Improving Asthma Outcomes in a High Morbidity Urban Pediatric Population: an Emergency Department-based Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 488
- 试验地点
- 2
- 主要终点
- Unscheduled visits for asthma
研究概览
简要总结
Little is known about how ED-based programs can help to reduce pediatric ED visits for asthma. The current study evaluated a novel intervention in which the ED itself became the site of highly individualized, comprehensive follow-up asthma care. It sought to determine if such an intervention could decrease subsequent unscheduled visits for asthma while improving asthma quality of life.
详细描述
Prospective, randomized clinical trial of a single visit to a specialized emergency department-based asthma follow-up clinic occurring 2-15 days after emergency department care for an acute exacerbation. All patients were followed for 6 months. Analysis was by intention-to-treat with adjustment for baseline differences. Our primary hypothesis was that this intervention would decrease subsequent unscheduled visits (both to EDs and other sources of urgent care) for asthma over a six-month follow-up period. We further hypothesized that the intervention would decrease hospitalizations for asthma, improve compliance with an individualized medical plan and with trigger control, increase scheduled primary care practitioner (PCP) visits for routine asthma care, and decrease asthma symptoms while improving asthma quality of life (QOL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 12 months and 17 years, inclusive;
- •prior physician-diagnosed asthma;
- •≥1 other unscheduled visit for asthma in the previous 6 months and/or ≥1 hospitalization for asthma in the prior 12 months;
- •a parent/guardian available for interview;
- •residence in Washington, DC or a contiguous Maryland county; and
- •requirement for ≥3 doses of nebulized albuterol in the ED at the time of enrollment.
排除标准
- •significant medical co-morbidities affecting the cardiorespiratory system;
- •a visit to an allergist or a pulmonologist in the prior 6 months;
- •≥2 of the following: a current written asthma medical action plan, current use of >1 controller medication, or a scheduled visit for asthma care with their PCP in the prior two weeks;
- •enrollment in another asthma research study;
- •unavailability for telephone follow-up; or
- •primary language other than English or Spanish.
结局指标
主要结局
Unscheduled visits for asthma
时间窗: 6 months following enrollment
次要结局
- Hospitalizations for asthma(6 months following enrollment)
- Quality of Life(6 months following enrollment)
- Morbidity(6 months following enrollment)
- Compliance(6 months following enrollment)
研究者
Stephen J. Teach, MD, MPH
MD
Children's National Research Institute