Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
研究概览
简要总结
The overall goal of this research study is to test the effectiveness of a multifaceted and multi-level prompting intervention in a real world urban primary care office setting on improving provider-delivered guideline-based asthma care and reducing asthma morbidity among urban children with persistent or uncontrolled asthma.
详细描述
Investigators will conduct a cluster randomized trial comparing the intervention to enhanced usual care (eUC) in 20 Bronx practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC practices will receive guideline information and assess children's asthma severity and control, but active intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 practices per year). Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with persistent or uncontrolled asthma from intervention and eUC practices will be evaluated using Electronic Health Records (EHR) data and practice-based screening for asthma severity and control. Investigators will also enroll a random subset of 512 caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate caregiver-reported child morbidity outcomes and obtain measures not available in EHR.
Intervention consists of academic detailing in the EHR that follow national asthma guidelines and outreach worker care coordination for patients with persistent or uncontrolled asthma.
Comment: While caregivers reported on child outcomes, caregivers were not subjects of the study. See "Pre-Assignment Details" section within the Participant Flow module for more details.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Follow up assessments will be collected by blinded interviewers
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The criteria listed below will apply to ~5,000 children from eMPI and eUC practices:
- •Physician-diagnosed asthma (based on EHR)
- •Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines, any one of the following: in past month, > 2 days/week with asthma symptoms, >2 days/week with rescue medication use, >2 days/month with nighttime symptoms, or > 2 episodes in the past year that required systemic corticosteroids
- •Age 2 and 12 years, inclusive
- •Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to obtain caregiver-reported morbidity outcomes:
- •Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be eligible as all surveys will be administered verbally by research personnel
- •Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from the child (>7 years). If there are eligible siblings, only one child will be randomly selected
排除标准
- •The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures
- •Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
- •No access to a telephone to conduct follow-up surveys
- •Children in foster care or other situations in which consent cannot be obtained from a guardian
结局指标
主要结局
Percentage of Participants With 1 or More Guideline-based Corrective Actions Taken
时间窗: Immediately post-intervention, up to 1 year
The percentage of participants with 1 or more guideline-based corrective actions taken (i.e., controller medication prescription or adjustment, trigger evaluation), as recorded in the electronic health record (EHR) is reported. Results are summarized in number/percentage of participants with 1 or more guideline-based corrective actions taken by study arm.
次要结局
- Symptom Free Days (SFDs)(Baseline, and 3 month, 6 month, 9 month, and 12 month follow-up evaluations)