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.

Background: Smoking cessation interventions implemented in emergency department (ED) settings have resulted in limited success, owing to factors such as lack of time, motivation, and incentives. A dynamic yet simple and effective approach that addresses the fast-paced nature of acute-care ED settings is needed. This study proposes a multi-center randomized controlled trial (RCT) to compare the effectiveness of an easy to deliver proactive, multi-component tobacco treatment intervention to usual care in the ED setting.

Methods: This will be a prospective four-site, single-blind, blinded-endpoint (PROBE) RCT. Participants will be recruited directly in the ED and will be approached strictly in order of arrival time. Those randomized to the Quit Card Intervention (QCI) group will receive a "quit kit" which will include: a "Quit Card" worth $300 that can be used at any Canadian pharmacy to purchase any form of nicotine replacement therapy (NRT); a self-help booklet; and proactive enrolment in 6 months of telephone follow-up counseling. The usual care (UC) group will receive a "quit kit" which will include a brochure for a local smoking cessation program. Quit kits for both groups will be delivered in opaque, sealed envelopes, and identical in size and weight so to conceal group allocation from the blinded research coordinator. Randomization will be stratified by site and by the Canadian Triage Acuity Scale (CTAS), a value assigned to each ED patient based on the severity of the condition. An equal number of quit kits will be prepared for each CTAS level. The primary outcome will be bio-chemically verified smoking abstinence at 26 weeks. Secondary outcomes include smoking behavior at weeks 4, 52, and 104 as well as mortality and health care utilization outcomes. Investigators, outcome assessors, and data analysts will be blinded to group allocation until after primary analyses are completed. It is hypothesized that the QCI group will have higher a abstinence rate, improved health outcomes, and decreased healthcare utilization.

Discussion: There are few examples of hospital EDs in Canada that systematically initiate tobacco cessation interventions for patients who smoke. Given the high smoking prevalence among ED patients and the relation of tobacco smoking to the majority of ambulatory care sensitive conditions, EDs are a missed opportunity in the initiation of tobacco treatment interventions. We have designed and will test an evidence-based tobacco treatment intervention that is simple and highly scalable.

Trial Registration: ClinicalTrials.gov NCT04163081 . Registered on November 14, 2019.