Optimizing Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
研究概览
简要总结
Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma.
This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.
详细描述
Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life.
Specific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 - 12 years of age
- •child has asthma diagnosed by a doctor based on parental/caregiver report
- •child is not already properly using an ICS or being discharged with an ICS
排除标准
- •The child has previously participated in this study
- •The child has major co-morbid disease of the heart or lungs (examples include cystic fibrosis, heart disease, muscular dystrophy and cerebral palsy with immobility. It does not include allergic rhinitis or a history of respiratory infections such as pneumonia or bronchiolitis.
- •The child's parents/caregivers do not speak English
- •The child is not going to be discharged from the emergency department (e.g. hospitalization)
研究组 & 干预措施
Inhaled corticosteroid (fluticasone)
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
干预措施: fluticasone (Drug)
Inhaled corticosteroid (fluticasone)
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
干预措施: Standard Asthma Discharge Instructions (Other)
Routine Asthma Care
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
干预措施: Standard Asthma Discharge Instructions (Other)
结局指标
主要结局
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
时间窗: 6 months
The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.
次要结局
- Primary Care Visits for Well Checks(6 months)
- ED Visits for Asthma(6 months)
- Hospitalizations for Asthma(6 months)
- Unscheduled Primary Care Visits(6 months)
- Oral Steroid Courses(6 months)