Tobacco Use Cessation
Conditions
Keywords
Smoking, Smoking cessation, Quitline, Nicotine Replacement Therapy, SmokefreeTXT text messages, Financial incentives
Brief summary
This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. These strategies include: increasing the intensity of nicotine replacement medication (among those medically cleared to use such medications), increasing the intensity of WTQL counseling, helping callers enroll in an evidence-based smoking cessation texting support program (SmokefreeTXT), and offering moderate financial incentives for engagement in counseling and SmokefreeTXT.
Detailed description
This study seeks to evaluate ways to improve outcomes for low-education, uninsured or Medicaid-eligible smokers who do not successfully quit with standard telephone quit line treatment. The study will use an efficient factorial study design to evaluate four evidence-based strategies to improve follow-up care offered by the Wisconsin Tobacco Quit Line (WTQL) to socioeconomically disadvantaged callers who report smoking four months following initial WTQL treatment comprising a single counseling call and 2-week supply of a single nicotine replacement therapy. The four factors (strategies) to be studied include: (1) Quit line counseling intensity (1 vs 4 proactive calls); (2) Nicotine replacement therapy (NRT) intensity (Patch for 2 weeks vs Patch+Lozenge for 4 weeks); (3) SmokefreeTXT text messages (proactive enrollment vs none); and (4) financial incentives for treatment engagement (vs none). The study design is a fully-crossed 4-factor factorial design. The primary aim is: Assessment of the main and interactive effects of the four treatment factors on biochemically-confirmed 7-day point-prevalence abstinence at the 6-month followup. Secondary aims include testing: (1) self-reported abstinence at 12 weeks post-quit; (2) continuous abstinence between 1 and 6 months; (3) cost-effectiveness; and (4) moderators of treatment engagement and mediators of treatment effectiveness on 6-month abstinence.
Interventions
BEHAVIORAL1-Call Quitline Counseling
The 1-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 1 proactive call using a standard, evidence-based protocol lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.
BEHAVIORAL4-Call Quitline Counseling
The 4-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 4 proactive calls that use a standard, evidence-based protocol with each call lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.
DRUGNicotine patch
Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD).
DRUGNicotine Patch and Nicotine Lozenge
The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); the Nicotine Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking).
BEHAVIORALSmokefreeTXT
SmokefreeTXT support is a national program offered at no cost to users (apart from data/minute costs charged by cellular providers about which enrollees are advised at enrollment) and is sponsored by the National Cancer Institute. This program sends up to 5 messages per day for up to 2 weeks prior to the target quit day and 6 weeks following the target quit day (total duration may be longer if participants elect to change the target quit day). The text messages offer tips to help enrollees achieve their goal of quitting smoking and offer real-time interactive tips when participants text in responses indicating cravings, negative moods, or slips. Participants have the option to reset quit dates and have the option to unsubscribe at any time by texting STOP to the program.
BEHAVIORALNo SmokefreeTXT
Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
BEHAVIORALFinancial Incentives for Treatment Engagement
Incentives for treatment engagement are for each counseling session and for staying enrolled in SmokefreeTXT for six weeks. These incentives are designed to bolster motivation to stay engaged in treatment and to offset the costs and effort of treatment engagement (in terms of cell phone minutes).
BEHAVIORALNo Financial Incentives for Treatment Engagement
No Financial Incentives for Treatment Engagement are offered.
Sponsors
George Washington University
Consumer Wellness Solutions
National Cancer Institute (NCI)
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff who conduct follow-up interviews and verification will be blind to study condition and will not have access to other participant data (e.g., smoking history) prior to the end of data collection.
