An Intervention to Reduce Second Hand Smoke Exposure Among Pediatric Emergency Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 770
- 试验地点
- 2
- 主要终点
- Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
研究概览
简要总结
This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure-related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment (SBIRT); or 2) Healthy Habits Control (HHC). The Screening, Brief Intervention, and Assisted Referral to Treatment condition will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve the child's health.
详细描述
This study will test the efficacy of a cessation intervention for caregivers in a large, inner-city Pediatric Emergency Department. The proposed Screening, Brief Intervention, and Assisted Referral to Treatment will highlight the effects of Second Hand Smoke exposure on the child's health. the investigators will randomize 750 caregivers who smoke who present to our Pediatric Emergency Department with their child who has a Second Hand Smoke exposure related illness to either one of two conditions: 1) Screening, Brief Intervention, and Assisted Referral to Treatment; or 2) Healthy Habits Control. The Screening, Brief Intervention, and Assisted Referral to Treatment condition will use components shown to be effective in the out-patient setting but not yet tested in the Pediatric Emergency Department setting. It will include a brief form of the Clinical Practice Guideline: Treating Tobacco Use and Dependence, motivational interviewing, engaging and personalized materials on the effects of smoking and Second Hand Smoke exposure, immediate access to caregivers' choice of cessation resources (e.g., Quitline, smokefree.gov, or txt2quit), a 12-week supply of nicotine replacement therapy and weekly booster materials for 12 weeks. The Healthy Habits Control program has been previously developed and used in the out-patient setting, and will be used as an attention control in which caregivers will receive instruction on healthy lifestyle choices to improve their child's health. Cessation assistance will be offered at the study's conclusion. If effective, the Screening, Brief Intervention, and Assisted Referral to Treatment model could be routinely used in the Pediatric Emergency Department setting, which could reach at least one million smokers a year, and could result in significant reductions in caregivers' tobacco use, Second Hand Smoke exposure related pediatric illness, and costs in this population. In addition, the investigators' results will inform the conduct of public health research efforts aimed at adults via the Pediatric Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible participants must:
- •be > age 18;
- •be accompanying a child 0-17 years of age who is presenting to the Pediatric Emergency Department with:
- •a stable condition, that is, patients who are not critically ill and do not require immediate treatment and intervention by the Pediatric Emergency Department practitioner and
- •a potentially Second Hand Smoke exposure related chief complaint (such as wheezing, difficulty breathing, cough) as outlined by the U.S. Surgeon General;45
- •be a daily smoker;
- •have currently or recently smoked inside their home;
- •speak and read English, and
- •have a permanent address and a working cell or landline number.
- •Live within a 50 mile radius.
- •Child is a non-smoker.
排除标准
- •Caregivers will be excluded if
- •their child has a tracheostomy or
- •if the caregivers are tobacco chewers only,
- •if the caregivers are using pharmacologic cessation treatment,
- •or plan to move within the study period.
结局指标
主要结局
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Months
时间窗: 6months post enrollment
Primary outcomes are self-reported prolonged abstinence at 6 months post-enrollment, validated in all participants via salivary cotinine levels.
Percentage of Participants With Self-reported Prolonged Abstinence at 6 Weeks
时间窗: 6 weeks post enrollment
Primary outcomes are self-reported prolonged abstinence at 6-weeks post-enrollment, validated in all participants via salivary cotinine levels.
次要结局
- Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Weeks(baseline and 6 weeks post enrollment)
- Change From Baseline in the Number of Cigarettes Smoked Per Day at 6 Months(baseline and 6 months post enrollment)
- Readiness to Quit at 6 Weeks(6 weeks post enrollment)
- Number of Quit Attempts at 6 Weeks(6 weeks post enrollment)
- Number of Quit Attempts at 6 Months(6 months post enrollment)
- Readiness to Quit at 6 Months(6 months post enrollment)
- Use of Cessation Resources at 6 Months(6 months post enrollment)
- Use of Cessation Resources at 6 Weeks(6 weeks post enrollment)