Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment

Reaching adults who smoke cigarettes in rural Appalachia: Rationale, design & analysis plan for a mixed-methods study disseminating pharmacy-delivered cessation treatment

Unlike other U.S. geographical regions, cigarette smoking prevalence remains stagnant in rural Appalachia. One avenue for reaching rural residents with evidence-based smoking cessation treatments could be utilizing community pharmacists. This paper describes the design, rationale, and analysis plan...

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Bibliographic Details
Published in:Contemporary clinical trials Vol. 134; p. 107335
Main Authors: Fahey, M.C., Krukowski, R.A., Anderson, R.T., Cohn, W.F., Porter, K.J., Reid, T., Wiseman, K.P., You, W., Wood, C.H., Rucker, T.W., Little, M.A.
Format: Journal Article
Language:English
Published: United States Elsevier Inc 01-11-2023
Subjects:
Adult
Appalachia
Cigarette Smoking
factorial design
Humans
Nicotine - therapeutic use
Pharmacy
randomized clinical trial
rural health
Smoking Cessation - methods
tobacco cessation
Tobacco Use Cessation Devices
pharmacy
factorial design
randomized clinical trial
tobacco cessation
Appalachia
rural health
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Summary:Unlike other U.S. geographical regions, cigarette smoking prevalence remains stagnant in rural Appalachia. One avenue for reaching rural residents with evidence-based smoking cessation treatments could be utilizing community pharmacists. This paper describes the design, rationale, and analysis plan for a mixed-method study that will determine combinations of cessation treatment components that can be integrated within community pharmacies in rural Appalachia. The aim is to quantify the individual and synergistic effects of five highly disseminable and sustainable cessation components in a factorial experiment. This sequential, mixed-method research design, based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework, will use a randomized controlled trial with a 25 fully crossed factorial design (32 treatment combinations) to test, alone and in combination, the most effective evidence-based cessation components: (1) QuitAid (yes vs. no) (2) tobacco quit line (yes vs. no) (3) SmokefreeTXT (yes vs. no) (4) combination NRT lozenge + NRT patch (vs. NRT patch alone), and (5) eight weeks of NRT (vs. standard four weeks). Logistic regression will model abstinence at six-months, including indicators for the five treatment factors and all two-way interactions between the treatment factors. Demographic and smoking history variables will be considered to assess potential effect modification. Poisson regression will model quit attempts and percent of adherence to treatment components as secondary outcomes. This study will provide foundational evidence on how community pharmacies in medically underserved, rural regions can be leveraged to increase utilization of existing evidence-based tobacco cessation resources for treating tobacco dependence. Clinical Trials:NCT05660525
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
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content type line 23
ISSN:1551-7144
1559-2030
1559-2030
DOI:10.1016/j.cct.2023.107335