Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO Plan)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 12
- 主要终点
- PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
研究概览
简要总结
Chicago is an epicenter for asthma health disparities in the U.S., with African-American children 5-11 yrs bearing a disproportionate share of the burden. Among the most visible of these disparities is the high rate of visits to the Emergency Department (ED) for uncontrolled asthma. Clinical uncertainties regarding the real-world effectiveness of guideline recommendations for ED discharge and strategies to reduce environmental triggers at home contribute to practice variation and poor adherence to guidelines. The CHICAGO Plan tests both ED- and home-level interventions to improve clinically meaningful outcomes in a minority pediatric ED population with uncontrolled asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
PROMIS Satisfaction With Participation in Social Roles (v1.0, SF4a)
时间窗: Baseline and 6 months after index ED discharge
Raw scores (4-20) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate less satisfaction among caregivers; high scores indicate more satisfaction among caregivers. PROMIS Satisfaction With Participation in Social Roles: Min possible T-score: 29.0; Max possible T-score: 64.1 Possible range for change in T-score is \[-35.1 to 35.1\] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates less satisfaction among caregivers. A positive change in score indicates a more satisfaction among caregivers. A score of 0 indicates no change.
PROMIS Asthma Impact Scale (v1.0, SF8a)
时间窗: Baseline and 6 months after index ED discharge
Raw scores (0-32) were converted to T-scores to measure change from index visit to 6-month primary endpoint. Low scores indicate better asthma; high scores indicate worse asthma. PROMIS Asthma Impact Scale, Pediatric: Min possible T-score: 31.5; Max possible T-score: 76.2 Possible range for change in T-score is \[-44.7 to 44.7\] PROMIS Asthma Impact Scale, Parent proxy: Min possible T-score: 32; Max possible T-score: 80 Possible range for change in T-score is \[-48 to 48\] The reported value represents a change in T-score from baseline to 6 months after index ED discharge. A negative change in score indicates improvement in asthma. A positive change in score indicates worsening of asthma. A score of 0 indicates no change.
次要结局
- Childhood Asthma Control Test (cACT)(Baseline and 6 months after index ED discharge)
- PROMIS Sleep Disturbance (v1.0, SF4a)(Baseline and 6 months after index ED discharge)
- Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)(Baseline and 6 months after index ED discharge)
- PROMIS Anxiety (v1.0, SF4a)(Baseline and 6 months after index ED discharge)
- PROMIS Fatigue (v1.0, SF4a)(Baseline and 6 months after index ED discharge)
- PROMIS Depression (v1.0, SF4a)(Baseline and 6 months after index ED discharge)
- Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Systemic Corticosteroids(At index ED discharge)
- Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Inhaled Corticosteroids or Other Controller(7 days post index ED discharge)
- Number of Participants With All-cause Emergency Department (ED) or Urgent Care Visits(6 months post index ED discharge)
- Number of Participants With All-cause Hospitalizations(6 months post index ED discharge)
- Self-management Practices After ED Discharge: Number of Participants Who Filled Prescriptions for Systemic Corticosteroids(7 days post index ED discharge)
- Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Rescue Medication(At index ED discharge)
- Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received a Follow-up Appointment Scheduled by ED Staff(At index ED discharge)
- Self-management Practices After ED Discharge: Number of Participants Who Attended an Outpatient Appointment With Patient-identified Asthma Provider(4 weeks post index ED discharge)
- Indicator of Guideline-consistent Care Provided on ED Discharge: Number of Participants Who Received Instructions to Use Inhaled Corticosteroids or Other Controller(At index ED discharge)
研究者
Jerry Krishnan
Associate Vice Chancellor for Population Health Sciences, Professor of Medicine and Public Health
University of Illinois at Chicago