Efficacy of a Smoke-Free Homes Intervention
- Conditions
- Cessation, Smoking
- Interventions
- Behavioral: Smoke-Free Homes InterventionBehavioral: Control
- Registration Number
- NCT04547686
- Lead Sponsor
- Emory University
- Brief Summary
The purpose of this study is to test whether the integration of a smoke-free homes intervention into the clinical guidelines for tobacco cessation can encourage sustained smoking cessation in low-income primary care patients. The intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers.
- Detailed Description
Tobacco use remains the top preventable cause of death and disease in the U.S., is a major cause of cancer and cardiovascular disease, and is responsible for 480,000 deaths per year. Recent prevalence estimates show that 15.1% of adults (36.5 million) smoke cigarettes, with significant disparities in rates by socio-economic status and race/ethnicity. Among those living below poverty, 26.1% smoked in 2015, in contrast to 13.9% living above the poverty threshold. Smoking rates are also higher among those on Medicaid (27.8%), uninsured persons (27.4%) and those living in rural areas, particularly in the South. Quitting smoking reduces premature mortality, and is beneficial to health across the lifespan. The majority (68.8%) of smokers would like to quit and over half try to quit in any given year. Unfortunately, of those who try to quit, a relatively small proportion succeed. Of significance to this study, just 7% to 20% plan to quit within the next 30 days.
Low-income populations, such as those served by a Federally Qualified Health Center (FQHC), are less likely to have a Smoke-Free Home (SFH). Nationally, in 2012-2013, among combustible-only tobacco users, 53.7% reported a SFH. Among those with an annual household income \<$20,000, just 37.0% had a SFH. It increased to 48.5% for smokers with an annual household income between $20,000 and $49,999, and 63% for those with annual household incomes between $50,000 and $100,000. Given that the majority of FQHC patients live in poverty, we anticipate that over 60% of FQHC patients who smoke will not yet have a SFH.
This study is a randomized controlled trial with smokers from Federally Qualified Health Centers (FQHCs) in Georgia which will compare the efficacy of adding a smoke-free homes intervention to the currently recommended clinical guidelines on tobacco cessation. Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline, if they are interested (the quitline is a free cessation counseling offered to all Georgia residents by the state of Georgia). The usual care/control arm will receive mailed information on the quitline immediately following the baseline interview and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 918
- 18 years of age and older
- referred by primary care physician or provider of a participating Federally Qualified Health Center (FQHC) in Georgia
- have smoked at least one cigarette in the past 30 days
- has ability to speak and understand English
- be the only patient per household to be enrolled in the study
- not currently be enrolled in a cessation program
-
non-smoker
-
unable to speak or understand English
-
under 18 years of age
-
have another family or household member participating in the research
-
vulnerable special populations will not be enrolled, including:
- adults unable to consent
- pregnant women
- prisoners
- cognitively impaired or Individuals with Impaired Decision-Making Capacity
- not able to clearly understand English
- community participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Smoke-Free Homes Intervention Smoke-Free Homes Intervention Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. Smoke-Free Homes Intervention Control Participants in the intervention condition will receive the expanded Smoke-Free Homes intervention coupled with a connection to the quitline. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation. Control Control The usual care/control arm will receive mailed information on the quitline and a connection to the quitline at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
- Primary Outcome Measures
Name Time Method Number of participants who achieved smoking cessation/abstinence 12 months Cotinine-validated 7-day point-prevalence abstinence at 12 months
- Secondary Outcome Measures
Name Time Method Number of quit attempts at 6-month follow up 6 months Number of quit attempts will be recorded
Number of participants self-reported 30-day abstinence at 12-month follow-up 12 months Number of patients self-reported 30-day abstinence at 12-month follow-up will be recorded
Number of quit attempts at 12-month follow up 12 months Number of quit attempts will be recorded
Change in number of cigarettes smoked in the home 6 months,12 months Number of cigarettes smoked in the home will be recorded
Duration of abstinence (i.e. days since last use) at 6-month follow up 6 months Duration of abstinence (i.e. days since last use) will be self-reported
Number of participants that established smoke-free home and vehicle rules 12 months Number of participants that established smoke-free home and vehicle rules will be recorded
Number of participants self-reported 30-day abstinence at six-month follow-up 6 months Number of patients self-reported 30-day abstinence at six-month follow-up will be recorded
Change in number of cigarettes smoked per day on smoking days 6 months,12 months Number of cigarettes smoked per day on smoking days will be recorded
Duration of abstinence (i.e. days since last use) at 12-month follow up 12 months Duration of abstinence (i.e. days since last use) will be self-reported
Trial Locations
- Locations (1)
Rollins School of Public Health, Emory University
🇺🇸Atlanta, Georgia, United States