The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,208
- 试验地点
- 7
- 主要终点
- Smoking Abstinence
研究概览
简要总结
The INITIATE Study is a randomized controlled trial that is testing an intervention designed to increase long-term abstinence among tobacco smokers seen in emergency departments (ED) and other high-volume hospital and community ambulatory care settings. The intervention includes a behavioural incentive and tailored follow-up support on long-term smoking abstinence, health, healthcare utilization, and cost. Tobacco-related illnesses cost the healthcare system millions each year. Quitting smoking improves smoking-related outcomes, like the onset or management of heart disease, stroke, lung diseases, and several cancers. There are approximately 16 million visits to Canadian EDs each year; an estimated 3-4 million of these involve smokers. Effective quit smoking interventions exist, but are underutilized. Few hospital EDs, community healthcare centers, and other inpatient and outpatient clinics in Canada offer tobacco-use interventions. In order for clinicians to offer quit smoking support, interventions need to be simple given the realities of these high-volume environments. Considering that stopping smoking improves health outcomes, that tobacco-use is an important cause of preventable ED use, and the volume of smokers, Canadian EDs and other high-volume hospital and community ambulatory care settings are a missed opportunity in the initiation of quit smoking support. Our intervention has been designed to optimize uptake and smoking abstinence by including the most effective evidence-based behavioural and drug-related approaches, removing specific barriers and challenges that smokers face when trying to quit (e.g., affordability, low confidence and motivation), while packaging the intervention in a quick-to-initiate manner, making it ideal for fast-paced, complex environments.
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
- Double (Investigator, Outcomes Assessor)
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
- •Current daily smoker (smokes ≥ 5 cigarettes per day);
- •≥ 18 years of age (the age of majority in Ontario);
- •For ED sites only, assigned a CTAS level of 2-5 (emergent to non-urgent);
- •Able to read and understand English or French;
- •Resides in Ontario and eligible for Ontario Health Insurance Plan (to permit linkage with administrative data housed at the Institute for Clinical Evaluative Sciences [ICES]);
- •Available and willing to participate in follow-up assessments over the next 12 months;
- •Has access to a telephone or computer;
- •Able to provide informed consent
排除标准
- •Currently participating in this or another smoking cessation study;
- •For ED sites only, assigned a CTAS level of 1 (resuscitation - the most seriously ill patients with highest likelihood of hospital admission) or in psychiatric emergency unit;
- •Pregnant, planning to become pregnant over the next year, or breastfeeding;
- •Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care);
- •In the opinion of the attending physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.
- •Scheduled for a known elected surgery, procedure, or future hospitalization during the study period.
研究组 & 干预措施
Quit Card Intervention (QCI)
Study intervention group.
干预措施: Quit Card Intervention (QCI) (Behavioral)
Usual Care (UC)
Study control group.
结局指标
主要结局
Smoking Abstinence
时间窗: 26 weeks (6 months) after study enrollment
Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test
次要结局
- Prolonged Abstinence(4, 26, and 52 weeks after study enrollment)
- Health Services Outcomes - ED visits(4, 26, and 52 weeks after study enrollment)
- Point Prevalence Abstinence(4, and 52 weeks after study enrollment)
- Number of Quit Attempts(4, 26, and 52 weeks after study enrollment)
- Cessation Medication and/or E-cigarette Use(4, 26, and 52 weeks after study enrollment)
- Health-Related Quality of Life(52 weeks after study enrollment)
- Smoking Reduction(4, 26, and 52 weeks after study enrollment)
- Use of Behavioural Supports(4, 26, and 52 weeks after study enrollment)
- Health Services Outcomes - Hospital Admissions(4, 26, and 52 weeks after study enrollment)
- Health Services Outcomes - Deaths(4, 26, and 52 weeks after study enrollment)
- Cost-Effectiveness Ratios(52 weeks after study enrollment)
