Wealth and the utilization of long-term care services: evidence from the United States.

Long-term care (LTC) provision and financing has become a major challenge for policymakers in the United States and worldwide. To inform associated policies and more efficiently allocate LTC resources, it is important to understand how demand for different types of LTC services responds to increased wealth. We use data from the United States Health and Retirement Study to examine the use of LTC services following plausibly exogenous positive shocks to wealth. We further account for time-invariant household-level characteristics, including the expectation of a wealth shock at an unknown future time, by employing household fixed effects. We find that large positive wealth shocks lead to a greater probability of purchase of paid home care but not of nursing home care. Our results imply that expanding home and community-based services and insurance coverage of home care for people without sufficient wealth is likely to be efficient and welfare improving and should be considered by policymakers.Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 4 Given name: [R. Tamara] Last name: [Konetzka]. Also, kindly confirm the details in the metadata are correct.confirmedPlease confirm the city are correct and amend if necessary in Affiliations 1, 2, 3, 4.confirmed.

Mobile Health Intervention to Close the Guidelines-To-Practice Gap in Hypertension Treatment: Protocol for the mGlide Randomized Controlled Trial.

BACKGROUND: Suboptimal treatment of hypertension remains a widespread problem, particularly among minorities and socioeconomically disadvantaged groups. We present a health system-based intervention with diverse patient populations using readily available smartphone technology. This intervention is designed to empower patients and create partnerships between patients and their provider team to promote hypertension control. OBJECTIVE: The mGlide randomized controlled trial is a National Institutes of Health-funded study, evaluating whether a mobile health (mHealth)-based intervention that is an active partnership between interprofessional health care teams and patients results in better hypertension control rates than a state-of-clinical care comparison. METHODS: We are recruiting 450 participants including stroke survivors and primary care patients with elevated cardiovascular disease risk from diverse health systems. These systems include an acute stroke service (n=100), an academic medical center (n=150), and community medical centers including Federally Qualified Health Centers serving low-income and minority (Latino, Hmong, African American, Somali) patients (n=200). The primary aim tests the clinical effectiveness of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained hypertension control rates at 12 months; describe provider experiences of system usability and satisfaction; examine patient experiences, including medication adherence and medication use self-efficacy, self-rated health and quality of life, and adverse event rates; and complete a cost-effectiveness analysis. RESULTS: To date, we have randomized 107 participants (54 intervention, 53 control). CONCLUSIONS: This study will provide evidence for whether a readily available mHealth care model is better than state-of-clinical care for bridging the guideline-to-practice gap in hypertension treatment in health systems serving diverse patient populations. TRIAL REGISTRATION: Clinicaltrials.gov NCT03612271; https://clinicaltrials.gov/ct2/show/NCT03612271. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25424.

Cost of Medicare for All: Review of the Estimates.

This paper critically evaluates the estimates of the cost of Medicare for All (M4A) in the USA. Six studies that estimate the 1-year total cost of M4A in the USA are reviewed. These studies find that M4A would increase national health spending by as much as 16.9% or decrease it by 20.0%, representing a range of estimates that generates uncertainty and confusion regarding what to expect if M4A were implemented. To develop more comparable estimates, the national health spending in each study's comparison year is used as the baseline. Estimates of the change in national health spending under M4A for each report are broken down into five important components of costs and the percentage change from baseline is calculated. The assumptions regarding these cost components are evaluated for each study, and errors and inconsistencies identified. Using data from the literature and findings that are consistent across the reports where they exist, errors and inconsistencies are corrected, and new estimates of the cost components and the overall change in national health spending are calculated. After eliminating one of the reports as having methods that are too opaque to adjust and being an implausible outlier, and adjusting the findings of the remaining five reports, this paper finds that M4A would generate savings from 2.0 to 5.1% of baseline national health spending, averaging 3.9%. M4A would cost about 4% less than current national health spending, and eliminate the uninsured, expand coverage, and likely improve the health of Americans.

Cost-effectiveness of the Collaborative Care to Preserve Performance in Cancer (COPE) trial tele-rehabilitation interventions for patients with advanced cancers.

