Medical University of South Carolina, Charleston, SC, USA.
University of Virginia, Department of Public Health Sciences, Charlottesville, VA, USA.
Contemp Clin Trials. 2023 Nov;134:107335. doi: 10.1016/j.cct.2023.107335. Epub 2023 Sep 18.
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 2 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.
NCT05660525.
与美国其他地区不同，农村阿巴拉契亚地区的吸烟率仍然停滞不前。利用社区药剂师为农村居民提供基于证据的戒烟治疗可能是一种途径。本文描述了一项混合方法研究的设计、原理和分析计划，该研究旨在确定可以在农村阿巴拉契亚地区的社区药房中整合的戒烟治疗成分组合。目的是通过因子实验量化五种高度可传播和可持续的戒烟成分的单独和协同作用。
这项基于 RE-AIM（可达性、有效性、采用、实施和维持）框架的顺序混合方法研究设计，将使用一项随机对照试验和 2 个完全交叉因子设计（32 种治疗组合），单独和组合测试最有效的基于证据的戒烟成分：（1）QuitAid（是/否）（2）烟草戒烟热线（是/否）（3）SmokefreeTXT（是/否）（4）联合 NRT 含片+NRT 贴剂（与 NRT 贴剂单独使用相比），以及（5）八周 NRT（与标准四周 NRT 相比）。
逻辑回归将对六个月时的戒烟情况进行建模，包括五个治疗因素的指标和治疗因素之间的所有双向交互作用。将考虑人口统计学和吸烟史变量，以评估潜在的效应修饰。泊松回归将对戒烟尝试和治疗成分的依从性百分比进行建模，作为次要结果。
这项研究将为如何利用医疗服务不足的农村地区的社区药房来增加对现有基于证据的烟草戒断资源的利用提供基础证据，以治疗烟草依赖。
NCT05660525。
