The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
- Conditions
- Nicotine WithdrawalNicotine Dependence, Cigarettes
- Interventions
- Behavioral: Quit Card Intervention (QCI)
- Registration Number
- NCT04163081
- Lead Sponsor
- Ottawa Heart Institute Research Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1208
- 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 24 months;
- Has access to a telephone or computer;
- Able to provide informed consent
- 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 2 years, 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Quit Card Intervention (QCI) Quit Card Intervention (QCI) Study intervention group.
- Primary Outcome Measures
Name Time Method Smoking Abstinence 26 weeks (6 months) after study enrollment Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test
- Secondary Outcome Measures
Name Time Method Point Prevalence Abstinence 4, 52 and 104 weeks after study enrollment Point prevalence smoking abstinence, at 4, 52 and 104 weeks
Number of Quit Attempts 4, 26, 52 and 104 weeks after study enrollment Number of quit attempts since study entry, at 4, 26, 52 and 104 weeks
Health Services Outcomes - ED visits 4, 26, 52 and 104 weeks after study enrollment Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, 52 and 104 weeks
Health Services Outcomes - Deaths 4, 26, 52 and 104 weeks after study enrollment Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, 52 and 104 weeks
Smoking Reduction 4, 26, 52 and 104 weeks after study enrollment Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, 52 and 104 weeks
Cessation Medication and/or E-cigarette Use 4, 26, 52 and 104 weeks after study enrollment Use of smoking cessation medication and/or e-cigarette, at 4, 26, 52 and 104 weeks
Use of Behavioural Supports 4, 26, 52 and 104 weeks after study enrollment Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, 52 and 104 weeks
Health Services Outcomes - Hospital Admissions 4, 26, 52 and 104 weeks after study enrollment Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, 52 and 104 weeks
Prolonged Abstinence 4, 26, 52 and 104 weeks after study enrollment Prolonged (since last time point) smoking abstinence, at 4, 26, 52 and 104 weeks
Health-Related Quality of Life 52 and 104 weeks after study enrollment Health-related quality of life (HR-QoL), at 52 and 104 weeks. This will be measured using the 36-Item Short Form Health Survey (SF-36), where each item is scored so that the lowest and highest possible scores are 0 and 100 respectively, and a high score outlines a more favorable state of health.
Cost-Effectiveness Ratios 52 and 104 weeks after study enrollment Cost-effectiveness ratios related to health services at 52 and 104 weeks
Trial Locations
- Locations (3)
University of Ottawa Heart Institute
🇨🇦Ottawa, Ont', Canada
Civic Hospital
🇨🇦Ottawa, Ontario, Canada
General Hospital
🇨🇦Ottawa, Ontario, Canada