Title {1}	The INITIATE trial: a randomized controlled trial testing the effectiveness of a “quit card” intervention on long-term abstinence among tobacco smokers presenting to the emergency department
Trial registration {2a and 2b}.	This trial is registered on ClinicalTrials.gov with the registration number NCT04163081.
Protocol version {3}	Issue Date: Jan 26, 2020 Protocol Amendment Number: 4 Author(s): KAM; AG; FG; GW; AK; SH; ALP; KW; VT; MK; RDR Revision chronology: • INITIATE Original – June 2019 • INITIATE Amendment 1 – October 29, 2019 o Minor changes: telephonic counseling schedule for Quit Card Intervention (QCI) participants • INITIATE Amendment 2 – February 3, 2020 o Minor change: Cellphone provided to study counselor to administer behavioral counseling to Quit Card Intervention (QCI) group • INITIATE Amendment 3 – February 24, 2020 o Minor change: make Baseline Case Report Form (CRF) a patient-facing document o Replaced SF-36 questionnaire with EQ-5D-QL survey tool to measure health-reported quality of life
Funding {4}	This trial is funded by the Canadian Institute of Health Research (CIHR), grant number PJT 162147
Author details {5a}	KAM1*, AG1, FG1, GW2,3 AK3,4, SH4,5, ALP1,3, KW1, VT3,4, MK1, RDR1,3 1Division of Cardiac Prevention and Rehabilitation, University of Ottawa Heart Institute 2Cardiovascular Research Methods Centre (CRMC), University of Ottawa Heart Institute (UOHI), Canada 3Faculty of Medicine, University of Ottawa, Canada 4Ottawa Hospital Research Institute (OHRI), Canada 5Institute for Clinical Evaluative Sciences (ICES), Ottawa, Canada *Corresponding author at: Division of Cardiac Prevention and Rehabilitation, Ottawa Heart Institute Research Corporation (OHIRC), 40 Ruskin Street, Ottawa, ON K1Y 4W7, Canada. E-mail address: kmullen@ottawaheart.ca (K.A. Mullen).
Name and contact information for the trial sponsor {5b}	This trial is investigator-led. The OHIRC will ensure standard operating procedures and quality assurance regarding the trial. Contact of OHIRC: researchservices@ottawaheart.ca
Role of sponsor {5c}	This is an investigator-led trial. The trial funder (Canadian Institutes of Health Research) does not have any role in the study design, data collection, or management.