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

Tobacco Use Cessation Clinical Trial

— SFH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427839
• Other study ID #: HRPO201912030
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, we 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1980
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• English-speaking adults 21 years and older who smoke daily, have no 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

Related Conditions & MeSH terms

• Health Disparity
• Smoking Behaviors
• Tobacco Use Cessation

Intervention

Behavioral:
• Tobacco Quitline
Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT, a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline ("fax-back").
• Smoke Free Homes
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.

Locations

Country	Name	City	State
United States	Health Communication Research Laboratory	Saint Louis	Missouri
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	7-day point prevalence abstinence	3 month follow up
Primary	Smoking Cessation	7-day point prevalence abstinence	6 month follow up
Secondary	Acceptance of tobacco quitline program	Cumulative probabilities of accepting quitline services during the study period by group	6 month follow up