Interventions to Help More Low-income Smokers Quit

Study Overview
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Brief Summary
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In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes) to increase tobacco cessation.

Detailed Description
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There is an urgent need to engage more low-income smokers in activities that lead to quitting. The current standard of practice for population-level tobacco treatment is phone-based cessation counseling delivered by state tobacco quitlines. But quitline services are restricted to smokers who are ready to quit in the next 30 days, a criterion met by only 20-30% of low-income smokers. Thus, current population level tobacco treatment has nothing to offer 70-80% of low-income U.S. smokers. Based on extensive preliminary research by our study team, the investigators assert that offering a pre-cessation intervention - Smoke Free Homes - to low-income smokers who are not yet ready to quit will: (1) engage more smokers in using proven interventions; (2) increase their readiness to quit and quit attempts; (3) reduce the number of cigarettes they smoke per day; and (4) increase cessation. These benefits will accrue in addition to reducing exposure to harmful secondhand smoke for non-smokers in the home. In a Hybrid Type 2 randomized trial, 1,980 low-income smokers from nine states with high smoking prevalence will be recruited from 2-1-1 helplines to receive either current standard practice (Quitline) or expanded services (Quitline + Smoke Free Homes). In the latter condition, smokers will be offered cessation counseling first, just like current standard practice, but those who decline will then be offered Smoke Free Homes. At 3-month followup, those in the latter condition who accepted quitline services but did not quit will be offered Smoke Free Homes, and those that accepted Smoke Free Homes but did not quit will be offered quitline services. The effectiveness portion of the Hybrid Type 2 design (Aim 1) will use intent-to-treat analyses to compare group differences at 3- and 6-month follow-up in 7- and 30-day point prevalence abstinence with biochemical verification, as well as 24-hour quit attempts and cigarettes smoked per day. The implementation portion of the Hybrid Type 2 design (Aims 2-3) will measure smokers' acceptance and use of the interventions, as well as cost-effectiveness and cost-benefits of adding Smoke Free Homes to quitline services. With rates of smoking and smoking-related cancers much higher in low-income populations and treatment costs exceeding tens of billions of dollars annually in Medicaid alone, this large-scale practical trial will provide strong evidence with high external validity to answer an important policy question: Will changing the standard practice for population-level treatment of smoking result in increased cessation in low-income populations?

Official Title
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Expanding Population-level Interventions to Help More Low-income Smokers Quit

Conditions
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Tobacco Use Cessation, Smoking Behaviors, Health Disparity

Intervention / Treatment
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* Behavioral: Tobacco Quitline
* Behavioral: Smoke Free Home


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥21 English-speaking Daily smoker Does not have a full home smoking ban Recruited from those who called 2-1-1 for themselves and are not in acute crisis Exclusion Criteria: -Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two group intervention; standard care vs. standard + additional service
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tobacco Quitline only<br>Smokers in this study group will be offered their state Tobacco Quitline programs | Behavioral: Tobacco Quitline<br>* Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline (fax-back).<br>|
| Experimental: Tobacco Quitline plus Smoke Free Homes<br>Smokers in this study group will be offered their state Tobacco Quitline programs, but if they decline, they will be offered a Smoke Free Homes intervention | Behavioral: Tobacco Quitline<br>* Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline (fax-back).<br>Behavioral: Smoke Free Home<br>* The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7day point prevalence for smoking | Proportion of participants who have 7 day smoking abstinence | 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who accept the tobacco quitline program | All participants are asked at baseline if they are interested in trying the <STATE> tobacco quitline. Some participants are asked this question again at the 3-month follow-up The probability is the proportion who answer yes. | Baseline and 3-month follow-up |