Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial

BMC Public Health, Apr 2014

Background There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling. Methods/Design The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and 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 tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include 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 is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are 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. Discussion There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans. Clinical trials registration ClinicalTrials.gov: NCT01123967

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Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial

BMC Public Health Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial Steven S Fu 0 1 Michelle van Ryn 2 Diana J Burgess 0 1 David Nelson 0 1 Barbara Clothier 1 Janet L Thomas 0 John A Nyman 3 Anne M Joseph 0 0 Department of Medicine, University of Minnesota Medical School , Minneapolis, MN , USA 1 VA HSR&D Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System , 1 Veterans Drive (152), Minneapolis, MN 55417 , USA 2 Mayo Clinic, Division of Health Care Policy & Research , Rochester, MN , USA 3 Division of Health Policy and Management, University of Minnesota School of Public Health , Minneapolis, MN , USA Background: There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations. Effective, evidenced-based smoking cessation treatments are available, but low-income smokers are less likely than higher-income smokers to use these treatments, especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling. Methods/Design: The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers, and to determine the cost-effectiveness of proactive tobacco treatment intervention. The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and 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 tobacco cessation treatments in the form of NRT and intensive, telephone-based behavioral counseling. The study aims to include 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 is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization. Outcome data is collected from a follow-up survey conducted 12 months after randomization and MHCP administrative data. The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level. All randomized individuals are 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. Discussion: There is a critical need to increase access to effective tobacco dependence treatments. This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment. If proven to be effective and cost-effective, national dissemination of proactive treatment approaches would reduce tobacco-related morbidity, mortality, and health care costs for low income Americans. Clinical trials registration: ClinicalTrials.gov: NCT01123967 Smoking cessation; Health care disparities; Low-income population; Minority health - Background Tobacco use rates are alarmingly high in low-income populations. In the United States, 27.9% of adults living below the federal poverty level smoke cigarettes compared to 17% of adults at or above the poverty level [1]. About 34% of adult Medicaid enrollees currently smoke cigarettes, and racial/ethnic minorities and women are disproportionally represented in the Medicaid population [2]. Smoking rates in the uninsured population are similar to the Medicaid population and higher than the general population (32% compared to 16% for ages 1865) [2]. Smokers with lower incomes are also less likely to use evidence-based smoking cessation treatments such as pharmacotherapy and counseling than smokers with higher incomes [3-8]. In an analysis of the 2000 National Health Interview Survey, among smokers who were attempting to quit, only 15.5% of Medicaid enrollees used a cessation aid compared to 25.4% of individuals with private health insurance [6]. Consequently, low income populations experience an excess burden of tobacco-related morbidity and mortality. Additionally, this group can least afford the cost of cigarettes (an average of $2017 per year in the US) [9]. Over the past decade, coverage for tobacco dependence treatments by federal-state Medicaid programs has improved, but significant limitations remain. For example, the number of state Medicaid programs providing some coverage for tobacco dependence treatment increased from 25 in 1998 [10] to 47 in 2009 [11]. However, in 2009, only 18 state Medicaid programs covered individual cessation counseling for all of their enrollees. Most programs also require co-payments fo (...truncated)


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Steven S Fu, Michelle van Ryn, Diana J Burgess, David Nelson, Barbara Clothier, Janet L Thomas, John A Nyman, Anne M Joseph. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial, BMC Public Health, 2014, pp. 337, 14, DOI: 10.1186/1471-2458-14-337