacist delivered smoking cessation program in FQHCs. The proposed work will provide foundational evidence for a larger trial to determine the efficacy of these interventions.

Eligibility criteria: Inclusion Criteria:

* patient at participating Federally Qualified Health Center
* ≥18 years of age
* able to read, speak, and understand English
* report smoking ≥5 cigarettes per day for the past 6 months
* own a cell phone
* 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:

* 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: Feasibility of Recruitment
timeFrame: 6 months
measure: Feasibility of Randomization
timeFrame: 6 months
measure: Feasibility of Retention
timeFrame: 12 weeks
measure: Dose of the MTM intervention
timeFrame: 12 weeks
measure: Dose of the NRT
timeFrame: 12 weeks
measure: Dose of SmokefreeTXT
timeFrame: 12 weeks
Secondary outcomes:
measure: Biochemical Verification of Tobacco Abstinence by Participants
timeFrame: 12 weeks
measure: Quit Attempts
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Melissa A Little, PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: