Interventions to Help More Low-income Smokers Quit

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1973 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2023-09-29

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.

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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?

Conditions

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Tobacco Use Cessation Smoking Behaviors Health Disparity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two group intervention; standard care vs. standard + additional service

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm

Study Groups

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Tobacco Quitline only

Smokers in this study group will be offered their state Tobacco Quitline programs

Group Type ACTIVE_COMPARATOR

Tobacco Quitline

Intervention Type BEHAVIORAL

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").

Tobacco Quitline plus Smoke Free Homes

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

Group Type EXPERIMENTAL

Tobacco Quitline

Intervention Type BEHAVIORAL

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").

Smoke Free Home

Intervention Type BEHAVIORAL

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.

Interventions

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Tobacco Quitline

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").

Intervention Type BEHAVIORAL

Smoke Free Home

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.

Intervention Type BEHAVIORAL

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