1208 Participants Needed

Quit Card Intervention for Cigarette Addiction

(INITIATE Trial)

Recruiting at 4 trial locations
AG
EW
NP
CM
Overseen ByChantelle Masterson, BPhil
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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) and other high-volume hospital and community ambulatory care settings. 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, community healthcare centers, and other inpatient and outpatient clinics in Canada offer tobacco-use interventions. In order for clinicians to offer quit smoking support, interventions need to be simple given the realities of these high-volume environments. 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 and other high-volume hospital and community ambulatory care settings 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 environments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation, so it's best to discuss your medications with the study team or your doctor.

What data supports the effectiveness of the Quit Card Intervention treatment for cigarette addiction?

Research shows that personalized smoking cessation programs with extended support and follow-up can be effective, with quit rates approaching 20%. Additionally, combining brief interventions with motivational interviews and pharmacotherapy can improve cessation rates, suggesting that comprehensive approaches like the Quit Card Intervention may be beneficial.12345

Is the Quit Card Intervention for cigarette addiction safe for humans?

The safety of smoking cessation interventions, including behavioral therapies like counseling, is generally well-established. Nicotine patches and bupropion (a non-nicotine aid) have been studied extensively and are considered safe, even for patients with stable cardiovascular disease.16789

How is the Quit Card Intervention treatment different from other smoking cessation treatments?

The Quit Card Intervention (QCI) is unique because it may incorporate elements from tobacco quitlines (QLs), which provide counseling and support for quitting smoking. Unlike standard treatments that might focus solely on medication, QCI could involve personalized support and education, potentially making it more accessible and tailored to individual needs.710111213

Research Team

KM

Kerri-Anne Mullen, PhD

Principal Investigator

Ottawa Heart Institute Research Corporation

Eligibility Criteria

This trial is for daily smokers aged 18+ in Ontario who smoke at least 5 cigarettes a day, are not critically ill, and can follow up for two years. They must have health insurance, access to phone or computer, understand English or French, and be able to consent.

Inclusion Criteria

Able to provide informed consent
I am 18 years old or older.
You smoke at least 5 cigarettes every day.
See 5 more

Exclusion Criteria

I am in critical condition or in a psychiatric emergency.
Has morbid illness which will prevent completion of 26-week follow-up (e.g., receiving palliative care)
Currently participating in this or another smoking cessation study
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioural incentive and tailored follow-up support to increase long-term smoking abstinence

26 weeks
Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for smoking abstinence, health-related quality of life, and healthcare utilization

104 weeks
Follow-up assessments at 4, 26, 52, and 104 weeks

Treatment Details

Interventions

  • Quit Card Intervention (QCI)
Trial OverviewThe INITIATE Study tests a Quit Card Intervention (QCI) designed for emergency department settings. It aims to help smokers quit by combining behavioral incentives with tailored support over time while considering the fast-paced nature of EDs.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Quit Card Intervention (QCI)Experimental Treatment1 Intervention
Study intervention group.
Group II: Usual Care (UC)Active Control1 Intervention
Study control group.

Quit Card Intervention (QCI) is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Not applicable (behavioral intervention) for:
  • Smoking cessation support

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.
Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.
Tobacco cessation in primary care: maximizing intervention strategies.Anczak, JD., Nogler, RA.[2022]
The University of Ottawa Heart Institute implemented a comprehensive program that successfully identified and treated nearly 1300 smokers during their hospitalization for coronary artery disease, with 91% receiving cessation interventions.
Six months after hospitalization, 44% of participants were smoke-free, demonstrating that hospital stays can be a critical time to encourage smoking cessation when patients are most motivated to quit.
Promoting smoking cessation during hospitalization for coronary artery disease.Reid, RD., Pipe, AL., Quinlan, B.[2022]
The study found that an intensive intervention (II) combining brief advice, motivational interviews, and nicotine replacement therapy (NRT) led to a higher self-reported quit rate of 19.5% compared to 11.4% for the brief intervention (BI) alone, indicating that more comprehensive support can improve smoking cessation outcomes.
Despite the effectiveness of the II, there were significant challenges in its implementation, particularly in delivering motivational interviews and prescribing NRT, highlighting the need for practical strategies to enhance smoking cessation programs in hospital settings.
Smoking cessation interventions in the pre-admission clinic: assessing two approaches.Sachs, R., Wild, TC., Thomas, L., et al.[2018]

References

Tobacco cessation in primary care: maximizing intervention strategies. [2022]
Promoting smoking cessation during hospitalization for coronary artery disease. [2022]
Smoking cessation interventions in the pre-admission clinic: assessing two approaches. [2018]
Development and preliminary pilot evaluation of a brief tablet computer intervention to motivate tobacco quitline use among smokers in substance use treatment. [2018]
Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. [2023]
Efficacy and Safety of Smoking Cessation Interventions in Patients With Cardiovascular Disease: A Network Meta-Analysis of Randomized Controlled Trials. [2018]
Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. [2022]
Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]
Tobacco Smoking in Patients with Cardiovascular Disease. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. [2012]
Use of smoking reduction strategies among U.S. tobacco quitlines. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Association Between Utilization of Quitline Services and Probability of Tobacco Abstinence in Low-Income Smokers. [2022]
Cost-Effectiveness of a Health System-Based Smoking Cessation Program. [2022]