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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL131512 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opt Out | Experimental | 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 In | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opt Out Treatment Program | Behavioral | Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Engagement | Percentages of participants who use cessation medications and participate in counseling post discharge | Month 1 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimber Richter, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36848129 | Derived | Richter KP, Catley D, Gajewski BJ, Faseru B, Shireman TI, Zhang C, Scheuermann TS, Mussulman LM, Nazir N, Hutcheson T, Shergina E, Ellerbeck EF. The Effects of Opt-out vs Opt-in Tobacco Treatment on Engagement, Cessation, and Costs: A Randomized Clinical Trial. JAMA Intern Med. 2023 Apr 1;183(4):331-339. doi: 10.1001/jamainternmed.2022.7170. | |
| 35435813 | Derived | Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | 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" | Posted | Mean | 95% Confidence Interval | Percentage of participants quit at 1-mo | Month 1 |
|
Adverse event data were collect for 6 months following randomization
Definitions do not differ from those of clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, Hospitalization, or Life threatening illness | General disorders | Non-systematic Assessment | Most adverse events were repeat hospitalizations, which is common in a population recruited during hospital admission |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kimber Richter | U. Kansas Medical Center | 9134490157 | krichter@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2021 | Jul 18, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 1, 2021 | Jul 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D061485 | Tobacco Use Cessation Devices |
| D000074164 | Nicotine Chewing Gum |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002638 | Chewing Gum |
| D053149 | Plant Gums |
| D001704 |
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| Nicotine Replacement Therapy | Drug | 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. |
|
|
| Opt In Treatment Program | Behavioral | 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 | Drug | 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. |
|
|
| Month 1 |
| 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 6 |
| Month 6 |
| 28806908 | Derived | Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Treatment Engagement | Percentages of participants who use cessation medications and participate in counseling post discharge | Accepted a post-discharge script for medication | Posted | Mean | 95% Confidence Interval | Percentage of participants w/script | Month 1 |
|
|
|
| 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. | BPP and credible intervals | Posted | Mean | 95% Confidence Interval | % felt they had control over quitting | Month 1 |
|
|
|
| Secondary | 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Posted | Mean | 95% Confidence Interval | Percentage of participants quit at 6-mo | Month 6 |
|
|
|
| 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. | Not Posted | Month 6 | Participants |
| 27 |
| 655 |
| 191 |
| 655 |
| 0 |
| 655 |
| EG001 | 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. | 19 | 345 | 89 | 345 | 0 | 345 |
|
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| Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D002182 | Candy |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |