Initiation of Chronic Asthma Care Regimens in the Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- ED and primary care provider utilization
研究概览
简要总结
Hypothesis: Initiating chronic management treatment plans in conjunction with an asthma educational intervention in the pediatric Emergency Department (ED) with anti-inflammatory medication will result in an improvement of ED revisits (and unscheduled return visits). Chronic management intitiation in conjunction with an asthma educational intervention in the pediatric ED with anti-inflammatory medication will also result in improved Quality of Life measure.
Specific aims: 1. To demonstrate that the initiation controller medication therapy in conjunction with asthma education will result in:
-
Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period
-
Improved Quality of Life as measured by Bukstein's ITG Quality of Life measure.
-
To describe the relationship of the initiation of controller medication therapy in conjunction with asthma education with well child visits, missed school/daycare days and behavioral capabilities.
Objective: To determine the impact of beginning chronic asthma medication regimens after an educational intervention in the ED in pediatric patients 1-18 years of age with mild to moderate persistent asthma.
Long-term goal/purpose: To demonstrate the success of a model of care that utilizes the emergency department physician to initiate National Asthma Education and Prevention Program (NAEPP) guided chronic asthma therapy in children 1-18 years of age. This model will attempt to bridge the gap in initiation of chronic asthma therapy currently left by a failure of both emergency department and primary care physicians.
详细描述
This study is a health outcomes intervention trial that utilizes a randomized clinical trial (non-placebo controlled) with two separate arms. The study will be conducted in the ED of Texas Children's Hospital, a tertiary care facility that evaluates over 80,000 children per year. IRB approval has been obtained, and guardians of patients 1-18 years of age will be consented for enrollment. All children will receive standardized burst steroids and broncholdilators (albuterol), however, patients will be randomized to a control and intervention group. Randomization will occur utilizing assignment by a randomized number table. The randomization scheme will then be packaged into sealed envelopes concealed to the educational interventionist at the time of enrollment. Once the patient is enrolled, the interventionist will open the sealed envelope revealing assignment to intervention or control. The study will utilize a post hoc analysis of age subgroups (1 through 5 years of age and 6 through 18 years of age).
Inclusion Criteria:
The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.
Exclusion Criteria:
Patients without a physician's confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
盲法说明
patients will be randomized to a control and intervention group. Randomization will occur utilizing assignment by a randomized number table. The randomization scheme will then be packaged into sealed envelopes concealed to the educational interventionist at the time of enrollment. Once the patient is enrolled, the interventionist will open the sealed envelope revealing assignment to intervention or control.
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The enrollees involved must be a child who is 1-18 years of age, with a diagnosis of persistent asthma or reactive airway disease and no other cardiovascular or pulmonary disease not currently on the NAEPP recommended chronic care regimen for controller medication therapy.
排除标准
- •Patients without a physician's confirmed diagnosis of asthma. Children with concurrent cardiovascular or pulmonary disease. Patients will also be excluded if they do not speak English or Spanish as their primary language.
结局指标
主要结局
ED and primary care provider utilization
时间窗: 12 months
Decreased return ED visits (or unscheduled primary care physician visits) as compared to a control group over a 12 month period will be measured by comparisons of total number of ED visits (and unscheduled PCP visits) in each group
次要结局
- Improved Quality of Life as measured by Bukstein's ITG will utilize the scoring system developed by Bukstein to evaluate individual parameters as well as aggregate scores in the control and intervention group at each of the 3 month intervals. Significan(Measured at 3, 9, and 12 months)
研究者
Andrea Cruz
Associate Professor
Baylor College of Medicine