Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels
研究概览
简要总结
Children who are hospitalized are especially vulnerable to the effects of tobacco use and dependence among their caregivers, and they are more likely to be exposed than children who are not hospitalized. Hospitalization is an important teachable moment for health care providers to intervene with tobacco dependent parents, and help them reduce their child's exposure, potentially improving outcomes after hospitalization, and their future health. Understanding the best way to approach and intervene with these families will provide the investigator with the necessary information to create a sustainable intervention that can be disseminated to hospitals across the country that provide pediatric care, and to ultimately make a significant improvement in the health of children.
详细描述
This study is a randomized controlled trial (RCT) to determine whether the proposed bundled intervention is superior to usual care in the pediatric inpatient setting can decrease children's secondhand smoke exposure, and encourage their parents to make smoke-free home rules and quit smoking, as measured by a validated survey and biomarkers.
We have developed an intervention that bundles the best evidence for tobacco dependence treatment, including the United States Public Health Service (USPHS) guidelines, and evidence from parent-specific interventions, to create a sustainable, transferrable intervention specific to using the inpatient stay to help parents quit smoking and reduce their children's exposure. The intervention bundle includes screening for exposure, assessing readiness to quit, providing at least one brief motivational interviewing session in the hospital, dispensing nicotine replacement therapy if appropriate, providing a smoking cessation/reduction starter kit and arranging for follow up after the child is discharged.
INSPIRE specific aims:
Aim 1: To assess the efficacy of the intervention in increasing parent report of having smoke-free homes and cars 6 and 12 months after hospitalization
Aim 2: To demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels 6 and 12 months post-hospitalization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Families admitted to the inpatient units of Children's Hospital Colorado
- •Families with children <17 years of age
- •Families with at least one custodial parent smoker
排除标准
- •Admitted in the hospital < 24 hours
- •Families with children in foster care
- •Families with unclear custody of the child (i.e. children admitted with non-accidental trauma)
结局指标
主要结局
Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels
时间窗: 12 months after patient hospitalization
Measured by child urine cotinine levels
次要结局
- Child exposure prevalence(12 months after patient hospitalization)
- Child sick visits(12 months after patient hospitalization)
- Increased parent quit rates(12 months after patient hospitalization)
- Increased parent report of having smoke free homes and cars(12 months after patient hospitalization)