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临床试验/NCT04487548
NCT04487548已完成不适用

Perioperative Smoking Cessation BUndle in a Tertiary Care Hospital - Can Turning Virtual Improve Outcomes? A Pilot Randomized Controlled Trial.

Fraser Health2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Uptake of smoking cessation resources

研究概览

简要总结

Smoking continues to be a burden to the healthcare system in Canada. It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. A quality improvement project at Royal Columbian Hospital recently showed that it is possible to implement a smoking cessation bundle for all current smokers during their preadmission clinic visit. However, due to the COVID-19 pandemic, much of the bundle was abandoned as it relied heavily on in-person interactions. The investigators wish to study the effect of a structured smoking cessation bundle, delivered remotely, on smoking cessation and postoperative complications. The aim is to determine the feasibility of giving the remotely delivered bundle to elective surgical patients before or around the time of a preadmission clinic visit, and whether it can reduce smoking rates and postoperative complications versus the standard uncoordinated advice.

详细描述

Introduction and Background Smoking continues to be a burden to the healthcare system in Canada. As of 2019, 3.7 million Canadians (12% of the population over age 15) reported being a current smoker. British Columbia's smoking rate is lower, but 10.2% of adults still regularly smoke cigarettes1. It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers. Pulmonary complications, cardiovascular complications, and surgical site infections are mediators of smoking-associated mortality at 6-months and 1-year after elective surgery.

Although there have been a handful of studies that have demonstrated dramatic reductions in postoperative complications with well-timed smoking cessation interventions in the preoperative period, these results have not translated into widespread clinical practice in delaying surgery for the purpose of achieving smoking cessation. In addition, most of these studies took place in Europe, where smokers may behave differently than in the Canadian setting.

A systematic review recommended at least 4 weeks of smoking cessation in order to reduce postoperative complications6. Several European studies have shown dramatic reductions in complications (up to 30% absolute risk reductions) when smoking cessation interventions have been implemented 4-8 weeks preoperatively. One Canadian editorial even suggested new policies be put into place to delay elective surgeries in smokers until a trial of cessation for 6 weeks had taken place.

Implementation of smoking cessation programs preoperatively have the potential to reduce morbidity and mortality. A Cochrane systematic review has shown that preoperative smoking cessation therapy improves both short and long-term smoking cessation. In fact, a surgical encounter with the healthcare system has been described as a "teachable moment" that provides motivation for patients to permanently stop smoking. Despite this information, most anesthesiologists do not routinely offer smoking cessation advice to their patients and advice, counselling, and pharmacotherapy for smoking cessation is not routine in pre-admission clinics across Canada and the United States.

Several small trials have shown that smoking cessation interventions can increase smoking cessation and reduce postoperative complications, particularly wound-healing complications, which can have an absolute risk reduction of up to 25%. Prior work by one of the co-investigators showed that a simple intervention in the pre-admission clinic was able to increase the abstinence rate from 3.6% to 14.3% on the day of surgery. Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation.

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
Double (Care Provider, Outcomes Assessor)

盲法说明

Blinding of study participants is not possible. Blinding of staff may not always be possible, although staff will not be informed which group the participant has been randomized to.

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

  • Adults aged 18 years and over.
  • Current smoker (self-identified from pre-surgical package).
  • Surgery date over 1 week away or not yet booked.

排除标准

  • Emergency surgery.
  • Smokers who only consume non-cigarette forms of tobacco (pipe, smokeless tobacco).
  • Smokers who only consume marijuana or vaping.
  • Patients who are pregnant or breastfeeding.
  • Inability to provide informed consent.
  • Currently enrolled in any other research study involving smoking cessation.

结局指标

主要结局

Uptake of smoking cessation resources

时间窗: 6 months postoperatively

The primary outcome is the participant's self-reported rate of uptake of smoking cessation information and accessing available resources. Uptake will be assessed by a brief questionnaire given at each of the follow-up time points asking which resources were accessed and if NRT was used.

次要结局

  • Cost of nicotine replacement therapy(6 months)
  • Number of nicotine replacement therapy pharmacy deliveries(6 months)
  • Participant satisfaction with smoking cessation bundle assessed by study questionnaire(8 weeks post-randomization)
  • Recruitment rate(Enrollment)
  • Recruitment timing(Enrollment)
  • Number of nicotine replacement therapy refills(6 months)
  • Change in smoking status from baseline(Day of surgery, 30 days postoperatively, 8 weeks post-randomization and 6 months postoperatively)
  • Hospital Length of Stay(First 30 days)
  • Postop complications (day 3 POMS)(Postop Day 3)

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Lee

Physician

Fraser Health

研究点 (2)

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