Perioperative Smoking Cessation Interventions
Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation
研究概览
地位
条件
详细说明
Purpose & Objective: Behavioral interventions in surgical patients are an opportunity to improve outcomes through decreased complications, with measurable economic impact. Smoking cessation is one of the most desirable long-term health behaviors for adults with potential substantial impact on postoperative complications
Study Activity & Population Group: The investigators propose a precommitment contractual agreement implementing behavioral economic principles at the preoperative appointment for active tobacco users undergoing an operation and assessing for ability to quit smoking with testing on the day of surgery, and the durability of cessation over the postoperative course as measured with urine nicotine testing at follow up appointments. The population of interest is adults who currently smoke tobacco or vaporized nicotine who are scheduled to undergo a major operation. The control group is standard of care; prescriptive advice to quit smoking. The intervention is contract agreement for preoperative cessation.
Data Analysis & Risk Issues: Following informed consent patients will be randomized to control or intervention groups, baseline urine nicotine tests will be performed in clinic. Urine nicotine testing will be performed on the day of enrollment, the day of their operation, and at their one-month follow up appointments. Thirty-day outcomes will be evaluated by retrospective chart review.
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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North Carolina
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Durham、North Carolina、美国、27710
- Duke University 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:
- active tobacco use
- preoperative appointment for an operation within 6 weeks
Exclusion Criteria:
- active enrollment in tobacco cessation program
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 |
|---|---|
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无干预：Control: Prescriptive Advice
Amenable patients will be enrolled into the study, their intervention will be current standard of care smoking cessation counseling by their surgeon, they will undergo 3 urine tests and a chart review for outcomes.
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实验性的：Intervention1: Contract Agreement
Amenable patients will be enrolled into the study, their intervention will be a smoking cessation contract with their surgeon, they will undergo 3 urine tests and a chart review for outcomes.
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Smoking Cessation Contract
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实验性的：Intervention2: Implementation Intentions
Amenable patients will be enrolled into the study, their intervention will be a worksheet to fill out with their smoking cessation implementation intentions that will be signed by patient and surgeon, they will undergo 3 urine tests and a chart review for outcomes.
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Smoking Cessation Contract with worksheet for implementation intentions
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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 |
|---|---|---|
|
Smoking Cessation
大体时间：day of surgery
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Smoking Cessation on Day of Surgery: quantitative point of care urine cotinine test
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day of surgery
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Smoking Cessation
大体时间：day of first postoperative appointment
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Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test
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day of first postoperative appointment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative Complications
大体时间：30 days postoperatively
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National Surgical Quality Improvement Project postoperative complications: based on patient chart review
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30 days postoperatively
|
合作者和调查者
调查人员
- 首席研究员：Christopher R Mantyh, MD、DUKE DEPARTMENT OF SURGERY
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 (实际的)
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
与本研究相关的术语
其他研究编号
- Pro00076125
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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