Intervention model description
Four-factor fully-crossed factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Uninsured, covered by BadgerCareWisconsin or another Medicaid program, or has no more than a high school education 2. Lives in Wisconsin 3. Age 18 or older 4. English speaking 5. Must provide a unique telephone number not already registered in the Wisconsin Tobacco Quit Line (WTQL) database for this study (to prevent duplicate enrollment and to ensure that only one person per household enrolls) 6. Must have completed standard WTQL treatment including at least one counseling call 2.5-18 months prior to study recruitment 7. Reported smoking at least 6 of the last 7 days at the WTQL follow-up enrollment call (2.5-18 months after completing standard WTQL treatment), with at least 5 cigarettes smoked on 1 or more days 8. Willing to set a new quit day within 2 weeks
Exclusion criteria
1\. Pregnancy, breastfeeding, or planning to become pregnant in the next 6 months at the time of study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Point-Prevalence Abstinence | 6-months | Participants will be coded as abstinent if they self-report no smoking for the past 7 days at the assessment endpoint (6 month follow-up) and provide a saliva sample for cotinine testing with a value of \<4 ng/ml. Participants will be considered not abstinent if they are lost to follow-up, report any smoking in the past 7 days, return a saliva sample with cotinine greater than or equal to 4 ng/ml, or fail to return a usable saliva sample. |
Countries
United States
Participant flow
Recruitment details
A total of 1316 of the target 1408 participants were recruited between June 2018 and January 2023
Participants by arm
| Arm | Count |
|---|---|
| 1-Call, Patch, SmokefreeTXT, Financial Incentive Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement | 83 |
| 1-Call, Patch, SmokefreeTXT, No Financial Incentive Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement | 84 |
| 1-Call, Patch, No SmokefreeTXT, Financial Incentive Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment | 80 |
| 1-Call, Patch, No SmokefreeTXT, No Financial Incentive Participants received: 1 quitline counseling call, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement | 85 |
| 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and financial incentives for treatment engagement | 82 |
| 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, SmokefreeTXT information, and no financial incentives for treatment engagement | 82 |
| 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and financial incentives for treatment engagement | 84 |
| 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive Participants received: 1 quitline counseling call, 4 weeks of nicotine patch and nicotine lozenges, no SmokefreeTXT information, and no financial incentives for treatment engagement | 82 |
| 4-Call, Patch, SmokefreeTXT, Financial Incentive Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and financial incentives for treatment engagement | 80 |
| 4-Call, Patch, SmokefreeTXT, No Financial Incentive Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, SmokefreeTXT information, and no financial incentives for treatment engagement | 81 |
| 4-Call, Patch, No SmokefreeTXT, Financial Incentive Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and financial incentives for treatment engagement | 81 |
| 4-Call, Patch, No SmokefreeTXT, No Financial Incentive Participants received: 4 quitline counseling calls, 2 weeks of nicotine patch, no SmokefreeTXT information, and no financial incentives for treatment engagement | 80 |
| 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and financial incentives for treatment engagement | 82 |
| 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, SmokefreeTXT information, and no financial incentives for treatment engagement | 85 |
| 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and financial incentives for treatment engagement | 82 |
| 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive Participants received: 4 quitline counseling calls, 4 weeks of nicotine patch and nicotine lozenge, no SmokefreeTXT information, and no financial incentives for treatment engagement | 83 |
| Total | 1,316 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Incarcerated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 5 | 3 | 0 | 0 | 3 | 1 | 5 | 1 | 2 | 1 | 3 | 0 | 2 | 4 |
Baseline characteristics
| Characteristic | 1-Call, Patch, SmokefreeTXT, Financial Incentive | Total | 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | 4-Call, Patch, No SmokefreeTXT, Financial Incentive | 4-Call, Patch, SmokefreeTXT, No Financial Incentive | 4-Call, Patch, SmokefreeTXT, Financial Incentive | 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | 1-Call, Patch, No SmokefreeTXT, Financial Incentive | 1-Call, Patch, SmokefreeTXT, No Financial Incentive |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 51.24 years STANDARD_DEVIATION 12.36 | 53.13 years STANDARD_DEVIATION 11.91 | 53.81 years STANDARD_DEVIATION 12.23 | 53.40 years STANDARD_DEVIATION 11.75 | 54.41 years STANDARD_DEVIATION 12.27 | 52.80 years STANDARD_DEVIATION 12.25 | 54.25 years STANDARD_DEVIATION 12.26 | 53.49 years STANDARD_DEVIATION 12.06 | 51.78 years STANDARD_DEVIATION 12.58 | 52.11 years STANDARD_DEVIATION 13.03 | 54.12 years STANDARD_DEVIATION 11.84 | 53.73 years STANDARD_DEVIATION 11.08 | 51.15 years STANDARD_DEVIATION 11.79 | 53.43 years STANDARD_DEVIATION 12.45 | 52.55 years STANDARD_DEVIATION 11.36 | 55.04 years STANDARD_DEVIATION 10.34 | 52.82 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 49 Participants | 3 Participants | 3 Participants | 6 Participants | 3 Participants | 0 Participants | 5 Participants | 4 Participants | 2 Participants | 4 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 1259 Participants | 80 Participants | 78 Participants | 79 Participants | 79 Participants | 80 Participants | 75 Participants | 73 Participants | 78 Participants | 77 Participants | 80 Participants | 79 Participants | 81 Participants | 84 Participants | 75 Participants | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 8 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 14 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 349 Participants | 20 Participants | 24 Participants | 22 Participants | 22 Participants | 25 Participants | 22 Participants | 22 Participants | 22 Participants | 21 Participants | 25 Participants | 18 Participants | 22 Participants | 23 Participants | 19 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 6 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 76 Participants | 5 Participants | 3 Participants | 6 Participants | 5 Participants | 2 Participants | 5 Participants | 4 Participants | 3 Participants | 6 Participants | 6 Participants | 7 Participants | 5 Participants | 3 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 54 Participants | 866 Participants | 57 Participants | 53 Participants | 54 Participants | 55 Participants | 52 Participants | 54 Participants | 54 Participants | 54 Participants | 54 Participants | 52 Participants | 55 Participants | 54 Participants | 56 Participants | 52 Participants | 56 Participants |
| Region of Enrollment United States | 83 participants | 1316 participants | 83 participants | 82 participants | 85 participants | 82 participants | 80 participants | 81 participants | 81 participants | 80 participants | 82 participants | 84 participants | 82 participants | 82 participants | 85 participants | 80 participants | 84 participants |
| Sex: Female, Male Female | 46 Participants | 761 Participants | 47 Participants | 48 Participants | 49 Participants | 49 Participants | 45 Participants | 46 Participants | 45 Participants | 49 Participants | 48 Participants | 48 Participants | 48 Participants | 48 Participants | 47 Participants | 47 Participants | 51 Participants |
| Sex: Female, Male Male | 37 Participants | 553 Participants | 36 Participants | 33 Participants | 36 Participants | 33 Participants | 35 Participants | 35 Participants | 36 Participants | 31 Participants | 34 Participants | 36 Participants | 33 Participants | 34 Participants | 38 Participants | 33 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 83 | 0 / 84 | 2 / 80 | 0 / 85 | 0 / 82 | 1 / 82 | 0 / 84 | 1 / 82 | 1 / 80 | 1 / 81 | 0 / 81 | 0 / 80 | 1 / 82 | 1 / 85 | 0 / 82 | 1 / 83 |
| other Total, other adverse events | 0 / 83 | 0 / 84 | 0 / 80 | 0 / 85 | 0 / 82 | 0 / 82 | 0 / 84 | 0 / 82 | 0 / 80 | 0 / 81 | 0 / 81 | 0 / 80 | 0 / 82 | 0 / 85 | 0 / 82 | 0 / 83 |
| serious Total, serious adverse events | 7 / 83 | 5 / 84 | 11 / 80 | 12 / 85 | 11 / 82 | 4 / 82 | 10 / 84 | 5 / 82 | 6 / 80 | 12 / 81 | 12 / 81 | 10 / 80 | 5 / 82 | 10 / 85 | 7 / 82 | 12 / 83 |
Outcome results
Primary
7-Day Point-Prevalence Abstinence
Participants will be coded as abstinent if they self-report no smoking for the past 7 days at the assessment endpoint (6 month follow-up) and provide a saliva sample for cotinine testing with a value of \<4 ng/ml. Participants will be considered not abstinent if they are lost to follow-up, report any smoking in the past 7 days, return a saliva sample with cotinine greater than or equal to 4 ng/ml, or fail to return a usable saliva sample.
Time frame: 6-months
Population: All randomized participants were included in intent-to-treat analyses.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1-Call, Patch, SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 11 Participants |
| 1-Call, Patch, SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 7 Participants |
| 1-Call, Patch, No SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 8 Participants |
| 1-Call, Patch, No SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 10 Participants |
| 1-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 6 Participants |
| 1-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 10 Participants |
| 1-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 10 Participants |
| 1-Call, Patch+Loz, No SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 15 Participants |
| 4-Call, Patch, SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 4 Participants |
| 4-Call, Patch, SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 16 Participants |
| 4-Call, Patch, No SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 10 Participants |
| 4-Call, Patch, No SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 7 Participants |
| 4-Call, Patch+Loz, SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 12 Participants |
| 4-Call, Patch+Loz, SmokefreeTXT, No Financial Incentive | 7-Day Point-Prevalence Abstinence | 8 Participants |
| 4-Call, Patch+Loz, No SmokefreeTXT, Financial Incentive | 7-Day Point-Prevalence Abstinence | 16 Participants |
| 4-Call, Patch+Loz, No SmokefreeTXT,No Financial Incentive | 7-Day Point-Prevalence Abstinence | 12 Participants |