PURPOSE: The purpose of this analysis was to determine the cost-effectiveness of a Collaborative Care Model (CCM)-based, centralized telecare approach to delivering rehabilitation services to late-stage cancer patients experiencing functional limitations. METHODS: Data for this analysis came from the Collaborative Care to Preserve Performance in Cancer (COPE) trial, a randomized control trial of 516 patients assigned to: (a) a control group (arm A), (b) tele-rehabilitation (arm B), and (c) tele-rehabilitation plus pharmacological pain management (arm C). Patient quality of life was measured using the EQ-5D-3L at baseline, 3-month, and 6-month follow-up. Direct intervention costs were measured from the experience of the trial. Participants' hospitalization data were obtained from their medical records, and costs associated with these encounters were estimated from unit cost data and hospital-associated utilization information found in the literature. A secondary analysis of total utilization costs was conducted for the subset of COPE trial patients for whom comprehensive cost capture was possible. RESULTS: In the intervention-only model, tele-rehabilitation (arm B) was found to be the dominant strategy, with an incremental cost-effectiveness ratio (ICER) of $15 494/QALY. At the $100 000 willingness-to-pay threshold, this tele-rehabilitation was the cost-effective strategy in 95.4% of simulations. It was found to be cost saving compared to enhanced usual care once the downstream hospitalization costs were taken into account. In the total cost analysis, total inpatient hospitalization costs were significantly lower in both tele-rehabilitation (arm B) and tele-rehabilitation plus pain management (arm C) compared to control (arm A), (P = .048). CONCLUSION: The delivery of a CCM-based, centralized tele-rehabilitation intervention to patients with advanced stage cancer is highly cost-effective. Clinicians and care teams working with this vulnerable population should consider incorporating such interventions into their patient care plans.

Cost-effectiveness of population-level proactive tobacco cessation outreach among socio-economically disadvantaged smokers: evaluation of a randomized control trial.

AIMS: To estimate the cost-effectiveness at population-level of the OPT-IN proactive tobacco cessation outreach program for adult smokers enrolled in publicly funded health insurance plans for low-income persons (e.g. Medicaid). DESIGN: Cost-effectiveness analysis using a state transition model based on data from the Offering Proactive Treatment Intervention (OPT-IN) randomized control trial. SETTING: The trial was conducted in Minnesota, USA, and the economic analysis was conducted from the Medicaid program perspective. PARTICIPANTS: Data were used from 2406 smokers who were randomized into the intervention or comparator groups. INTERVENTION AND COMPARATOR: The intervention was comprised of proactive outreach (mailed invitation and telephone calls) and free cessation treatment (nicotine replacement therapy and intensive telephone counseling). The comparator was usual care, which comprised access to a primary care physician, insurance coverage of Food and Drug Administration (FDA)-approved smoking cessation medications and the state's telephone quitline. MEASUREMENTS: Smoking status, quality of life and health-care use at varying times, including at baseline and 1 year. FINDINGS: The OPT-IN program cost an average of $84 per participant greater than the comparator. One year after randomization, the population-level, 6-month prolonged smoking abstinence rate was 16.5% in the proactive outreach intervention group and 12.1% in the usual care group (P < 0.05). The model projected that the proactive outreach intervention added $78 in life-time cost and generated 0.005 additional quality-adjusted life-years (QALYs), with an expected incremental cost-effectiveness ratio of $4231 per QALY. Probabilistic sensitivity analysis found that the proactive outreach intervention would be cost-effective against a willingness-to-pay threshold of $50 000/QALY approximately 68% of the time. CONCLUSIONS: Population-level proactive tobacco treatment with personal telephone outreach was effective in achieving higher population-level quit rates and was cost-effective at various willingness-to-pay thresholds, compared with usual care (i.e. reactive treatment). Taken together with prior research, population-level proactive tobacco cessation outreach programs are judged to be highly cost-effective over the long term.

Cost-effectiveness of spinal manipulation, exercise, and self-management for spinal pain using an individual participant data meta-analysis approach: a study protocol.

