Changing the Default for Tobacco Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 7-day Point-prevalence Abstinence
研究概览
简要总结
The purpose of this study is to determine the impact and efficacy of a new approach to smoking cessation treatment versus the traditional approach.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Admission greater than 3 days
研究组 & 干预措施
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.
干预措施: Opt Out Treatment Program (Behavioral)
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.
干预措施: Nicotine Replacement Therapy (Drug)
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.
干预措施: Opt In Treatment Program (Behavioral)
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.
干预措施: Nicotine Replacement Therapy (Drug)
结局指标
主要结局
7-day Point-prevalence Abstinence
时间窗: Month 1
7-day, self-reported and verified cigarette abstinence.
次要结局
- Treatment Engagement(Month 1)
- 7-day Point-prevalence Abstinence(Month 6)
- Default-theory Based Measures(Month 1)