Changing the Default for Tobacco Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Changing the Default for Tobacco Treatment

Conditions
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Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Opt Out Treatment Program
* Drug: Nicotine Replacement Therapy
* Behavioral: Opt In Treatment Program
* Drug: Nicotine Replacement Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Opt Out<br>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. | Behavioral: Opt Out Treatment Program<br>* Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.<br>Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Nicotine gum;|
| Active Comparator: Opt In<br>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. | Behavioral: Opt In Treatment Program<br>* 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.<br>Drug: Nicotine Replacement Therapy<br>* 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.<br>* Other names: Nicotine gum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 1 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Month 1 | 
| 7-day Point-prevalence Abstinence | 7-day, self-reported and verified cigarette abstinence. | Month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco treatment