Feasibility of Delivering VergeRx at FQHCs

Determining the Feasibility of Delivering VergeRx to Smokers Through Pharmacies in Federally Qualified Health Centers Regardless of Readiness to Quit

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Behavioral: QuitAid; Behavioral: SmokefreeTXT; Drug: Nicotine Replacement Therapy Patch; Drug: Nicotine lozenge

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dylan Allanson, MPH, RD; Phone Number: 4342430424; Email: da4ac@virginia.edu
• Study Contact Backup: Name: Leslie A Gladney, MA; Email: lag3z@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
      • Principal Investigator: Melissa A Little, PhD,MPH
      • Contact: Dylan D Allanson, MPH, RD; Email: da4ac@virginia.edu
      • Sub-Investigator: Rebecca A Krukowski, PhD, MA
      • Sub-Investigator: Kara P Wiseman, PhD, MA
      • Sub-Investigator: Roger T Anderson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QuitAid + SmokefreeTXT + NRT (Patch + Lozenge); Participants will receive QuitAid, a medication therapy management delivered by their pharmacist, a texting intervention to help quit smoking, and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.	Behavioral: QuitAid; Participants will receive the QuitAid intervention, based on a medication adherence intervention, which addresses perceptions (e.g., motivation, self-efficacy, beliefs) and practicalities of using NRT (e.g., monitoring NRT use, establishing a reminder system). QuitAid includes 1 in-person session and 5 follow-up telephonic sessions with the participant's local pharmacist/technician. Smokers not ready to quit will receive up to two sessions focused on using NRT to cut down cigarette use. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the full QuitAid intervention.; Other Names: Medication Therapy Management (MTM); Behavioral: SmokefreeTXT; All participants will receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. For smokers not ready to quit, participants will receive two week-long pre-quit modules, Practice Quit and Daily Challenges. These modules will help the smoker become comfortable with not smoking for short periods of time and build skills before they attempt to quit. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the ready to quit treatment.; Drug: Nicotine Replacement Therapy Patch; All participants will receive up to 8 weeks of NRT in the form of patch. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.; Other Names: Habitrol Transdermal Product; Pixotine Transdermal Product; Lucy Transdermal Product; Nicoderm C-Q Transdermal Product; Nicotrol Transdermal Product; Drug: Nicotine lozenge; All participants will receive up to 8 weeks of NRT in the form of lozenge. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.; Other Names: Nicorette Lozenge; Sunmark Nicotine Polacrilex Lozenge; Habitrol Nicotine Lozenge; Nicotinell Nicotine Lozenge
Active Comparator: SmokefreeTXT + NRT (Patch + Lozenge); Participants will receive a texting intervention to help quit smoking and up to 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch + lozenge.	Behavioral: SmokefreeTXT; All participants will receive the SmokefreeTXT is a text-messaging program offered through the National Cancer Institute's Smokefree.gov initiative, which sends pre-programmed messages timed around a quit date. Participants will receive 3-5 messages a day for 7 weeks. The first week of messages focus on preparation and the remaining 6 weeks of messages focus on post-cessation strategies (e.g., relapse prevention), all timed relative to the quit date set at enrollment. For smokers not ready to quit, participants will receive two week-long pre-quit modules, Practice Quit and Daily Challenges. These modules will help the smoker become comfortable with not smoking for short periods of time and build skills before they attempt to quit. If a smoker decides they are ready to quit at the 2- or 4-week follow-ups, they will receive the ready to quit treatment.; Drug: Nicotine Replacement Therapy Patch; All participants will receive up to 8 weeks of NRT in the form of patch. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.; Other Names: Habitrol Transdermal Product; Pixotine Transdermal Product; Lucy Transdermal Product; Nicoderm C-Q Transdermal Product; Nicotrol Transdermal Product; Drug: Nicotine lozenge; All participants will receive up to 8 weeks of NRT in the form of lozenge. At the 4-week follow-up, all participants still smoking will be offered an additional 4 weeks of NRT, regardless of readiness to quit. NRT temporarily replaces nicotine from tobacco to reduce motivation to consume tobacco and nicotine withdrawal symptoms.; Other Names: Nicorette Lozenge; Sunmark Nicotine Polacrilex Lozenge; Habitrol Nicotine Lozenge; Nicotinell Nicotine Lozenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Recruitment	Measured by (a) the proportion of smokers recruited from each source (e.g., ask-advise-prescribe, posters, prescription bag advertisements) and (b) the number of smokers recruited per month.	6 months
Feasibility of Randomization	Determine the number of smokers that will needed to be approached and screened in order to randomize 100 smokers (e.g., ineligible smokers, smokers that do not consent) in six months across two FQHCs.	6 months
Feasibility of Retention	Assessment of the proportion of smokers who complete the 12-week follow-up.	12 weeks
Dose of the MTM intervention	Dose of the MTM intervention will be defined at the number of MTM sessions the participant received as documented in the REDCap database by the pharmacists.	12 weeks
Dose of the NRT	Dose of NRT will be defined as the percent of NRT used and will be collected from participants at the follow-ups.	12 weeks
Dose of SmokefreeTXT	Dose of SmokefreeTXT will be defined by the use of keywords, responses to the within-program assessment questions, and date of SmokefreeTXT opt out (i.e., texted "STOP", if applicable).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Verification of Tobacco Abstinence by Participants	The investigators will assess self-reported point prevalence abstinence defined as not smoking (even a puff) within the past seven days. If a participant reports no tobacco use in the previous 7-days at the at the 12-week follow-up point, we will ask them to go into their FQHC pharmacy where their pharmacist will biochemically verify their abstinence using Microport Smokelyzer carbon monoxide monitors within 48 hours. We will consider cutoff in the range of 3-4 ppm for carbon monoxide as viable cutoff to determine abstinence in their saliva to be smokers; this liberal definition will avoid false positives due to secondhand smoke. Lower results will indicate if smoking cessation treatment has been effective.	12 weeks
Quit Attempts	The number of times that participants have made a quit attempt since the previous contact at the 2-, 4-, 8- and 12-week follow-ups via electronic survey. A "quit attempt" will be defined as cigarette abstinence for ≥ 24 hours not due to involuntary or forced cessation (i.e., hospitalization). Lower results will indicate if smoking cessation treatment has been effective.	12 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Melissa A Little, PhD,MPH, University of Virginia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 9, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Smoking Cessation; Rural; Medicaid; Pharmacies; Appalachia; Pharmacists; Low Income; Federally Qualified Health Center; Readiness to Quit
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: HSR 230207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data Management System. This study will use REDCap electronic data capture tools hosted at the University of Virginia. The database will be hosted on secure, HIPAA-compliant UVA computing servers and its access will be restricted to authorized individuals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No