Skip to main content
Clinical Trials/NCT04311983
NCT04311983CompletedNot Applicable

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

Washington University School of Medicine1 site in 1 country1,973 target enrollmentStarted: March 31, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,973
Locations
1
Primary Endpoint
7day Point Prevalence for Smoking

Study Overview

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?

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Tobacco Quitline only

Active Comparator

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

Intervention: Tobacco Quitline (Behavioral)

Tobacco Quitline plus Smoke Free Homes

Experimental

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

Intervention: Tobacco Quitline (Behavioral)

Tobacco Quitline plus Smoke Free Homes

Experimental

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

Intervention: Smoke Free Home (Behavioral)

Outcomes

Primary Outcomes

7day Point Prevalence for Smoking

Time Frame: 6 month follow-up

Percentage of participants who have 7 day smoking abstinence

Secondary Outcomes

  • Proportion of Participants Who Accept the Tobacco Quitline Program(Baseline and 3-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Interventions to Help More Low-income... | Clinical Trial