Background: Spinal pain is a common and disabling condition with considerable socioeconomic burden. Spine pain management in the United States has gathered increased scrutiny amidst concerns of overutilization of costly and potentially harmful interventions and diagnostic tests. Conservative interventions such as spinal manipulation, exercise and self-management may provide value for the care of spinal pain, but little is known regarding the cost-effectiveness of these interventions in the U.S. Our primary objective for this project is to estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management for spinal pain using an individual patient data meta-analysis approach. Methods/design: We will estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management using cost and clinical outcome data collected in eight randomized clinical trials performed in the U.S. Cost-effectiveness will be assessed from both societal and healthcare perspectives using QALYs, pain intensity, and disability as effectiveness measures. The eight randomized clinical trials used similar methods and included different combinations of spinal manipulation, exercise therapy, or self-management for spinal pain. They also collected similar clinical outcome, healthcare utilization, and work productivity data. A two-stage approach to individual patient data meta-analysis will be conducted. Discussion: This project capitalizes on a unique opportunity to combine clinical and economic data collected in a several clinical trials that used similar methods. The findings will provide important information on the value of spinal manipulation, exercise therapy, and self-management for spinal pain management in the U.S.

Cost Recommendations in the Second Edition of Cost-Effectiveness in Health and Medicine: A Review.

A 2nd edition of Cost-Effectiveness in Health and Medicine has now been published by a group of medical decision-making experts known collectively as the 2nd Panel. This is a critical review of the recommendations for how to deal with costs in cost-effectiveness analysis, recommendations that are contained in Chapter 8 of that edition, titled "Estimating Costs and Valuations of Non-Health Benefits in Cost-Effectiveness Analysis," authored primarily but not exclusively by Anirban Basu. This review focuses on the correspondence between the costs in the numerator of the incremental cost-effectiveness ratio (ICER) and what is measured in the denominator of the ICER by the quality-adjusted life years (QALYs). Although it raises a number of issues regarding what is actually being measured in the numerator and denominator of the ICER, it primarily challenges the 2nd Panel's recommendation that the costs of non-health consumption in any additional years of life generated by the intervention in question be accounted for in the numerator, even though no measures of the benefits are included in the QALYs in the denominator. This review is adapted from a review of the entire 2nd edition that was sent to the 2nd Panel steering committee on January 8, 2016.

Using Cerebrospinal Fluid Biomarker Testing to Target Treatment to Patients with Mild Cognitive Impairment: A Cost-Effectiveness Analysis.

OBJECTIVE: Cerebrospinal fluid (CSF) biomarkers are shown to facilitate a risk identification of patients with mild cognitive impairment (MCI) into different risk levels of progression to Alzheimer's disease (AD). Knowing a patient's risk level provides an opportunity for earlier interventions, which could result in potential greater benefits. We assessed the cost effectiveness of the use of CSF biomarkers in MCI patients where the treatment decision was based on patients' risk level. METHODS: We developed a state-transition model to project lifetime quality-adjusted life-years (QALYs) and costs for a cohort of 65-year-old MCI patients from a US societal perspective. We compared four test-and-treat strategies where the decision to treat was based on a patient's risk level (low, intermediate, high) of progressing to AD with two strategies without testing, one where no patients were treated during the MCI phase and in the other all patients were treated. We performed deterministic and probabilistic sensitivity analyses to evaluate parameter uncertainty. RESULTS: Testing and treating low-risk MCI patients was the most cost-effective strategy with an incremental cost-effectiveness ratio (ICER) of US$37,700 per QALY. Our results were most sensitive to the level of treatment effectiveness for patients with mild AD and for MCI patients. Moreover, the ICERs for this strategy at the 2.5th and 97.5th percentiles were US$18,900 and US$50,100 per QALY, respectively. CONCLUSION: Based on the best available evidence regarding the treatment effectiveness for MCI, this study suggests the potential value of performing CSF biomarker testing for early targeted treatments among MCI patients with a narrow range for the ICER.

Cost-effectiveness of enhancing a Quit-and-Win smoking cessation program for college students.

