Clinical trial NCT04163081: The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Official title: The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Nicotine Withdrawal
Keywords: Nicotine Replacement Therapy
Emergency Department
Nicotine Dependence
Tobacco Abstinence
Tobacco Treatment
Cigarette
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-11-14
Enrollment: 1208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) 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.


Eligibility criteria: Inclusion Criteria:

* Current daily smoker (smokes ≥ 5 cigarettes per day);
* ≥ 18 years of age (the age of majority in Ontario);
* For ED sites only, 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;
* For ED sites only, 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 attending physician, manifests acute physical and/or psychiatric illness or has cognitive impairment that would preclude participation in/benefit from the intervention.
* Scheduled for a known elected surgery, procedure, or future hospitalization during the study period.

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 26 weeks (6 months) after study enrollment
Secondary outcomes:
measure: Prolonged Abstinence
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Point Prevalence Abstinence
timeFrame: 4, 52 and 104 weeks after study enrollment
measure: Smoking Reduction
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Number of Quit Attempts
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Cessation Medication and/or E-cigarette Use
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Use of Behavioural Supports
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Health-Related Quality of Life
timeFrame: 52 and 104 weeks after study enrollment
measure: Health Services Outcomes - ED visits
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Health Services Outcomes - Hospital Admissions
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Health Services Outcomes - Deaths
timeFrame: 4, 26, 52 and 104 weeks after study enrollment
measure: Cost-Effectiveness Ratios
timeFrame: 52 and 104 weeks after study enrollment
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ont'
city: Ottawa
country: Canada
facility: Civic Hospital
state: Ontario
city: Ottawa
country: Canada
facility: General Hospital
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Kerri-Anne Mullen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.