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临床试验/NCT06161675
NCT06161675进行中(未招募)不适用

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

University of Virginia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Feasibility of Randomization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The baseline, 2-, 4-, 8- and 12-week follow-ups will be administered telephonically by trained research assistants blinded to the participant's treatment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

Experimental

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.

干预措施: QuitAid (Behavioral)

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

Experimental

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.

干预措施: SmokefreeTXT (Behavioral)

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

Experimental

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.

干预措施: Nicotine Replacement Therapy Patch (Drug)

QuitAid + SmokefreeTXT + NRT (Patch + Lozenge)

Experimental

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.

干预措施: Nicotine lozenge (Drug)

SmokefreeTXT + NRT (Patch + Lozenge)

Active Comparator

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.

干预措施: SmokefreeTXT (Behavioral)

SmokefreeTXT + NRT (Patch + Lozenge)

Active Comparator

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.

干预措施: Nicotine Replacement Therapy Patch (Drug)

SmokefreeTXT + NRT (Patch + Lozenge)

Active Comparator

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.

干预措施: Nicotine lozenge (Drug)

结局指标

主要结局

Feasibility of Randomization

时间窗: 6 months

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.

Feasibility of Retention

时间窗: 12 weeks

Assessment of the proportion of smokers who complete the 12-week follow-up.

Dose of SmokefreeTXT

时间窗: 12 weeks

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).

Feasibility of Recruitment

时间窗: 6 months

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.

Dose of the MTM intervention

时间窗: 12 weeks

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.

Dose of the NRT

时间窗: 12 weeks

Dose of NRT will be defined as the percent of NRT used and will be collected from participants at the follow-ups.

次要结局

  • Biochemical Verification of Tobacco Abstinence by Participants(12 weeks)
  • Quit Attempts(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Little, PhD, MPH

Associate Professor, Department of Public Health Sciences Director, Center for Tobacco Prevention and Control Research

University of Virginia

研究点 (1)

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