BACKGROUND Tobacco use remains the leading cause of death and disability in the USA and is disproportionately concentrated among low socioeconomic status (SES) populations. Community Health Centers (CHCs) are a key venue for reaching low SES populations with evidence-based tobacco cessation treatment such as Quitlines. Electronic health record (EHR)-based interventions at the point-of-care, text messaging (TM), and phone counseling have the potential to increase Quitline reach and are feasible to implement within CHCs. However, there is a lack of data to inform how, when, and in what combination these strategies should be implemented. The aims of this cluster-randomized trial are to evaluate multi-level implementation strategies to increase the Reach (i.e., proportion of tobacco-using patients who enroll in the Quitline) and Impact (i.e., Reach × Efficacy [efficacy is defined as the proportion of tobacco-using patients who enroll in Quitline treatment that successfully quit]) and to evaluate characteristics of healthcare system, providers, and patients that may influence tobacco-use outcomes. METHODS This study is a multilevel, three-phase, Sequential Multiple Assignment Randomized Trial (SMART), conducted in CHCs (N = 33 clinics; N = 6000 patients). In the first phase, clinics will be randomized to two different EHR conditions. The second and third phases are patient-level randomizations based on prior treatment response. Patients who enroll in the Quitline receive no further interventions. In phase two, patients who are non-responders (i.e., patients who do not enroll in Quitline) will be randomized to receive either TM or continued-EHR. In phase three, patients in the TM condition who are non-responders will be randomized to receive either continued-TM or TM + phone coaching. DISCUSSION This project will evaluate scalable, multi-level interventions to directly address strategic national priorities for reducing tobacco use and related disparities by increasing the Reach and Impact of evidence-based tobacco cessation interventions in low SES populations. TRIAL REGISTRATION This trial was registered at ClinicalTrials.gov (NCT03900767) on April 4th, 2019.

中文翻译：

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QuitSMART 犹他州：一项整群随机、多层次序贯多重分配随机试验的实施研究方案，旨在扩大社区健康中心戒烟治疗的覆盖范围和影响。


背景技术烟草使用仍然是美国死亡和残疾的主要原因，并且不成比例地集中在低社会经济地位（SES）人群中。社区健康中心 (CHC) 是向低社会经济地位人群提供循证戒烟治疗（如戒烟热线）的关键场所。基于电子健康记录 (EHR) 的护理点干预、短信 (TM) 和电话咨询有可能扩大戒烟热线的覆盖范围，并且在社区卫生中心内实施是可行的。然而，缺乏数据来说明如何、何时以及以何种组合方式实施这些策略。这项整群随机试验的目的是评估多层次实施策略，以提高覆盖率（即参加戒烟热线的吸烟患者的比例）和影响力（即覆盖率 × 功效[功效定义为比例参加戒烟热线治疗并成功戒烟的吸烟患者]）并评估可能影响烟草使用结果的医疗保健系统、提供者和患者的特征。方法 本研究是一项多水平、三阶段、序贯多重分配随机试验 (SMART)，在 CHC 中进行（N = 33 家诊所；N = 6000 名患者）。在第一阶段，诊所将被随机分配到两种不同的 EHR 条件。第二和第三阶段是基于先前治疗反应的患者水平随机化。加入戒烟热线的患者不会接受进一步的干预。在第二阶段，无反应患者（即未加入戒烟热线的患者）将被随机分配接受 TM 或持续 EHR 治疗。 在第三阶段，处于 TM 状态且无反应的患者将被随机分配接受持续 TM 或 TM + 电话辅导。讨论 该项目将评估可扩展的多层次干预措施，通过增加低社会经济地位人群中基于证据的戒烟干预措施的范围和影响，直接解决减少烟草使用和相关差异的国家战略优先事项。试验注册 该试验于 2019 年 4 月 4 日在 ClinicalTrials.gov (NCT03900767) 上注册。