OBJECTIVES: We conducted a cost-effectiveness analysis and model-based cost-utility and cost-benefit analysis of increased dosage (3 vs. 1 consecutive contests) and enhanced content (supplemental smoking-cessation counseling) of the Quit-and-Win contest using data from a randomized control trial enrolling college students in the US. METHODS: For the cost-utility and cost-benefit analyses, we used a microsimulation model of the life course of current and former smokers to translate the distribution of the duration of continuous abstinence among each treatment arm's participants observed at the end of the trial (N = 1217) into expected quality-adjusted life-years (QALYs) and costs and an incremental net monetary benefit (INMB). Missing observations in the trial were classified as smoking. For our reference case, we took a societal perspective and used a 3% discount rate for costs and benefits. A probabilistic sensitivity analysis (PSA) was performed to account for model and trial-estimated parameter uncertainty. We also conducted a cost-effectiveness analysis (cost per additional intermediate cessation) using direct costs of the intervention and two trial-based estimates of intermediate cessation: (a) biochemically verified (BV) 6-month continuous abstinence and (b) BV 30-day point prevalence abstinence at 6 months. RESULTS: Multiple contests resulted in a significantly higher BV 6-month continuous abstinence rate (RD 0.04), at a cost of $1275 per additional quit, and increased the duration of continuous abstinence among quitters. In the long run, multiple contests lead to an average gain of 0.03 QALYs and were cost saving. Incorporating parameter uncertainty into the analyses, the expected INMB was greater than $1000 for any realistic willingness to pay (WTP) for a QALY. CONCLUSIONS: Assuming missing values were smoking, multiple contests appear to dominate a single contest from a societal perspective. Funding agencies seeking to promote population health by funding a Quit-and-Win contest in a university setting should strongly consider offering multiple consecutive contests. Further research is needed to evaluate multiple contests compared to no contest.

A multicenter study of total pancreatectomy with islet autotransplantation (TPIAT): POST (Prospective Observational Study of TPIAT).

BACKGROUND/OBJECTIVES: Total pancreatectomy with islet autotransplantation (TPIAT) is considered for managing chronic pancreatitis in selected patients when medical and endoscopic interventions have not provided adequate relief from debilitating pain. Although more centers are performing TPIAT, we lack large, multi-center studies to guide decisions about selecting candidates for and timing of TPIAT. METHODS: Multiple centers across the United States (9 to date) performing TPIAT are prospectively enrolling patients undergoing TPIAT for chronic pancreatitis into the Prospective Observational Study of TPIAT (POST), a NIDDK funded study with a goal of accruing 450 TPIAT recipients. Baseline data include participant phenotype, pancreatitis history, and medical/psychological comorbidities from medical records, participant interview, and participant self-report (Medical Outcomes Survey Short Form-12, EQ-5D, andPROMIS inventories for pain interference, depression, and anxiety). Outcome measures are collected to at least 1 year after TPIAT, including the same participant questionnaires, visual analog pain scale, pain interference scores, opioid requirements, insulin requirements, islet graft function, and hemoglobin A1c. Health resource utilization data are collected for a cost-effectiveness analysis. Biorepository specimens including urine, serum/plasma, genetic material (saliva and blood), and pancreas tissue are collected for future study. CONCLUSIONS: This ongoing multicenter research study will enroll and follow TPIAT recipients, aiming to evaluate patient selection and timing for TPIAT to optimize pain relief, quality of life, and diabetes outcomes, and to measure the procedure's cost-effectiveness. A biorepository is also established for future ancillary studies.

Decomposition of moral hazard.

This study seeks to simulate the portion of moral hazard that is due to the income transfer contained in the coinsurance price reduction. Healthcare spending of uninsured individuals from the MEPS with a priority health condition is compared with the predicted counterfactual spending of those same individuals if they were insured with either (1) a conventional policy that paid off with a coinsurance rate or (2) a contingent claims policy that paid off by a lump sum payment upon becoming ill. The lump sum payment is set to be equal to the insurer's predicted spending under the coinsurance policy. The proportion of moral hazard that is efficient is calculated as the proportion of total moral hazard that is generated by this lump sum payment. We find that the efficient proportion of moral hazard varies from disease to disease, but is the highest for those with diabetes and cancer.

Treatment barriers among younger and older socioeconomically disadvantaged smokers.

