Effectiveness of Inpatient Initiated Varenicline Tartrate for Smoking Cessation, for Smoking Related Illnesses.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 392
- 试验地点
- 3
- 主要终点
- Smoking abstinence
研究概览
简要总结
The Smoking Termination Opportunity for inPatients, (STOP) project is designed to capture the opportunity that is provided by admission for acute smoking related illness, to assist patients through withdrawal by use of a combination of:
- the new medication Champix with
- best practice counselling
- initiated in an inpatient setting
to achieve:
- sustained smoking abstinence
- reduced hospital bed and health service utilisation
- reduced inpatient smoking and craving prior to discharge
详细描述
A national standard in public hospitals for the management of smoking in patients admitted with smoking related acute illnesses is lacking. Where such patients have continued to smoke up until the time of admission, it can be assumed that "primary" prevention has failed.
Once admitted, there is a vastly under-utilised opportunity, by use of a structured and systematic approach, to intervene with a secondary prevention attempt. This takes advantage of the synergy of:
- the smoker is a "captive audience" and may be receptive to considering lifestyle factors that have lead to the admission, and
- best practice medication and counselling can be initiated prior to discharge. If proven to be cost-effective in our analysis, a systematic roll-out of this secondary prevention initiative would be advocated. ie translation of research into practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Smoker of at least 10 cigarettes per day on average over the past 12 months
- •Inpatient with an anticipation admission of at least one day
- •Willingness to quit smoking
- •Aged between 20 and 75 years
- •A plan of discharge to go home
- •Acute hospital admission with cardiovascular, cerebrovascular, peripheral vascular diseases or airways (asthma and/or Chronic Obstructive Pulmonary disease
排除标准
- •Subject preference to use an alternative pharmacotherapy for smoking cessation
- •Respiratory patient being considered for home oxygen
- •Pregnancy
- •Breast feeding
- •Acute or pre-existing severe psychiatric illnesses
- •Past history of psychosis or suicidal ideation
- •Renal impairment with creatinine clearance <30ml/min
研究组 & 干预措施
Champix plus counselling
varenicline tartrate will be initiated whilst subjects are inpatients with the standard MIMS dosing schedule (including period of titration). In combination with Quit SA (5A) telephone counselling service
干预措施: Champix (Drug)
counselling alone
5A counselling via Quit SA (quitline) telephone counselling service. (maximum 8 phone calls per subject within a 3 month period).
干预措施: Counselling alone (Behavioral)
结局指标
主要结局
Smoking abstinence
时间窗: one year
Continued smoking abstinence is defined as: less than or equal to no more than 5 cigarettes smoked during the period of 2 weeks to 12 months post enrollment.
次要结局
- Reduced hospital bed utilisation(one year)
- 7-day point prevalence(from 2 weeks to 3 months post enrollment)
- Reduction in health care costs(one year)
- Inpatient craving levels(baseline to end of inpatient stay)
- Prevalence of inpatient smoking(From baseline to end of inpatient stay)