Quit Card Intervention for Cigarette Addiction

(INITIATE Trial)

Recruiting at 4 trial locations

Overseen By Chantelle Masterson, BPhil

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Pregnant, Morbid illness, Acute illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

1208 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{7 10 11 12 13}

Research Team

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.

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

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 Overview The 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

Group I: Quit Card Intervention (QCI) Experimental Treatment 1 Intervention

Study intervention group.

Group II: Usual Care (UC) Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in the pre-admission clinic: assessing two approaches. Sachs, R., Wild, TC., Thomas, L., et al.[2018]

The TIME-TQ intervention, developed for smokers in substance use disorder treatment, received positive feedback and significantly increased participants' readiness to quit smoking and their perceived importance of quitting.

Despite the initial motivation to quit, the standard referral method to quitline services was ineffective, as only three participants received counseling and none achieved sustained abstinence, highlighting the need for improved referral strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and preliminary pilot evaluation of a brief tablet computer intervention to motivate tobacco quitline use among smokers in substance use treatment. Brown, RA., Hecht, J., Bloom, EL., et al.[2018]

Clinicians can significantly reduce cardiovascular risks by actively helping patients quit smoking, which includes documenting smoking status and providing strong advice to quit at every visit.

Effective pharmacotherapies like nicotine replacement, bupropion, and varenicline can double the chances of quitting, but comprehensive support such as behavioral counseling and follow-up is often lacking, highlighting the need for referrals to specialized quitlines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. Nides, M., Leischow, S., Sarna, L., et al.[2023]

Varenicline and bupropion are effective smoking cessation aids for patients with cardiovascular disease, showing significantly higher abstinence rates compared to placebo in a meta-analysis of 7 pharmacotherapy trials involving 2809 participants.

Behavioral interventions, particularly individual counseling and telephone therapy, also demonstrate efficacy in promoting smoking cessation among CVD patients, outperforming usual care in a review of 17 trials with 4666 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Smoking Cessation Interventions in Patients With Cardiovascular Disease: A Network Meta-Analysis of Randomized Controlled Trials. Suissa, K., Larivière, J., Eisenberg, MJ., et al.[2018]

An intensive smoking cessation intervention for cardiac patients, involving bedside counseling and follow-up calls, resulted in a 62% abstinence rate at 12 months, compared to 46% in a minimal intervention group, indicating that more comprehensive support significantly improves quitting success.

Patients who underwent coronary artery bypass grafting (CABG) had higher rates of continuous abstinence (57%) compared to those admitted for acute myocardial infarction (39%), suggesting that the type of cardiac event may influence the effectiveness of smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. Smith, PM., Burgess, E.[2022]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

Quitting smoking significantly lowers the risk of cardiovascular events, and most patients with cardiovascular disease (CVD) want to stop smoking, making effective interventions crucial.

Combining behavioral counseling with pharmacologic treatments, like nicotine patches and bupropion, can greatly enhance long-term cessation rates in CVD patients, and creating supportive clinical environments can further improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Smoking in Patients with Cardiovascular Disease. Joseph, AM., An, LC.[2022]

The Refer2Quit (R2Q) online training program significantly increased fax referral rates to tobacco quitlines among healthcare providers, with an odds ratio of 2.86, indicating a strong improvement in referral practices after training.

Providers who completed the R2Q training reported enhanced self-efficacy and more positive attitudes towards delivering tobacco cessation interventions, although barriers like lack of reimbursement and patient reluctance still hindered referral rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. Carpenter, KM., Carlini, BH., Painter, I., et al.[2012]

A survey of 14 tobacco quitline service providers across all 50 US states revealed that while all recommended setting a new quit date for smokers who missed their target quit date, only 6% used motivational interviewing techniques to encourage this.

The majority of quitlines (90%) focused on interventions aimed at reducing smoking rates rather than directly promoting complete cessation, indicating a need for further research to assess the effectiveness of these reduction strategies in improving overall smoking abstinence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smoking reduction strategies among U.S. tobacco quitlines. Asfar, T., Ebbert, JO., Klesges, RC., et al.[2018]

In a study of 778 low-income smokers, those who used quitline (QL) services showed higher smoking cessation rates, with 15.3% abstinence in high QL users compared to only 7.2% in non-users.

The findings suggest a positive relationship between the frequency of QL service use and tobacco abstinence, indicating that greater engagement with these services may enhance quit rates among low-income smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Quitline Services and Probability of Tobacco Abstinence in Low-Income Smokers. Bernstein, SL., Weiss, JM., Toll, B., et al.[2022]

The Project CLIQ program, which connects low- to moderate-income smokers with cessation resources, was found to be cost-effective, costing about $33 per smoker and $4137 per additional quit over a 20-month period with 707 participants from a pool of 8544 smokers.

The cost-effectiveness of CLIQ improves significantly with higher participation rates and larger populations of smokers, making it a promising strategy for health systems aiming to reduce smoking rates among low-income communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of a Health System-Based Smoking Cessation Program. Levy, DE., Klinger, EV., Linder, JA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Promoting smoking cessation during hospitalization for coronary artery disease. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Smoking cessation interventions in the pre-admission clinic: assessing two approaches. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Development and preliminary pilot evaluation of a brief tablet computer intervention to motivate tobacco quitline use among smokers in substance use treatment. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Maximizing smoking cessation in clinical practice: pharmacologic and behavioral interventions. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Smoking Cessation Interventions in Patients With Cardiovascular Disease: A Network Meta-Analysis of Randomized Controlled Trials. [2018]

7. Canada pubmed.ncbi.nlm.nih.gov

Smoking cessation initiated during hospital stay for patients with coronary artery disease: a randomized controlled trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Tobacco Smoking in Patients with Cardiovascular Disease. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Refer2Quit: impact of Web-based skills training on tobacco interventions and quitline referrals. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Use of smoking reduction strategies among U.S. tobacco quitlines. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Association Between Utilization of Quitline Services and Probability of Tobacco Abstinence in Low-Income Smokers. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of a Health System-Based Smoking Cessation Program. [2022]