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临床试验/NCT02660957
NCT02660957已完成不适用

Effectiveness of a Brief, Self-determination Intervention for Smoking Cessation (Immediate or Progressive) Among People Attending Emergency Departments: a Randomised Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,571 人开始时间: 2015年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,571
试验地点
1
主要终点
smoking quit rate change from baseline at 6-month follow-up between intervention and control group

研究概览

简要总结

The purpose of this study is to test the effectiveness of using a brief, self-determination intervention on smoking cessation (immediate or progressive) for people attending AEDs.

详细描述

Cigarette smoking, which causes serious damage to health resulting in many chronic problems including cancer, heart disease, stroke and lung disease, is the single most important, preventable cause of death and diseases. It is therefore crucial that healthcare professionals should promote smoking cessation and help patients quit. The Hong Kong government and community have put enormous efforts on raising tobacco tax, smoke-free legislation, law enforcement, health promotion campaigns and smoking cessation services. The prevalence of daily cigarette smokers has been decreasing from 23.3% in 1982 to 10.7 % in 2012, which is one of the lowest around the world. Nevertheless, about half of the smokers remain reluctant to even try giving up smoking.

Medical attention at Accident and Emergency Departments (AEDs) of smokers who are in physical discomfort can be developed as an excellent "teachable model" as it provides an invaluable opportunity to initiate smoking cessation. Smokers consulting doctors as an emergency are more liable to change their habits to improve their health. According to the Hospital Authority, about 2 million people attend AEDs in Hong Kong each year, of whom 68% are triaged as semi-urgent (level 4) and non-urgent (level 5). The average waiting time for a medical consultation varies among AEDs, but is generally longer than 30 min for triage level 4 and 1-2 h for level 5 - presenting healthcare professionals with a golden opportunity to advise smokers to quit and on the available smoking cessation programmes while they are waiting. However, most of the cessation programmes, including stage-matched interventions, generally take several to more than 30 minutes to implement and hence are not practicable or feasible in busy clinical settings. Indeed, the most common reason cited by healthcare professionals for being unable to help patients to quit smoking is the lack of time, because they are very busy and cannot spare even a few extra minutes to do so. Other barriers include a lack of training and experience, a lack of confidence in the effectiveness of the interventions, and the absence of incentives and deficiencies in support or requirements by hospital management that these programmes should be implemented. Moreover, our previous smoking cessation projects in outpatient clinics have revealed that many patients are too impatient to undergo a long intervention and some are reluctant to participate for fear that they might miss or experience delays in their medical consultation or other medical procedures. To address such problems, further studies are warranted to develop brief and effective interventions with simple, direct, strong, evidence-based warnings for patients who smoke.

Smoking is addictive and quitting is very difficult, with a high rate of relapse, particularly among those with high nicotine dependency. Our previous smoking cessation projects in outpatient clinics and the community have revealed that many smokers who are reluctant to quit are interested in reducing the number of cigarettes smoked per day. Therefore, another potential option would be to help smokers to reduce the number of cigarettes smoked gradually, with the ultimate goal of complete cessation. Several randomised controlled trials in the West have supported that smoking reduction interventions can help smokers first reduce and eventually quit smoking.

What investigators have achieved to date:

Investigators conducted a 'proof-of-principle' pilot randomised controlled trial on a very brief (<30 s) smoking cessation intervention with a 'one in two smokers will be killed by smoking' warning in medical outpatient clinics in Guangzhou. The results showed that more of the smokers who received this brief advice quit or reduced their smoking than did not. This pilot study suggested that even a very brief intervention on smoking cessation is better than no advice in the 'real world' practice for outpatient clinics. Moreover, the study demonstrated the feasibility and acceptability of the implementation of a very brief smoking cessation programme by healthcare professionals in busy clinical settings. In addition, the findings support the need for large randomised controlled trials of brief or minimal interventions with the 'one in two' warning.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •aged 18 years or above
  • •triaged as semi-urgent (level 4) or non-urgent (level 5)
  • •current smokers, either occasional or daily
  • •express a willingness to quit smoking

排除标准

  • •poor cognitive state or mental illness
  • •participation in other smoking cessation programmes or services

研究组 & 干预措施

self-determination smoking cessation

Experimental

Subjects in the intervention group will be allowed to select their own schedules of quitting after discussing their situation with the counsellor (quit immediately (QI), or quit progressively (QP) with the ultimate goal of completing cessation over an acceptable period). Subjects in the intervention group will receive a self-help quitting leaflet published by the Hong Kong Council on Smoking and Health plus a series of brief interventions using the AWARD model.

干预措施: self-determination smoking cessation (Behavioral)

health life

Placebo Comparator

Subjects in the placebo control group will receive a smoking cessation leaflet published by the Hong Kong Council on Smoking and Health (COSH), as will the intervention group. Moreover, subjects in the placebo control group will undergo a similar schedule of telephone follow-up as those in the intervention group. They will receive a 'placebo' intervention with a 'placebo booster' of the same duration on increasing physical activity and fruit and vegetable intake.

干预措施: placebo comparator (Other)

结局指标

主要结局

smoking quit rate change from baseline at 6-month follow-up between intervention and control group

时间窗: 6-month follow-up

The primary outcome is biochemically validated abstinence at 6 months.

次要结局

  • smoking quit rate change from baseline at 12-month follow-up between intervention and control group(12-month follow-up)
  • self-efficacy against tobacco change from baseline at 6-month and 12-month follow-up between intervention and control group(6-month and 12-month follow-up)
  • smoking reduction rate change from baseline at 6-month and 12-month follow-up between intervention and control group(6-month and 12-month follow-up)
  • smoking quit rate change from baseline at 6-month and 12-month follow-up between intervention and control group(6-month and 12-month follow-up)
  • quality of life change from baseline at 6-month and 12-month follow-up between intervention and control group(6-month and 12-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. LI William Ho Cheung

Associate Professor

The University of Hong Kong

研究点 (1)

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