Efficacy of a Smoke-Free Homes Intervention

Study Overview
=================
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.

Official Title
-----------------
Randomized Controlled Trial to Test the Efficacy of a Smoke-Free Homes Intervention in Promoting Cessation

Conditions
-----------------
Cessation, Smoking

Intervention / Treatment
-----------------
* Behavioral: Smoke-Free Homes Intervention
* Behavioral: Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoke-Free Homes Intervention<br>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. | Behavioral: Smoke-Free Homes Intervention<br>* The adapted smoke-free homes intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers. The intervention is based on principles of Social Cognitive Theory and the Transtheoretical Model's stages of change. The rationale underlying the intervention is that creation of additional smoke-free environments will reduce situational and environmental cues to smoke, reduce opportunities and places to smoke, increase self-efficacy for quitting and increase motivation to quit. The intervention uses persuasion, role modeling, behavioral contracting and goal setting to move smokers through behavioral capability, outcome expectations and self-efficacy for strict smoke-free rules, creation of and compliance/enforcement with smoke-free rules, reduced cigarettes smoked per day, increased motivation to quit, increased quit attempts, and successful cessation.<br>Behavioral: Control<br>* The quitline is a phone number that people can call that offers free smoking cessation counseling to all Georgia residents by the state of Georgia.<br>|
| Active Comparator: Control<br>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. | Behavioral: Control<br>* The quitline is a phone number that people can call that offers free smoking cessation counseling to all Georgia residents by the state of Georgia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who achieved smoking cessation/abstinence | Cotinine-validated 7-day point-prevalence abstinence at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants self-reported 30-day abstinence at six-month follow-up | Number of patients self-reported 30-day abstinence at six-month follow-up will be recorded | 6 months | 
| Number of participants self-reported 30-day abstinence at 12-month follow-up | Number of patients self-reported 30-day abstinence at 12-month follow-up will be recorded | 12 months | 
| Change in number of cigarettes smoked per day on smoking days | Number of cigarettes smoked per day on smoking days will be recorded | 6 months,12 months | 
| Number of quit attempts at 6-month follow up | Number of quit attempts will be recorded | 6 months | 
| Number of quit attempts at 12-month follow up | Number of quit attempts will be recorded | 12 months | 
| Number of participants that established smoke-free home and vehicle rules | Number of participants that established smoke-free home and vehicle rules will be recorded | 12 months | 
| Change in number of cigarettes smoked in the home | Number of cigarettes smoked in the home will be recorded | 6 months,12 months | 
| Duration of abstinence (i.e. days since last use) at 6-month follow up | Duration of abstinence (i.e. days since last use) will be self-reported | 6 months | 
| Duration of abstinence (i.e. days since last use) at 12-month follow up | Duration of abstinence (i.e. days since last use) will be self-reported | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smoke-Free, Home Intervention, Cessation