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

NCT ID: NCT04163081

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-19
• Study Completion Date: 2027-03-31

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.

Conditions

Nicotine Dependence, Cigarettes; Nicotine Withdrawal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Quit Card Intervention (QCI)

Study intervention group.

Group Type: EXPERIMENTAL

Quit Card Intervention (QCI)

Intervention Type: 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.

Usual Care (UC)

Study control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerri-Anne Mullen, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Heart Institute Research Corporation

Locations

Civic Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

General Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Riverside Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Chantelle Masterson, BPhil

Role: CONTACT

cmasterson@ottawaheart.ca

613-696-7000 ext. 19157

Evyanne Wooding, R.Kin

Role: CONTACT

ewooding@ottawaheart.ca

613-696-7000 ext. 17596

Facility Contacts

Dr. Venkatesh Thiruganasambandamoorthy

Role: primary

vthirug@toh.ca

6137985555,17023

Dr. Venkatesh Thiruganasambandamoorthy

Role: primary

vthirug@toh.ca

6137985555,17023

Dr. Venkatesh Thiruganasambandamoorthy

Role: primary

vthirug@toh.ca

6137985555,17023

Dr. Kerri-Anne Mullen

Role: primary

KMullen@ottawaheart.ca

613-696-7000 ext.19095

References

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.

Reference Type: DERIVED

PMID: 34688291 (View on PubMed)

Other Identifiers

20190485-01H

Identifier Type: -

Identifier Source: org_study_id