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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Smoking Abstinence [Time frame: 26 weeks (6 months) after study enrollment]

Secondary outcome measures (11)

• Prolonged Abstinence [Time frame: 4, 26, and 52 weeks after study enrollment]
• Point Prevalence Abstinence [Time frame: 4, and 52 weeks after study enrollment]
• Smoking Reduction [Time frame: 4, 26, and 52 weeks after study enrollment]
• Number of Quit Attempts [Time frame: 4, 26, and 52 weeks after study enrollment]
• Cessation Medication and/or E-cigarette Use [Time frame: 4, 26, and 52 weeks after study enrollment]
• Use of Behavioural Supports [Time frame: 4, 26, and 52 weeks after study enrollment]
• Health-Related Quality of Life [Time frame: 52 weeks after study enrollment]
• Health Services Outcomes - ED visits [Time frame: 4, 26, and 52 weeks after study enrollment]
• Health Services Outcomes - Hospital Admissions [Time frame: 4, 26, and 52 weeks after study enrollment]
• Health Services Outcomes - Deaths [Time frame: 4, 26, and 52 weeks after study enrollment]
• Cost-Effectiveness Ratios [Time frame: 52 weeks after study enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 4 centers

• Civic Hospital — Ottawa
• General Hospital — Ottawa
• Riverside Hospital — Ottawa
• University of Ottawa Heart Institute — Ottawa

Publications

• 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 34688291

Identifiers

NCT: NCT04163081 · 20190485-01H

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