OBJECTIVES: Underutilization of smoking cessation treatments contributes to high rates of smoking in socioeconomically disadvantaged populations. Guided by a conceptual framework, the present study explored how healthcare provider factors, social environment characteristics, and cessation beliefs influence treatment utilization among low-income smokers and whether these associations vary by age. STUDY DESIGN: Analyses were conducted on baseline data from 2406 participants enrolled in a randomized controlled trial that evaluated the effectiveness of a proactive outreach cessation intervention among a sample of younger (18-34 years) and older (35-64 years) smokers enrolled in public healthcare assistance programs. METHODS: Multivariable logistic regression models predicted past year cessation treatment utilization (CTU) among younger and older smokers. Independent variables included measures of healthcare provider barriers, social environment characteristics, and cessation beliefs. RESULTS: Younger smokers were less likely to have CTU than older smokers (27.2% vs 36.2%; P <.001). In both groups, number of cigarettes per day, more problems accessing healthcare, receiving medication-related cessation advice, and readiness to quit were positively associated with CTU (P <.05). Among younger smokers, living with another smoker was associated with lower odds of CTU while receipt of cessation advice was associated (P = .033) with higher odds of CTU. CONCLUSIONS: In this sample of low-income smokers, interest in quitting was high but treatment utilization was low. Increasing utilization of cessation treatments via interventions that target issues specific to low-income smokers, including healthcare provider access and advice, the home environment, and motivation to quit, is an important step toward reducing smoking rates in this population.

Effect of Workplace Weight Management on Health Care Expenditures and Quality of Life.

OBJECTIVE: We examined the effectiveness of the weight management program used by the University of Minnesota in reducing health care expenditures and improving quality of life of its employees, and also in reducing their absenteeism during a 3-year intervention. METHODS: A differences-in-differences regression approach was used to estimate the effect of weight management participation. We further applied ordinary least squares regression models with fixed effects to estimate the effect in an alternative analysis. RESULTS: Participation in the weight management program significantly reduced health care expenditures by $69 per month for employees, spouses, and dependents, and by $73 for employees only. Quality-of-life weights were 0.0045 points higher for participating employees than for nonparticipating ones. No significant effect was found for absenteeism. CONCLUSIONS: The workplace weight management used by the University of Minnesota reduced health care expenditures and improved quality of life.

The Economic Impact for Farm Injury in Minnesota, 2004-2010.

Only 2% of Minnesota's employed population worked in agriculture between the years 2005 and 2012. However, this small portion of the state's employed population accounted for 31% of total work-related deaths in the state during that same time period. During a similar time period, 2007-2013, the contribution of agriculture to Minnesota's gross domestic product increased from approximately 1.5% to about 2.3%. This article describes the economic impact of injuries related to farm work between the years 2004 and 2010. Using hospital discharge data and the Census of Fatal Occupational Injuries (CFOI), estimates of the number of injuries and fatalities related to agricultural work were compiled. A cost of illness model was applied to these injury and fatality estimates to calculate the related indirect and direct costs in 2010 dollars. Estimated total costs, in 2010 dollars, ranged between $21 and $31 million annually over the 7-year study period. The majority of the costs were attributable to indirect costs, such as lost productivity at work and home. Fatal injuries accrued the largest proportion of the estimated costs followed by hospitalized and nonhospitalized injuries. A sensitivity analysis was performed to evaluate the impact each selected data source had upon the cost estimate. The magnitude of the costs associated with these injuries argues for better surveillance of injury related to agriculture to prioritize resources and evaluate intervention and prevention programs.

Affordability of the Health Expenditures of Insured Americans Before the Affordable Care Act.

Central to the Affordable Care Act is the notion of affordability and the role of health insurance in making otherwise unaffordable health care affordable. We used data from the 1996 to 2008 versions of the Medical Expenditure Panel Survey to estimate the portion of overall health care expenditures by insured respondents that would otherwise have been beyond their disposable incomes and assets. We found that about one third of insured expenditures would have been unaffordable, with a much higher percentage among publicly insured individuals. This result suggests that one of the main functions of insurance is to cover expenses that insured individuals would not otherwise be able to afford.

