Changing the Default for Tobacco Treatment
Overview
- Phase
- Phase 4
- Intervention
- Opt Out Treatment Program
- Conditions
- Tobacco Use Cessation
- Sponsor
- University of Kansas Medical Center
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- 7-day Point-prevalence Abstinence
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Opt Out Treatment Program
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.
Intervention: Nicotine Replacement Therapy
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.
Intervention: Opt In Treatment Program
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.
Intervention: Nicotine Replacement Therapy
Outcomes
Primary Outcomes
7-day Point-prevalence Abstinence
Time Frame: Month 1
7-day, self-reported and verified cigarette abstinence.
Secondary Outcomes
- Treatment Engagement(Month 1)
- 7-day Point-prevalence Abstinence(Month 6)
- Default-theory Based Measures(Month 1)