Application of a Brief Digital Screening Tool to Address Parental and Adolescent Tobacco and Electronic Cigarette Use in Pediatric Medical Care (CanCEASE) - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention
研究概览
简要总结
Tobacco use is the single greatest preventable cause of morbidity and mortality in Canada, accounting for 48,000 deaths and $16.2 billion annually in attributable health-related costs. Parents who smoke are often medically underserved and visit their child's doctor more than their own; 25% of all adult smokers have children seen in child healthcare. When parents quit smoking, their life expectancy is increased by more than 10 years, tobacco-related poor pregnancy outcomes are eliminated, children's risk of becoming smokers decreases 4-fold, families have more money for necessities, and children are less likely to suffer from diseases caused by tobacco smoke exposure.
Despite free tobacco cessation services in every province and widespread insurance coverage of NRT, parental tobacco screening and cessation support rarely happens in pediatric care, thus there is potential for major health benefits from a routinely delivered tobacco control program to parents in this setting.
The investigators will conduct a 12-month single centre, pragmatic, single-blind pilot RCT of CEASE vs. usual care of 70 parents who use cigarettes and/or vaping products whose children are seen in pediatric clinics at the CHU Sainte-Justine. A similar trial, CEASE-A will be conducted with 70 adolescents ages 14-17.
Objectives:
- Perform a pilot RCT of the Clinical Effort Against Secondhand Smoke (CEASE) intervention in Canada. CEASE is an evidence-based parental smoking cessation intervention to ensure that every parent who uses cigarettes and/or nicotine vaping products and visits their child's pediatrician receives nicotine dependence treatment
- Conduct an ancillary pilot RCT of CEASE-A to deliver evidence-based support for adolescents who use tobacco and/or nicotine vaping products Outcomes include pilot process outcomes and preliminary effectiveness outcomes to assess feasibility and inform the preparation of a future large-scale RCT.
This pilot RCT will provide the data necessary to plan a fully powered RCT assessing the effectiveness of CEASE and CEASE-A for smoking and vaping cessation.
详细描述
Background: Tobacco use is the single greatest preventable cause of morbidity and mortality in Canada, accounting for 48,000 deaths and $16.2 billion in attributable health-related costs annually. Twenty-five percent of all adult smokers have children who are seen in child healthcare offices. When parents quit smoking, their life expectancy is increased by more than 10 years, tobacco-related poor pregnancy outcomes are eliminated, children have 4-fold lower risk of becoming smokers, families have more money for necessities, and children are less likely to suffer from diseases caused by tobacco smoke exposure. Parents who smoke are often medically underserved and visit their child's doctor more than their own. Thus, a routinely delivered tobacco control program to parents in the pediatric context would provide a major health benefit to the nation. Yet, parental tobacco screening and cessation support happens less than 5% of the time in pediatric practices despite free tobacco cessation quitlines and services in every province and widespread insurance coverage of nicotine replacement therapy (NRT).
Specific Objectives:
Primary objective:
• Perform a pilot randomized controlled trial (RCT) of the Clinical Effort Against Secondhand Smoke (CEASE) intervention in Canada. CEASE is an evidence-based parental smoking cessation intervention to ensure that every parent who uses cigarettes and/or nicotine vaping products and visits their child's pediatrician receives nicotine dependence treatment.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
盲法说明
Investigators will be blinded to the participants' group allocation. In this pragmatic trial, pediatricians may decide to discuss smoking and/or vaping with families as part of their usual care, and participants may mention the CEASE/CEASE-A intervention during the encounter with the provider. As such, participants and physicians will not be blinded.
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents or legal guardians of children 0-17 years old and who smoke or use nicotine vaping products. "User" will be defined as those who answer "Yes" to the screening questions:
- •"Have you smoked a single cigarette, even a puff, in the past 7 days?" (smoking);
- •"Have you used an e-cigarette or vaping device containing nicotine, even a puff, in the past 7 days? (vaping).
- •For CEASE-A, adolescent patients aged 14-17 years who smoke or use nicotine vaping products will be considered. "Adolescent User" will be defined by those who answer "Yes" to the same screening question as parents.
- •Parents will be eligible if 1) they are at least 18 years old, 2) their child is 0-17 years of age, 3) are attending a regular scheduled medical appointment, and 4) are sufficiently proficient in either French or English (able to read and answer a written questionnaire).
- •Adolescents will be eligible if they are 14-17 years-old, meet criteria 3) and 4) above, and have provided informed consent (in Québec, adolescents aged 14 years can provide consent). Adolescents whose parent(s) (if present) are not agreeable to their participation will be excluded.
排除标准
- •Families presenting to the clinic without a scheduled medical appointment will be excluded. There will be no other exclusion criteria.
结局指标
主要结局
Feasibility of the intervention
时间窗: 12 months of study follow up.
Proportion of eligible participants in each category (parents and adolescents) who declare interest in smoking/vaping cessation, who wish to be connected with smoking/vaping cessation services (quitlines), and who want to receive NRT.
Study retention and completion of follow-up questionnaires
时间窗: 6 months of participant follow up.
Proportion of participant that drop out or are lost to follow-up at 1, 3 and 6 months * Availability of self-reported smoking/vaping status at 1-, 3- and 6-month * Complete data available (1-, 3- and 6-month surveys) for retained participants * Availability of cotinine-testing at 1-, 3- and 6 months
Abstinence at 6 months
时间窗: 6 months of participant follow up.
% of parental/adolescent users who report 7-day abstinence at 6-month follow-up. We will collect self-reported smoking and vaping status using the validated single items "Have you smoked a single cigarette, even a puff, in the past 7 days?" and "Have you used a nicotine vaping product, even a puff, in the past 7 days?"
Parental and adolescent recruitment rates
时间窗: 12 months of study follow up
The proportion of eligible participants approached who are enrolled in the study. Number of participants recruited per month.
Protocol fidelity
时间窗: 6 months of participant follow up.
Proportion of participants who complete the baseline questionnaire, proportion of participants who want to be connected to quitlines who are referred, and proportion who want to receive NRT and receive a prescription.
Cotinine-confirmed quit
时间窗: 6 months of participant follow up.
Participants who self-report 7-day abstinence at 1, 3 and/or 6 months will receive a sampling kit by mail along with instructions on how to collect the urine for biochemical confirmation of smoking/vaping cessation
次要结局
- Proportion of participants reporting intent to quit smoking/vaping(6 months of participant follow-up)
- Proportion of participant reporting quit attempts at 1-, 3- and 6- months(6 months of participant follow-up)
研究者
Olivier Drouin, M.D., M.Sc M.P.H.
Pediatrician and Clinical Assistant Professor, Departments of Paediatrics and Department of Social and Preventive Medicine
St. Justine's Hospital