The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
INITIATE
1 other identifier
interventional
1,208
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 14, 2019
CompletedStudy Start
First participant enrolled
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
May 6, 2026
April 1, 2026
4.4 years
October 7, 2019
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Prolonged Abstinence
4, 26, and 52 weeks after study enrollment
Point Prevalence Abstinence
4, and 52 weeks after study enrollment
Smoking Reduction
4, 26, and 52 weeks after study enrollment
Number of Quit Attempts
4, 26, and 52 weeks after study enrollment
Cessation Medication and/or E-cigarette Use
4, 26, and 52 weeks after study enrollment
- +6 more secondary outcomes
Study Arms (2)
Quit Card Intervention (QCI)
EXPERIMENTALStudy intervention group.
Usual Care (UC)
NO INTERVENTIONStudy control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Civic Hospital
Ottawa, Ontario, Canada
General Hospital
Ottawa, Ontario, Canada
Riverside Hospital
Ottawa, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Related Publications (1)
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.
PMID: 34688291DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kerri-Anne Mullen, PhD
Ottawa Heart Institute Research Corporation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2019
First Posted
November 14, 2019
Study Start
April 19, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share