West Philadelphia Asthma Care Implementation Plan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 626
- 试验地点
- 2
- 主要终点
- Change in Asthma Control
研究概览
简要总结
This project uses community health workers (CHW) or lay health educators to implement asthma interventions that have been proven to work in the primary care setting and in schools. The objective is to integrate the home, school, healthcare system, and community for 600 school-aged asthmatic children in West Philadelphia through use of CHWs.
The children enrolled in the study will be randomized to one of four groups including: primary care CHW, school CHW, primary care and school CHW or the control group (no CHW).
详细描述
The Community Asthma Prevention Program (CAPP) at the Children's Hospital of Philadelphia has a two-decade history of utilizing CHWs to improve asthma outcomes of children in Philadelphia. Building on this foundation, a network of stakeholders was established including, The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from public housing, healthcare, community, and schools. As a result of assessment of local needs, resource mapping, and months of planning, Investigators designed an asthma care implementation program with the broad objective of integrating home, school, healthcare system, and community for school-aged asthmatic children in West Philadelphia. Investigators seek to accomplish this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. The evidence-based interventions include (1) a primary care-based Yes We Can intervention with home visitation and (2) a comprehensive and rigorously evaluated school-based intervention, Open Airways for schools and School Based Asthma Therapy. CHWs will function as the hub of each interventions, serving either as primary care CHWs or school CHWs to provide a network of education, care coordination support, and to facilitate communication for families of children with asthma between the four sectors. This project seeks to integrate interventions in a comprehensive and sustainable manner to reduce asthma disparities in poor, minority children.
Using a factorial design, Investigators will recruit and randomize 640 asthmatic children (ages 5-13 years) from up to five inner-city primary care clinics who attend one of 36 West Philadelphia schools to one of four study conditions: both interventions (both primary care and school CHWs intervention), primary care CHW or school-CHW alone, or control and follow for one year. As a part of this project the Investigators seek to accomplish the following objectives:
Objective 1. Compare effectiveness of the primary care and school interventions to improve asthma control and reduce symptom days using main and simple effects from the factorial design.
Objective 2. Explore moderators and mechanisms of effectiveness and sustainability of the interventions.
Objective 3. Use mixed methods to explore implementation determinants and outcomes of school intervention that promote effectiveness, fidelity and sustainability
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
- Single (Investigator)
盲法说明
The Principal Investigator (PI) will be masked to the participant-level intervention group. Unmasking will occur if there is an adverse event that warrants investigation or if the Data Safety and Monitoring Board (DSMB) instructs the PI to become unmasked.
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 5-13 years of age and their parents/guardians
- •Children with a diagnosis of asthma
- •Children with uncontrolled asthma (as evidenced within the previous 12 months by an asthma exacerbation requiring oral steroids -OR- an Emergency Department (ED) visit for asthma -OR- an inpatient admission for asthma)
- •West Philadelphia residence in zip code 19104, 19131, 19139, 19142, 19143, 19151 or 19153
- •Children in grades K-8
- •Pediatric primary care received at Children's Hospital of Philadelphia Care Network (CN) Karabots, Cobbs Creek, or South Philadelphia locations or pediatric care received at the Pediatric and Adolescent Medicine Centers of Philadelphia (PAMCOP) serving West Philadelphia residents
- •Parental/guardian permission (informed consent) and, if appropriate, child assent
- •English Language Speaking
排除标准
- •Subjects with other chronic respiratory illnesses such as cystic fibrosis
- •Cyanotic congenital heart disease
- •Mental retardation and/or cerebral palsy (MRCP)
- •Severe Neurological Disorder
- •Cyanotic congenital heart disease
- •Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
结局指标
主要结局
Change in Asthma Control
时间窗: Baseline and 12 months
Asthma Control Questionnaire (ACQ) developed by E.F. Juniper et al. is a 6-item recall of asthma control indicators over the past week. The 6-item recall includes awakening at night with asthma symptoms, asthma symptoms upon waking, activity limitations due to asthma symptoms, shortness of breath, wheezing, and administration of asthma rescue medications. The score range for the ACQ is 0 to 6, with lower numbers indicating greater asthma control and higher numbers indicating worse asthma control. Based on existing literature, the minimal clinically important difference (MCID) is 0.5. The range for this cohort is 0.2-2.3) For all analyses, we combined the P+S- group with the P+S0 group to describe the P+ only group. Similarly, we combined the P-S- group with the P-S0 group to create the control group.
次要结局
- Change in Daytime Asthma Symptoms(Baseline and 12 months)
- Change in Nighttime Symptoms(Baseline and 12 months)
- Change in School Absences(Baseline and 12 months)
- Change in Emergency Department (ED) Visits(Baseline and 12 months)
- Change in Hospitalizations(Baseline and 12 months)
- Change in Asthma Emotional Functioning Domain(Baseline and 12 months)
- Change in Activity Limitations Domain(Baseline and 12 months)
- Baseline School Organizational Climate Index(At start of school intervention)
- Baseline School Leadership(At start of school intervention)
- Baseline School Staff Attitudes(At start of school intervention)