For what illnesses is a disease management program most effective?

OBJECTIVE: We examined the impact of a disease management (DM) program offered at the University of Minnesota for those with various chronic diseases. METHODS: Differences-in-differences regression equations were estimated to determine the effect of DM participation by chronic condition on expenditures, absenteeism, hospitalizations, and avoidable hospitalizations. RESULTS: Disease management reduced health care expenditures for individuals with asthma, cardiovascular disease, congestive heart failure, depression, musculoskeletal problems, low back pain, and migraines. Disease management reduced hospitalizations for those same conditions except for congestive heart failure and reduced avoidable hospitalizations for individuals with asthma, depression, and low back pain. Disease management did not have any effect for individuals with diabetes, arthritis, or osteoporosis, nor did DM have any effect on absenteeism. CONCLUSIONS: Employers should focus on those conditions that generate savings when purchasing DM programs. CLINICAL SIGNIFICANCE: This study suggests that the University of Minnesota's DM program reduces hospitalizations for individuals with asthma, cardiovascular disease, depression, musculoskeletal problems, low back pain, and migraines. The program also reduced avoidable hospitalizations for individuals with asthma, depression, and low back pain.

Associations between smoking behaviors and financial stress among low-income smokers.

OBJECTIVE: Many American households struggle to bring in sufficient income to meet basic needs related to nutrition, housing, and healthcare. Nicotine addiction and consequent expenditures on cigarettes may impose extra financial strain on low-income households. We examine how cigarette use behaviors relate to self-reported financial stress/strain among low-income smokers. METHODS: At baseline in 2011/12, OPT-IN recruited adult smokers age 18-64 from the administrative databases of the state-subsidized Minnesota Health Care Programs (N = 2406). We tested whether nicotine dependency, type of cigarettes used, and smoking intensity were associated with self-reported difficulty affording food, healthcare, housing, and living within one's income. All regression models were adjusted for race, education, income, age, and gender. RESULTS: Difficulty living on one's income (77.4%), paying for healthcare (33.6%), paying for housing (38.4%), and paying for food (40.8%) were common conditions in this population. Time to first cigarette and cigarettes smoked per day predicted financial stress related to affording food, housing, and living within one's income (all p < 0.05). For instance, those whose time to first cigarette was greater than 60 minutes had about half the odds of reporting difficulty paying for housing compared to those who had their first cigarette within five minutes of waking (adjusted odds ratio = 0.55 [95% CI: 0.41, 0.73]). Type of cigarette used was not associated with any type of financial stress/strain. CONCLUSIONS: Smoking and particularly heavy smoking may contribute in an important way to the struggles that low-income households with smokers face in paying for necessities.

Cost effectiveness of telecare management for pain and depression in patients with cancer: results from a randomized trial.

OBJECTIVE: Pain and depression are prevalent and treatable symptoms among patients with cancer, yet they are often undetected and undertreated. The Indiana Cancer Pain and Depression (INCPAD) trial demonstrated that telecare management can improve pain and depression outcomes. This article investigates the incremental cost effectiveness of the INCPAD intervention. METHODS: The INCPAD trial was conducted in 16 community-based urban and rural oncology practices in Indiana. Of the 405 participants, 202 were randomized to the intervention group and 203 to the usual-care group. Intervention costs were determined, and effectiveness outcomes were depression-free days and quality-adjusted life years. RESULTS: The intervention group was associated with a yearly increase of 60.3 depression-free days (S.E. = 15.4; P < 0.01) and an increase of between 0.033 and 0.066 quality-adjusted life years compared to the usual care group. Total cost of the intervention per patient was US$1189, which included physician, nurse care manager and automated monitoring set-up and maintenance costs. Incremental cost per depression-free day was US$19.72, which yields a range of US$18,018 to US$36,035 per quality-adjusted life year when converted to that metric. When measured directly, the incremental cost per quality-adjusted life year ranged from US$10,826 based on the modified EQ-5D to US$73,286.92 based on the SF-12. CONCLUSION: Centralized telecare management, coupled with automated symptom monitoring, appears to be a cost effective intervention for managing pain and depression in cancer patients.

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

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.