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NCT Number: NCT04163081

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Civic Hospital, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quit Card Intervention (QCI)

Behavioral

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.

Primary outcomes

  1. Smoking Abstinence

    Time frame: 26 weeks (6 months) after study enrollment

    Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test

Secondary outcomes

  1. Prolonged Abstinence

    Time frame: 4, 26, and 52 weeks after study enrollment

    Prolonged (since last time point) smoking abstinence, at 4, 26, and 52 weeks

  2. Point Prevalence Abstinence

    Time frame: 4, and 52 weeks after study enrollment

    Point prevalence smoking abstinence, at 4, and 52 weeks

  3. Smoking Reduction

    Time frame: 4, 26, and 52 weeks after study enrollment

    Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, and 52 weeks

  4. Number of Quit Attempts

    Time frame: 4, 26, and 52 weeks after study enrollment

    Number of quit attempts since study entry, at 4, 26, and 52 weeks

  5. Cessation Medication and/or E-cigarette Use

    Time frame: 4, 26, and 52 weeks after study enrollment

    Use of smoking cessation medication and/or e-cigarette, at 4, 26, and 52 weeks

  6. Use of Behavioural Supports

    Time frame: 4, 26, and 52 weeks after study enrollment

    Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, and 52 weeks

  7. Health-Related Quality of Life

    Time frame: 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.

  8. Health Services Outcomes - ED visits

    Time frame: 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

  9. Health Services Outcomes - Hospital Admissions

    Time frame: 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

  10. Health Services Outcomes - Deaths

    Time frame: 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

  11. Cost-Effectiveness Ratios

    Time frame: 52 weeks after study enrollment

    Cost-effectiveness ratios related to health services at 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Chantelle Masterson, BPhil

CONTACT

[email protected]

613-696-7000 ext. 19157

Evyanne Wooding, R.Kin

CONTACT

[email protected]

613-696-7000 ext. 17596

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: INITIATE

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Nov 14, 2019
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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