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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quit Card Intervention (QCI) | Experimental | Study intervention group. |
|
| Usual Care (UC) | No Intervention | Study control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quit Card Intervention (QCI) | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Abstinence | Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test | 26 weeks (6 months) after study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Abstinence | Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Point Prevalence Abstinence | Point prevalence smoking abstinence, at 4, and 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chantelle Masterson, BPhil | Contact | 613-696-7000 | 19157 | cmasterson@ottawaheart.ca |
| Evyanne Wooding, R.Kin | Contact | 613-696-7000 | 17596 | ewooding@ottawaheart.ca |
| Name | Affiliation | Role |
|---|---|---|
| Kerri-Anne Mullen, PhD | Ottawa Heart Institute Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Civic Hospital | Recruiting | Ottawa | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34688291 | Derived | Mullen KA, Garg A, Gagnon F, Wells G, Kapur A, Hawken S, Pipe AL, Walker K, Thiruganasambandamoorthy V, Klepaczek M, Reid RD. The INITIATE trial protocol: a randomized controlled trial testing the effectiveness of a "quit card" intervention on long-term abstinence among tobacco smokers presenting to the emergency department. Trials. 2021 Oct 23;22(1):733. doi: 10.1186/s13063-021-05693-9. |
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|
| 4, and 52 weeks after study enrollment |
| Smoking Reduction | Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Number of Quit Attempts | Number of quit attempts since study entry, at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Cessation Medication and/or E-cigarette Use | Use of smoking cessation medication and/or e-cigarette, at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Use of Behavioural Supports | Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Health-Related Quality of Life | Health-related quality of life (HR-QoL), at 52 weeks. This will be measured using the Hospital Anxiety and Depression Scale (HADS), designed to identify and measure the levels of anxiety and depression among individuals in non-psychiatric hospital settings, and the Health Questionnaire Assessment (EQ-5D-5L), using five graded severity levels to summarize perceived health across five foundational dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | 52 weeks after study enrollment |
| Health Services Outcomes - ED visits | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Health Services Outcomes - Hospital Admissions | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Health Services Outcomes - Deaths | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, and 52 weeks | 4, 26, and 52 weeks after study enrollment |
| Cost-Effectiveness Ratios | Cost-effectiveness ratios related to health services at 52 weeks | 52 weeks after study enrollment |
| General Hospital | Recruiting | Ottawa | Ontario | Canada |
|
| Riverside Hospital | Recruiting | Ottawa | Ontario | Canada |
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| University of Ottawa Heart Institute | Recruiting | Ottawa | Ontario | Canada |
|
| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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