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

Nicotine Dependence, Cigarettes Clinical Trial

— INITIATE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04163081
• Other study ID #: 20190485-01H
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1208
• Est. completion date: November 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Nicotine Dependence, Cigarettes
• Nicotine Withdrawal
• Tobacco Use Disorder

Intervention

Behavioral:
• Quit 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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Civic Campus	Ottawa	Ontario
Canada	The Ottawa Hospital General Campus	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Point Prevalence Abstinence	Point prevalence smoking abstinence, at 4, 52 and 104 weeks	4, 52 and 104 weeks after study enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Cost-Effectiveness Ratios	Cost-effectiveness ratios related to health services at 52 and 104 weeks	52 and 104 weeks after study enrollment