Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination in Clinics and Schools (PRAGMATIC-S)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Asthma Control - continuous
研究概览
简要总结
The overall goal of this research study is to evaluate a multi-level program called PRAGMATIC-S to improve the delivery of guideline-based asthma care through a unique partnership between clinical practices and schools. PRAGMATIC-S represents a novel approach that addresses multiple barriers to adherence by bridging primary care and schools, ensuring delivery of guideline-based asthma care to urban children across these settings thereby improving adherence to therapy and clinical outcomes.
详细描述
The research team will conduct a cluster randomized controlled trial, enrolling 420 children, ages 4-12, from 18 Montefiore clinics during office visits. Children in the intervention group (PRAGMATIC-S) will receive updated guideline-based care prompts, with providers completing the medication administration form (MAF), electronically signing it, and routing it directly to the school via the EHR system. Asthma Outreach Worker (AOW) care coordination will support daily adherence to prescribed treatments at home and school. Children in the control group will receive enhanced usual care, which includes EHR prompts for guideline-based care but without the additional PRAGMATIC-S components.
Participants will be followed for 12 months. Outcomes will be assessed as outlined in this registration.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma documented in EHR
- •Persistent or uncontrolled asthma, defined by age-specific guidelines (symptoms ≥2 days/week, rescue medication use ≥2 days/week, nighttime symptoms ≥2 days/month, or ≥2 steroid-requiring episodes/year)
- •Age 4 to 12 years, attending pre-kindergarten through 6th grade in NYC public schools
- •Caregiver able to speak English or Spanish
- •Consent from primary caregiver and assent from child (if ≥7 years)
- •Presence of phone and device (smartphone, iPad, or computer) to complete electronic forms
排除标准
- •Family plans to leave school/city within 6 months
- •Significant comorbidities (e.g., congenital heart disease, cystic fibrosis, chronic lung disease)
- •Children in foster care or situations where legal guardian consent cannot be obtained
- •Participation in concurrent asthma intervention study
- •Severe developmental delay precluding completion of ACT questionnaire
研究组 & 干预措施
PRAGMATIC-S
Primary Care Providers (PCPs) will use guideline-based prompts within EHR; PCPs and caregivers will complete medication administration forms electronically with forms routed directly to schools to receive asthma medications at the school, and asthma outreach workers will serve as liaison between families, PCPs, schools and provide care coordination and support.
干预措施: PRAGMATIC-S (Behavioral)
Enhanced Usual Care
Standard of care EHR clinician prompts for guideline-based asthma care
结局指标
主要结局
Asthma Control - continuous
时间窗: Baseline, 4 months, 8 months, and 12 months
Asthma control will be measured using the Childhood Asthma Control Test (cACT), 7-item scale which determines a score based on the sum of the response codes. The child answers the first 4 questions on a 4-point scale ranging from 0-3 and the caregiver provides responses for the final 3 items using a reverse-coded scale ranging from 0-5, yielding an overall possible scoring range of 0-27, with higher scores indicating better asthma control. Asthma control will be analyzed as a continuous variable.
次要结局
- Pediatric Asthma Caregiver's Quality of Life(Baseline, 4 months, 8 months, and 12 months)
- Percent of participants with 1 or more guideline-based corrective actions taken(Up to 24 months (following intervention))
- Asthma Control - dichotomous(Baseline, 4 months, 8 months, and 12 months)