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.
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