跳至主要内容
临床试验/NCT03222908
NCT03222908终止不适用

Evaluation of Surgical Outcomes in Patients Undergoing Pre-commitment and Social Contracting for Smoking Cessation

Duke University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
2
主要终点
Smoking Cessation

研究概览

简要总结

To assess impact of behavioral economic principles of precommitment, implementation intentions, and social contracting on smoking cessation for patients undergoing surgery.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • active tobacco use
  • preoperative appointment for an operation within 6 weeks

排除标准

  • active enrollment in tobacco cessation program

研究组 & 干预措施

Control: Prescriptive Advice

No Intervention

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.

Intervention1: Contract Agreement

Experimental

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.

干预措施: Intervention1: Contract Agreement (Behavioral)

Intervention2: Implementation Intentions

Experimental

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.

干预措施: Intervention2: Implementation Intentions (Behavioral)

结局指标

主要结局

Smoking Cessation

时间窗: day of first postoperative appointment

Smoking Cessation on first postoperative follow up appointment: quantitative point of care urine cotinine test

次要结局

  • Postoperative Complications(30 days postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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