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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163081
Recruitment Status : Active, not recruiting
First Posted : November 14, 2019
Last Update Posted : January 17, 2024
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence, Cigarettes Nicotine Withdrawal Behavioral: Quit Card Intervention (QCI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Actual Study Start Date : April 19, 2022
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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.



Primary Outcome Measures :
  1. Smoking Abstinence [ Time Frame: 26 weeks (6 months) after study enrollment ]
    Smoking abstinence at 26 weeks, biochemically verified using an expired air carbon monoxide (CO) test


Secondary Outcome Measures :
  1. Prolonged Abstinence [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Prolonged (since last time point) smoking abstinence, at 4, 26, 52 and 104 weeks

  2. Point Prevalence Abstinence [ Time Frame: 4, 52 and 104 weeks after study enrollment ]
    Point prevalence smoking abstinence, at 4, 52 and 104 weeks

  3. Smoking Reduction [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Smoking reduction (i.e., change in number of daily cigarettes), at 4, 26, 52 and 104 weeks

  4. Number of Quit Attempts [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Number of quit attempts since study entry, at 4, 26, 52 and 104 weeks

  5. Cessation Medication and/or E-cigarette Use [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Use of smoking cessation medication and/or e-cigarette, at 4, 26, 52 and 104 weeks

  6. Use of Behavioural Supports [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Use of behavioural supports (e.g., counseling, quit lines), at 4, 26, 52 and 104 weeks

  7. Health-Related Quality of Life [ Time Frame: 52 and 104 weeks after study enrollment ]
    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.

  8. Health Services Outcomes - ED visits [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) visits to ED at 4, 26, 52 and 104 weeks

  9. Health Services Outcomes - Hospital Admissions [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) admissions to hospital at 4, 26, 52 and 104 weeks

  10. Health Services Outcomes - Deaths [ Time Frame: 4, 26, 52 and 104 weeks after study enrollment ]
    Number of all-cause and smoking-related (e.g., vascular, respiratory, cancer-related) deaths at 4, 26, 52 and 104 weeks

  11. Cost-Effectiveness Ratios [ Time Frame: 52 and 104 weeks after study enrollment ]
    Cost-effectiveness ratios related to health services at 52 and 104 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163081


Locations
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Canada, Ontario
The Ottawa Hospital General Campus
Ottawa, Ontario, Canada, K1H 8L6
The Ottawa Hospital Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Kerri-Anne Mullen, PhD Ottawa Heart Institute Research Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT04163081    
Other Study ID Numbers: 20190485-01H
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: January 17, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Heart Institute Research Corporation:
Nicotine Replacement Therapy
Emergency Department
Nicotine Dependence
Tobacco Abstinence
Tobacco Treatment
Cigarette
Additional relevant MeSH terms:
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Emergencies
Tobacco Use Disorder
Disease Attributes
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders