Tobacco Use Cessation, Smoking Behaviors, Health Disparity
Conditions
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?
Interventions
Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline (fax-back).
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.
Sponsors
Study design
Masking description
Participants are unaware of the arms and principal investigators are unaware of participant's randomization to study arm
Intervention model description
Two group intervention; standard care vs. standard + additional service
Eligibility
Inclusion criteria
* Age ≥21 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7day Point Prevalence for Smoking | 6 month follow-up | Percentage of participants who have 7 day smoking abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Accept the Tobacco Quitline Program | Baseline and 3-month follow-up | * All participants are asked at baseline if they are interested in trying the \<STATE\> tobacco quitline. Some participants are asked this question again at the 3-month follow-up * The probability is the proportion who answer yes. * Due to our study design, at 3-month follow-up, Tobacco Quitline plus Smoke Free Homes participants were only offered the Quitline if they had not chosen it at baseline. The proportion in the table is the number of participants who accepted the Quitline divided by number who were offered the Quitline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tobacco Quitline Only Smokers in this study group will be offered their state Tobacco Quitline programs | 987 |
| Tobacco Quitline Plus Smoke Free Homes 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 | 986 |
| Total | 1,973 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Incomplete survey | 7 | 9 |
| Overall Study | Lost to Follow-up | 421 | 456 |
Baseline characteristics
| Characteristic | Tobacco Quitline Plus Smoke Free Homes | Total | Tobacco Quitline Only |
|---|---|---|---|
| Age, Continuous | 51 years | 51 years | 51 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 52 Participants | 98 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 928 Participants | 1867 Participants | 939 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 17 Participants | 31 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian/Asian American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Black/African American | 406 Participants | 811 Participants | 405 Participants |
| Race/Ethnicity, Customized Multiracial | 52 Participants | 117 Participants | 65 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 27 Participants | 64 Participants | 37 Participants |
| Race/Ethnicity, Customized Unknown/Missing | 18 Participants | 25 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 463 Participants | 919 Participants | 456 Participants |
| Region of Enrollment United States | 986 participants | 1973 participants | 987 participants |
| Sex/Gender, Customized Female | 677 Participants | 1342 Participants | 665 Participants |
| Sex/Gender, Customized Male | 304 Participants | 621 Participants | 317 Participants |
| Sex/Gender, Customized Unknown | 5 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 987 | 0 / 986 |
| other Total, other adverse events | 0 / 987 | 0 / 986 |
| serious Total, serious adverse events | 0 / 987 | 0 / 986 |
Outcome results
7day Point Prevalence for Smoking
Percentage of participants who have 7 day smoking abstinence
Time frame: 6 month follow-up
Population: Participants were not included if they were lost to follow-up or were duplicate enrollees.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tobacco Quitline Only | 7day Point Prevalence for Smoking | 78 Participants |
| Tobacco Quitline Plus Smoke Free Homes | 7day Point Prevalence for Smoking | 83 Participants |
Proportion of Participants Who Accept the Tobacco Quitline Program
* All participants are asked at baseline if they are interested in trying the \<STATE\> tobacco quitline. Some participants are asked this question again at the 3-month follow-up * The probability is the proportion who answer yes. * Due to our study design, at 3-month follow-up, Tobacco Quitline plus Smoke Free Homes participants were only offered the Quitline if they had not chosen it at baseline. The proportion in the table is the number of participants who accepted the Quitline divided by number who were offered the Quitline.
Time frame: Baseline and 3-month follow-up
Population: At baseline, participants weren't included if they were duplicate entries. At 3-month follow-up, participants weren't included if they were duplicated entries or if they were lost to follow-up. Also, in Arm 2 at 3-month follow-up, if participants had chosen the quitline at baseline and did not quit, they were not re-offered the quitline; they were only offered Smoke-Free Homes. This was a planned part of the study design.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tobacco Quitline Only | Proportion of Participants Who Accept the Tobacco Quitline Program | Baseline | 592 Participants |
| Tobacco Quitline Only | Proportion of Participants Who Accept the Tobacco Quitline Program | 3-month follow-up | 385 Participants |
| Tobacco Quitline Plus Smoke Free Homes | Proportion of Participants Who Accept the Tobacco Quitline Program | Baseline | 587 Participants |
| Tobacco Quitline Plus Smoke Free Homes | Proportion of Participants Who Accept the Tobacco Quitline Program | 3-month follow-up | 142 Participants |