Asthma
Conditions
Keywords
Pediatric, Emergency department visit
Brief summary
Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma check-up , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.
Detailed description
Asthma, the leading chronic disorder in childhood, is the number one cause of pediatric emergency department (ED) visits in young children and is responsible for a substantial impact on healthcare costs. The ED is often the point of contact for low-income children and many families view the ED as their primary source of asthma care. Poor and minority children have the highest asthma morbidity, are the least likely to receive adequate preventive therapy or specialty care and more frequently exposed to environmental triggers than non-poor children. However, prior studies, including our pilot, indicate that children with frequent asthma ED visits will attend a one-time ED-based follow-up clinic for an asthma check-up and education. The goal of this randomized controlled trial is to test the efficacy of a multifaceted, ED + primary care provider (PCP) and home-based intervention, Asthma Express (AEx), for children with \> 2 asthma ED visits or 1 hospitalization/year that provides tailored guideline based asthma care. Allergy and cotinine biomarkers, collected during the ED visit, are used to target the home environmental control component of the intervention. The AEx intervention (n=132) will be compared to an attention control (CON) group (n=132) for the specific aims: (1) to reduce asthma morbidity (increase symptom free days and nights) and decrease ED visits and hospitalizations and increase asthma control and caregiver quality of life, (2) to improve the use of appropriate preventive anti-inflammatory medication based on child pharmacy refill records and (3) to compare the economic cost and effects of this intervention. Children aged 3-12 years with \> 2 asthma ED visits or 1 hospitalization within the past 12 months and a current ED visit for asthma will be recruited from the Johns Hopkins Pediatric-ED and followed for 12 months. Symptom frequency, health care utilization, caregiver quality of life and cotinine measures will be collected at baseline, 6 and 12 months and pharmacy data collected at baseline and 12 months. Data analysis includes initial cross tabulations of health outcomes by group (AEx vs. CON) and multivariate generalized linear regression models to study the effects of the AEx treatment on mean symptom free days/nights, repeat ED visits, hospitalizations and caregiver quality of life scores and anti-inflammatory medication refills. Mean total costs of ED, PCP visits, hospital days and medication costs will be compared between groups (AEx and CON) for the economic analysis. The AEx model is designed to be accessible, guideline-based, easily replicated and incorporated into ED care. If successful, this study will fill critical gaps in the ED transition to preventive care asthma interventional research.
Interventions
Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express home nurse visits for asthma education
Sponsors
Study design
Eligibility
Inclusion criteria
* asthma diagnosis, * age 3 to 12 years, * two or more ED visits or one hospitalization for asthma within past 12 months, -working phone
Exclusion criteria
-other respiratory chronic disease such as Cystic Fibrosis or Bronchopulmonary dysplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Days | 3 months | Symptom days for asthma during past 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department (ED) Visits for Asthma | 3 months | Number of emergency department visits for asthma in the past 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asthma Express Intervention Clinic visit for asthma education + nurse home visits
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education | 107 |
| Standard ASthma Education Control Group STandard asthma education delivered in home by nurse
Asthma Express Intervention: Asthma Express clinic visit for asthma education + nurse home visit
Asthma Express Control Arm: Asthma Express home nurse visits for asthma education | 115 |
| Total | 222 |
Baseline characteristics
| Characteristic | Asthma Express Intervention | Standard ASthma Education Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 107 Participants | 115 Participants | 222 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.2 years STANDARD_DEVIATION 2.7 | 6.5 years STANDARD_DEVIATION 2.6 | 6.3 years STANDARD_DEVIATION 2.7 |
| Emergency Department visits over past 3 months | 1.02 Number of ED visits over past 3 months STANDARD_DEVIATION 1.1 | 1.48 Number of ED visits over past 3 months STANDARD_DEVIATION 1.6 | 1.26 Number of ED visits over past 3 months STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 112 Participants | 215 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 101 Participants | 107 Participants | 208 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 107 participants | 115 participants | 222 participants |
| Sex: Female, Male Female | 45 Participants | 35 Participants | 80 Participants |
| Sex: Female, Male Male | 62 Participants | 80 Participants | 142 Participants |
| Symptoms days past 14 days | 5.55 symptom days STANDARD_DEVIATION 4.6 | 6.17 symptom days STANDARD_DEVIATION 4.9 | 5.88 symptom days STANDARD_DEVIATION 4.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 106 |
| other Total, other adverse events | 0 / 98 | 0 / 106 |
| serious Total, serious adverse events | 0 / 98 | 0 / 106 |
Outcome results
Symptom Days
Symptom days for asthma during past 14 days
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Express Intervention | Symptom Days | 6.24 symptom days over past 14 days | Standard Deviation 5.7 |
| Standard ASthma Education Control Group | Symptom Days | 4.82 symptom days over past 14 days | Standard Deviation 5.1 |
Emergency Department (ED) Visits for Asthma
Number of emergency department visits for asthma in the past 3 months
Time frame: 3 months
Population: No data for one participant in the control group for this outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Asthma Express Intervention | Emergency Department (ED) Visits for Asthma | 0.64 visits | Standard Deviation 2.26 |
| Standard ASthma Education Control Group | Emergency Department (ED) Visits for Asthma | 0.62 visits | Standard Deviation 1.02 |