Effectiveness of Proactive Tobacco Treatment in Diverse Low Income Smokers

描述（由申请人提供）：在低收入人群中，吸烟流行率高，烟草相关疾病负担高。有效的、基于证据的戒烟治疗是可用的，但低收入和少数族裔吸烟者比高收入和白人吸烟者更不可能使用这些治疗，特别是包括药物治疗和强化行为咨询相结合的最全面的形式。在本应用中，我们测试了一种新的主动外展策略，结合免费尼古丁替代疗法（NRT），以增加戒烟治疗对不同低收入吸烟者的人群影响。人口影响是治疗利用（即覆盖面或接触）和治疗效果（即接受治疗者的戒烟率）的产物；因此，理论驱动的方法将系统地为低收入吸烟者提供免费和方便的传统卫生保健系统之外的烟草依赖循证治疗。该干预措施有两个主要组成部分：1)以邮寄邀请材料和包含目标健康信息的电话的形式主动向现有吸烟者伸出援手；2)以NRT和密集的电话行为咨询的形式促进获得免费、全面、基于证据的烟草依赖治疗。我们的具体目标是：1)比较主动外展结合免费NRT和电话咨询（PRO+NRT+TC）与常规护理（UC）对不同低收入吸烟者人群中人群水平戒烟率的影响，2)比较PRO+NRT+TC与常规护理UC对人群水平烟草治疗利用率的影响，3)确定PRO+NRT+TC的成本效益。该提案将在一个以人口为基础的样本（N=2500）中检验干预的效果，这些样本是参加明尼苏达州医疗保健计划（MHCP）的成年吸烟者，MHCP是一项由国家资助的低收入者健康保险计划。基线数据将从MHCP管理数据库和随机化前进行的参与者调查中获得。结果数据将从随机分组后12个月的随访调查和MHCP管理数据中收集。主要结果是长期戒烟（6个月），并将在人群水平上进行评估。所有随机抽取的个体将被要求完成随访调查，无论他们是否参与烟草治疗。主要目标的数据分析将遵循意向治疗方法。研究小组在不同低收入人群的烟草治疗研究、积极的外展和电话咨询方面具有独特的相关经验。我们将与北美戒烟热线协会合作，传播研究结果。如果有效，积极的烟草治疗将减少与烟草有关的发病率，死亡率和低收入美国人的医疗保健费用。

DESCRIPTION (provided by applicant): There is a high prevalence of smoking and high burden of tobacco related disease among low income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income and minority smokers are less likely than higher-income and white smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling. In this application, we test a novel proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment); therefore, the theory- driven approach will systematically offer low income smokers free and easy access to evidence-based treatment for tobacco dependence outside the traditional health care system. The intervention has two primary components: 1) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages, and 2) facilitated access to free, comprehensive, evidence-based treatment for tobacco dependence in the form of NRT and intensive, telephone-based behavioral counseling. Our specific aims are to: 1) compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers, 2) compare the effect of PRO+NRT+TC to usual care UC on population-level tobacco treatment utilization rates, and 3) determine the cost-effectiveness of PRO+NRT+TC. This proposal will examine the effects of the intervention in a population-based sample (N=2500) of adult smokers enrolled in the Minnesota Health Care Programs (MHCP), a state-funded health insurance plan for low income persons. Baseline data will be obtained from MHCP administrative databases and a participant survey that will be conducted prior to randomization. Outcome data will be collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is prolonged smoking abstinence (6 months) and will be assessed at the population level. All randomized individuals will be asked to complete the follow-up survey, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology. The study team has unique, relevant experience with tobacco treatment studies in diverse, low income populations, proactive outreach and telephone counseling. We will work in partnership with the North American Quitline Consortium to disseminate study findings. If effective, proactive tobacco treatment would reduce tobacco- related morbidity, mortality and health care costs for low income Americans.