About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Parallel
Treatments tested in this trial
Quit Card Intervention (QCI)
BehavioralThe intervention is comprised of a behavioural incentive in the form of a gift card as well as tailored smoking cessation counseling. Eligible consenting smokers randomized to the QCI group will receive: a "Quit Card" (a gift card worth $300 that can be used to buy nicotine replacement therapies at any pharmacy); self-help information; and, enrollment in six months of telephone follow-up support tailored by treatment goal with a Nicotine Addiction Treatment Specialist.
Treatment groups
Trial outcomes
Primary outcomes
Smoking Abstinence
Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test
Secondary outcomes
Prolonged Abstinence
Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks
Point Prevalence Abstinence
Point prevalence smoking abstinence, at 4, and 52 weeks
Smoking Reduction
Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks
Number of Quit Attempts
Number of quit attempts since study entry, at 4, 26, and 52 weeks
Sponsors and contacts
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Ottawa Heart Institute Research Corporation
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator