Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Conditions
Keywords
Nicotine Replacement Therapy, Emergency Department, Nicotine Dependence, Tobacco Abstinence, Tobacco Treatment, Cigarette
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.
Interventions
BEHAVIORALQuit Card Intervention (QCI)
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.
Sponsors
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Prolonged Abstinence | 4, 26, and 52 weeks after study enrollment | Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks |
| Point Prevalence Abstinence | 4, and 52 weeks after study enrollment | Point prevalence smoking abstinence, at 4, and 52 weeks |
| Smoking Reduction | 4, 26, and 52 weeks after study enrollment | Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks |
| Number of Quit Attempts | 4, 26, and 52 weeks after study enrollment | Number of quit attempts since study entry, at 4, 26, and 52 weeks |
| Cessation Medication and/or E-cigarette Use | 4, 26, and 52 weeks after study enrollment | Use of smoking cessation medication and/or e-cigarette, at 4, 26, and 52 weeks |
| Use of Behavioural Supports | 4, 26, and 52 weeks after study enrollment | Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, and 52 weeks |
| Health-Related Quality of Life | 52 weeks after study enrollment | 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. |
| Health Services Outcomes - ED visits | 4, 26, and 52 weeks after study enrollment | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, and 52 weeks |
| Health Services Outcomes - Hospital Admissions | 4, 26, and 52 weeks after study enrollment | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, and 52 weeks |
| Health Services Outcomes - Deaths | 4, 26, and 52 weeks after study enrollment | Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, and 52 weeks |
| Cost-Effectiveness Ratios | 52 weeks after study enrollment | Cost-effectiveness ratios related to health services at 52 weeks |
Countries
Canada
Contacts
CONTACTChantelle Masterson, BPhil
CONTACTEvyanne Wooding, R.Kin
PRINCIPAL_INVESTIGATORKerri-Anne Mullen, PhD
Ottawa Heart Institute Research Corporation
Outcome results
None listed