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
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov: NCT01123967.
VA HSR&D Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, 1 Veterans Drive (152), Minneapolis, MN 55417, USA. Steven.Fu@va.gov.
Steven S
SS
Fu
Michelle
M
van Ryn
Diana J
DJ
Burgess
David
D
Nelson
Barbara
B
Clothier
Janet L
JL
Thomas
John A
JA
Nyman
Anne M
AM
Joseph
D000293:Adolescent; D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods; D003376:Counseling / Q000191:economics / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D054625:Healthcare Disparities; D006801:Humans; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D010342:Patient Acceptance of Health Care; D011203:Poverty / Q000191:economics*; D011446:Prospective Studies; D016540:Smoking Cessation / Q000191:economics* / Q000379:methods* / Q000706:statistics & numerical data; D013689:Telephone; D061485:Tobacco Use Cessation Devices / Q000191:economics* / Q000706:statistics & numerical data; D014029:Tobacco Use Disorder / Q000191:economics / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult