Changing the Default for Tobacco Treatment
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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.
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Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
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.
其他名称:
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.
其他名称:
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有源比较器: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.
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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.
其他名称:
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.
其他名称:
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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
7-day Point-prevalence Abstinence
大体时间:Month 1
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7-day, self-reported and verified cigarette abstinence.
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Month 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Treatment Engagement
大体时间:Month 1
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Percentages of participants who use cessation medications and participate in counseling post discharge
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Month 1
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Default-theory Based Measures
大体时间:Month 1
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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.
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Month 1
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7-day Point-prevalence Abstinence
大体时间:Month 6
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7-day, self-reported and verified cigarette abstinence.
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Month 6
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cost-effectiveness
大体时间:Month 6
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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.
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Month 6
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合作者和调查者
调查人员
- 首席研究员:Kimber Richter, PhD、University of Kansas Medical Center
出版物和有用的链接
一般刊物
- 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.
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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