跳至主要内容
临床试验/NCT04163081
NCT04163081招募中不适用

The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments

Ottawa Heart Institute Research Corporation7 个研究点 分布在 1 个国家目标入组 1,208 人开始时间: 2022年4月19日最近更新:
适应症
干预措施

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)

Experimental

Study intervention group.

干预措施: Quit Card Intervention (QCI) (Behavioral)

Usual Care (UC)

No Intervention

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

Loading locations...

相似试验