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

Study Overview
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Brief Summary
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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). 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 in Canada offer tobacco-use interventions. In order for ED staff to offer quit smoking support, interventions need to be simple given the realities of the ED environment. 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 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 ED environments.

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

Conditions
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Nicotine Dependence, Cigarettes, Nicotine Withdrawal

Intervention / Treatment
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* Behavioral: Quit Card Intervention (QCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current daily smoker (smokes ≥ 5 cigarettes per day); ≥ 18 years of age (the age of majority in Ontario); 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 Exclusion Criteria: Currently participating in this or another smoking cessation study; 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 ED physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quit Card Intervention (QCI)<br>Study intervention group. | Behavioral: Quit Card Intervention (QCI)<br>* 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.<br>|
| No Intervention: Usual Care (UC)<br>Study control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged Abstinence | Prolonged (since last time point) smoking abstinence, at 4, 26, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Point Prevalence Abstinence | Point prevalence smoking abstinence, at 4, 52 and 104 weeks | 4, 52 and 104 weeks after study enrollment | 
| Smoking Reduction | Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Number of Quit Attempts | Number of quit attempts since study entry, at 4, 26, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Cessation Medication and/or E-cigarette Use | Use of smoking cessation medication and/or e-cigarette, at 4, 26, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Use of Behavioural Supports | Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Health-Related Quality of Life | 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. | 52 and 104 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, 52 and 104 weeks | 4, 26, 52 and 104 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, 52 and 104 weeks | 4, 26, 52 and 104 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, 52 and 104 weeks | 4, 26, 52 and 104 weeks after study enrollment | 
| Cost-Effectiveness Ratios | Cost-effectiveness ratios related to health services at 52 and 104 weeks | 52 and 104 weeks after study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Replacement Therapy, Emergency Department, Nicotine Dependence, Tobacco Abstinence, Tobacco Treatment, Cigarette