Interventions to Help More Low-income Smokers Quit

Not Applicable

Completed

• Conditions: Smoking Behaviors; Tobacco Use Cessation; Health Disparity
• Interventions: Behavioral: Tobacco Quitline; Behavioral: Smoke Free Home

• Registration Number: NCT04311983
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-17
• Study Start: 2020-03-31
• Primary Completion: 2023-09-29
• Study Completion: 2023-09-29
• Results First Submitted: 2024-09-11
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Results First Posted: 2024-10-10
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1973

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

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Exclusion Criteria

-Pregnant women, because recommended tobacco cessation actions differ for this subset of smokers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobacco Quitline plus Smoke Free Homes	Smoke Free Home	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
Tobacco Quitline plus Smoke Free Homes	Tobacco Quitline	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
Tobacco Quitline only	Tobacco Quitline	Smokers in this study group will be offered their state Tobacco Quitline programs

Primary Outcome Measures

Name	Time	Method
7day Point Prevalence for Smoking	6 month follow-up	Percentage of participants who have 7 day smoking abstinence

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants Who Accept the Tobacco Quitline Program	Baseline and 3-month follow-up	* 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".; * Due to our study design, at 3-month follow-up, Tobacco Quitline plus Smoke Free Homes participants were only offered the Quitline if they had not chosen it at baseline. The proportion in the table is the number of participants who accepted the Quitline divided by number who were offered the Quitline.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States