Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161675
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-09-08
Brief Title:
Feasibility of Delivering VergeRx at FQHCs
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Determining the Feasibility of Delivering VergeRx to Smokers Through Pharmacies in Federally Qualified Health Centers Regardless of Readiness to Quit
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cigarette smoking in the US 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 US 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 435 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None