Helping smokers quit during emergency department visits
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
This study is testing a new way to help daily smokers quit by giving them support and incentives during their emergency department visits to see if it helps them stay smoke-free for longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 4 sites (Ottawa, Ontario and 3 other locations) |
| Trial ID | NCT04163081 on ClinicalTrials.gov |
What this trial studies
The INITIATE Study is a randomized controlled trial aimed at increasing long-term smoking abstinence among tobacco smokers who visit emergency departments. It involves a Quit Card Intervention (QCI) that provides behavioral incentives and tailored follow-up support to participants. The study targets smokers who are daily users of tobacco and assesses the impact of the intervention on smoking cessation, health outcomes, and healthcare utilization over a 24-month period. With millions of emergency department visits involving smokers each year, this study seeks to address the underutilization of effective smoking cessation interventions in healthcare settings.
Who should consider this trial
Good fit: Ideal candidates for this study are current daily smokers aged 18 and older who visit emergency departments in Ontario.
Not a fit: Patients who are not current smokers or those with severe health conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve smoking cessation rates among patients who visit emergency departments.
How similar studies have performed: Other studies have shown success with similar interventions in promoting smoking cessation, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ottawa, Ontario and 3 other locations
- Civic Hospital — Ottawa, Ontario, Canada (Recruiting)
- General Hospital — Ottawa, Ontario, Canada (Recruiting)
- Riverside Hospital — Ottawa, Ontario, Canada (Recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Kerri-Anne Mullen, PhD — Ottawa Heart Institute Research Corporation
- Study coordinator: Chantelle Masterson, BPhil
- Email: cmasterson@ottawaheart.ca
- Phone: 613-696-7000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.