Smoking Cessation Program in the Preadmission Clinic
Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line
Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates
Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Ontario
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Toronto、Ontario、加拿大、M5T2S8
- Toronto Western Hospital, Department of Aneshtesia
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Toronto、Ontario、加拿大
- Mount Sinai Hospital, Department of Anesthesia
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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:
- Patients who smoke more than 10 cigarettes per day for more than 1 year
- And had no period of smoking abstinence longer than 3 months in the past year.
- Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age
Exclusion Criteria:
- Patients unwilling or unable to give informed consent
- Patients who are pregnant and breast feeding
- Patients with any psychiatric disorder
- Patients who used nicotine replacement / bupropion within previous 3 months
- Cardiovascular disease within the past 6 months
- Any serious or unstable disease within the past 6 months
- Drug or alcohol abuse within the past year.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 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 |
|---|---|
|
实验性的:Smoking cessation group
Counselling, Pharmacotherapy and Smokers Help Line
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The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
|
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其他:Control group
Brief informatin about quitting and smokers help line
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Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
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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 |
|---|---|---|
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pre-surgery counseling for quit smoking
大体时间:1 year after surgery
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In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions:
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1 year after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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perioperative complications
大体时间:3 months after surgery
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Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date.
The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program).
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3 months after surgery
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合作者和调查者
合作者
调查人员
- 首席研究员:Frances Chung, FRCPC、University Health Network, Toronto
研究记录日期
研究主要日期
学习开始
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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