Clinical trial NCT04547686: Efficacy of a Smoke-Free Homes Intervention
Official title: Randomized Controlled Trial to Test the Efficacy of a Smoke-Free Homes Intervention in Promoting Cessation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cessation, Smoking
Keywords: Smoke-Free
Home Intervention
Cessation
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2020-09-14
Enrollment: 918
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants who achieved smoking cessation/abstinence
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants self-reported 30-day abstinence at six-month follow-up
timeFrame: 6 months
measure: Number of participants self-reported 30-day abstinence at 12-month follow-up
timeFrame: 12 months
measure: Change in number of cigarettes smoked per day on smoking days
timeFrame: 6 months,12 months
measure: Number of quit attempts at 6-month follow up
timeFrame: 6 months
measure: Number of quit attempts at 12-month follow up
timeFrame: 12 months
measure: Number of participants that established smoke-free home and vehicle rules
timeFrame: 12 months
measure: Change in number of cigarettes smoked in the home
timeFrame: 6 months,12 months
measure: Duration of abstinence (i.e. days since last use) at 6-month follow up
timeFrame: 6 months
measure: Duration of abstinence (i.e. days since last use) at 12-month follow up
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Rollins School of Public Health, Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Michelle Kegler, DrPH
role: PRINCIPAL_INVESTIGATOR
References: