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

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). 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 in Canada offer tobacco-use interventions. In order for ED staff to offer quit smoking support, interventions need to be simple given the realities of the ED environment. 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 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 ED environments.

Study Overview

• Status: Active, not recruiting
• Conditions: Nicotine Dependence, Cigarettes; Nicotine Withdrawal
• Intervention / Treatment: Behavioral: Quit Card Intervention (QCI)

• Study Type: Interventional
• Enrollment (Estimated): 1208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evyanne Wooding, R.Kin; Phone Number: 17596 613-696-7000; Email: ewooding@ottawaheart.ca
• Study Contact Backup: Name: Nia Patel, MSc; Phone Number: 17595 613-696-7000; Email: niapatel@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital General Campus
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital Civic Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Current daily smoker (smokes ≥ 5 cigarettes per day);
• ≥ 18 years of age (the age of majority in Ontario);
• 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 24 months;
• Has access to a telephone or computer;
• Able to provide informed consent

Exclusion Criteria:

• Currently participating in this or another smoking cessation study;
• 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 2 years, or breastfeeding;
• Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care);
• In the opinion of the ED physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quit Card Intervention (QCI); Study intervention group.	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.
No Intervention: Usual Care (UC); Study control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Abstinence	Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test	26 weeks (6 months) after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolonged Abstinence	Prolonged (since last time point) smoking abstinence, at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Point Prevalence Abstinence	Point prevalence smoking abstinence, at 4, 52 and 104 weeks	4, 52 and 104 weeks after study enrollment
Smoking Reduction	Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Number of Quit Attempts	Number of quit attempts since study entry, at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Cessation Medication and/or E-cigarette Use	Use of smoking cessation medication and/or e-cigarette, at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Use of Behavioural Supports	Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Health-Related Quality of Life	Health-related quality of life (HR-QoL), at 52 and 104 weeks. This will be measured using the 36-Item Short Form Health Survey (SF-36), where each item is scored so that the lowest and highest possible scores are 0 and 100 respectively, and a high score outlines a more favorable state of health.	52 and 104 weeks after study enrollment
Health Services Outcomes - ED visits	Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Health Services Outcomes - Hospital Admissions	Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Health Services Outcomes - Deaths	Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, 52 and 104 weeks	4, 26, 52 and 104 weeks after study enrollment
Cost-Effectiveness Ratios	Cost-effectiveness ratios related to health services at 52 and 104 weeks	52 and 104 weeks after study enrollment

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Kerri-Anne Mullen, PhD, Ottawa Heart Institute Research Corporation

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: October 7, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department; Nicotine Dependence; Cigarette; Nicotine Replacement Therapy; Tobacco Abstinence; Tobacco Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Disease Attributes; Emergencies; Tobacco Use Disorder
• Other Study ID Numbers: 20190485-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No