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

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.MethodsThis 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 an d 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, ...
Source: Trials - Category: Research Source Type: clinical trials