Tobacco Use Cessation
Conditions
Keywords
tobacco treatment
Brief summary
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
Detailed description
In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care. For tobacco users, the default treatment is for them to opt in to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back yes. This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit. This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, standard of care approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.
Interventions
BEHAVIORALOpt Out Treatment Program
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
DRUGNicotine Replacement Therapy
Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
BEHAVIORALOpt In Treatment Program
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Speak English or Spanish * Have access to a telephone or mobile phone * Not be currently pregnant or breast feeding * Have no significant co-morbidity that precludes participation * Current daily smoker * Not in treatment for tobacco dependence * Reside in Kansas or Missouri
Exclusion criteria
* Admission greater than 3 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point-prevalence Abstinence | Month 1 | 7-day, self-reported and verified cigarette abstinence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Engagement | Month 1 | Percentages of participants who use cessation medications and participate in counseling post discharge |
| Default-theory Based Measures | Month 1 | We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form. |
| 7-day Point-prevalence Abstinence | Month 6 | 7-day, self-reported and verified cigarette abstinence. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | Month 6 | Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER). The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms. ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Opt Out Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by opting out. Participant will receive a Opt Out treatment program. Participants will receive counseling and nicotine replacement therapy.
Opt Out Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Nicotine Replacement Therapy: Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria. | 469 |
| Opt In Traditional approach to tobacco treatment program. Participants must first indicate they are ready to quit smoking by opting in to receive Opt In treatment program.
Opt In Treatment Program: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
Nicotine Replacement Therapy: Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria. | 270 |
| Total | 739 |
Baseline characteristics
| Characteristic | Opt Out | Opt In | Total |
|---|---|---|---|
| Age, Continuous | 51.21 years STANDARD_DEVIATION 14.8 | 51.70 years STANDARD_DEVIATION 14.56 | 51.39 years STANDARD_DEVIATION 14.71 |
| Race/Ethnicity, Customized Hispanic | 32 Participants | 11 Participants | 43 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 83 Participants | 49 Participants | 132 Participants |
| Race/Ethnicity, Customized Non-Hispanic multiracial | 75 Participants | 51 Participants | 126 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 270 Participants | 158 Participants | 428 Participants |
| Region of Enrollment United States | 469 participants | 270 participants | 739 participants |
| Sex: Female, Male Female | 226 Participants | 123 Participants | 349 Participants |
| Sex: Female, Male Male | 243 Participants | 147 Participants | 390 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 655 | 19 / 345 |
| other Total, other adverse events | 0 / 655 | 0 / 345 |
| serious Total, serious adverse events | 191 / 655 | 89 / 345 |
Outcome results
Primary
7-day Point-prevalence Abstinence
7-day, self-reported and verified cigarette abstinence.
Time frame: Month 1
Population: We calculated the Bayesian Posterior Probability (BPP) and Bayesian 95% Credible Intervals for all outcomes. ClinicalTrials.gov has no option to select these, so the labels for the credible intervals will appear as confidence intervals
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opt Out | 7-day Point-prevalence Abstinence | 21.5 Percentage of participants quit at 1-mo |
| Opt In | 7-day Point-prevalence Abstinence | 15.8 Percentage of participants quit at 1-mo |
Secondary
7-day Point-prevalence Abstinence
7-day, self-reported and verified cigarette abstinence.
Time frame: Month 6
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opt Out | 7-day Point-prevalence Abstinence | 18.57 Percentage of participants quit at 6-mo |
| Opt In | 7-day Point-prevalence Abstinence | 17.90 Percentage of participants quit at 6-mo |
Secondary
Default-theory Based Measures
We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.
Time frame: Month 1
Population: BPP and credible intervals
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opt Out | Default-theory Based Measures | 88.41 % felt they had control over quitting |
| Opt In | Default-theory Based Measures | 86.64 % felt they had control over quitting |
Secondary
Treatment Engagement
Percentages of participants who use cessation medications and participate in counseling post discharge
Time frame: Month 1
Population: Accepted a post-discharge script for medication
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Opt Out | Treatment Engagement | 87.68 Percentage of participants w/script |
| Opt In | Treatment Engagement | 37.84 Percentage of participants w/script |
Other Pre-specified
Cost-effectiveness
Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER). The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms. ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies.
Time frame: Month 6