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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Smoking Abstinence [Срок оценки: 26 weeks (6 months) after study enrollment]

Вторичные конечные точки (11)

• Prolonged Abstinence [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Point Prevalence Abstinence [Срок оценки: 4, and 52 weeks after study enrollment]
• Smoking Reduction [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Number of Quit Attempts [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Cessation Medication and/or E-cigarette Use [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Use of Behavioural Supports [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Health-Related Quality of Life [Срок оценки: 52 weeks after study enrollment]
• Health Services Outcomes - ED visits [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Health Services Outcomes - Hospital Admissions [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Health Services Outcomes - Deaths [Срок оценки: 4, 26, and 52 weeks after study enrollment]
• Cost-Effectiveness Ratios [Срок оценки: 52 weeks after study enrollment]

Критерии участия

Критерии включения

• 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 12 months;
• Has access to a telephone or computer;
• Able to provide informed consent

Критерии исключения

• 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 year, 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 4 центра

• Civic Hospital — Ottawa
• General Hospital — Ottawa
• Riverside Hospital — Ottawa
• University of Ottawa Heart Institute — Ottawa

Публикации

• 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. PMID 34688291

Идентификаторы

NCT: NCT04163081 · 20190485-01H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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