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临床试验/NCT01981564
NCT01981564已完成不适用

Asthma Express Intervention to Bridge Emergency to Primary Care for High Risk Children With Asthma

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 222 人开始时间: 2013年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
222
试验地点
2
主要终点
Symptom Days

研究概览

简要总结

Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.

详细描述

Asthma, the leading chronic disorder in childhood, is the number one cause of pediatric emergency department (ED) visits in young children and is responsible for a substantial impact on healthcare costs. The ED is often the point of contact for low-income children and many families view the ED as their primary source of asthma care. Poor and minority children have the highest asthma morbidity, are the least likely to receive adequate preventive therapy or specialty care and more frequently exposed to environmental triggers than non-poor children. However, prior studies, including our pilot, indicate that children with frequent asthma ED visits will attend a one-time ED-based follow-up clinic for an asthma "check-up" and education. The goal of this randomized controlled trial is to test the efficacy of a multifaceted, ED + primary care provider (PCP) and home-based intervention, Asthma Express (AEx), for children with > 2 asthma ED visits or 1 hospitalization/year that provides tailored guideline based asthma care. Allergy and cotinine biomarkers, collected during the ED visit, are used to target the home environmental control component of the intervention. The AEx intervention (n=132) will be compared to an attention control (CON) group (n=132) for the specific aims: (1) to reduce asthma morbidity (increase symptom free days and nights) and decrease ED visits and hospitalizations and increase asthma control and caregiver quality of life, (2) to improve the use of appropriate preventive anti-inflammatory medication based on child pharmacy refill records and (3) to compare the economic cost and effects of this intervention. Children aged 3-12 years with > 2 asthma ED visits or 1 hospitalization within the past 12 months and a current ED visit for asthma will be recruited from the Johns Hopkins Pediatric-ED and followed for 12 months. Symptom frequency, health care utilization, caregiver quality of life and cotinine measures will be collected at baseline, 6 and 12 months and pharmacy data collected at baseline and 12 months. Data analysis includes initial cross tabulations of health outcomes by group (AEx vs. CON) and multivariate generalized linear regression models to study the effects of the AEx treatment on mean symptom free days/nights, repeat ED visits, hospitalizations and caregiver quality of life scores and anti-inflammatory medication refills. Mean total costs of ED, PCP visits, hospital days and medication costs will be compared between groups (AEx and CON) for the economic analysis. The AEx model is designed to be accessible, guideline-based, easily replicated and incorporated into ED care. If successful, this study will fill critical gaps in the ED transition to preventive care asthma interventional research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • asthma diagnosis,
  • age 3 to 12 years,
  • two or more ED visits or one hospitalization for asthma within past 12 months, -working phone

排除标准

  • other respiratory chronic disease such as Cystic Fibrosis or Bronchopulmonary dysplasia

研究组 & 干预措施

Asthma Express Intervention

Experimental

Clinic visit for asthma education + nurse home visits

干预措施: Asthma Express Intervention (Behavioral)

Standard Asthma Education Control group

Active Comparator

Standard asthma education during nurse home visits

干预措施: Standard Asthma Education Control Group (Behavioral)

结局指标

主要结局

Symptom Days

时间窗: 3 months

Symptom days for asthma during past 14 days

次要结局

  • Emergency Department (ED) Visits for Asthma(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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