Asthma
Conditions
Keywords
Asthma, Children, Inhaled Corticosteroids, Emergency Department
Brief summary
Many children have asthma and this causes problems with their health. A lot of children with uncontrolled asthma use emergency departments for asthma care, and so this is an ideal place for an intervention for these children. One intervention is prescribing inhaled steroids to children with uncontrolled asthma, but currently this is rarely done in the emergency department. Inhaled steroids have been shown to be good at making children better long-term when they have uncontrolled asthma. This study identifies children in the emergency department with uncontrolled asthma using a tool called the Pediatric Asthma Control and Communication Instrument (PACCI). If children meet criteria for uncontrolled asthma they will be randomly assigned to either: 1) routine asthma care which includes close follow up with their doctor or 2) prescribing of an inhaled corticosteroid from the emergency department. The investigators hypothesize that children who are prescribed inhaled steroids for uncontrolled asthma from the emergency department will have better 6 month asthma control than children who receive routine asthma care.
Detailed description
Specific aim 1 - An ED-based RCT to determine if ICS prescription in children identified using the PACCI as having uncontrolled asthma results in less asthma morbidity compared to routine asthma care. We hypothesize that children receiving ICS prescriptions will have fewer unscheduled health care use for asthma exacerbations (doctor's office visits, ED visits, or hospitalizations), and greater quality of life. Specific aim 2 - Thematic analysis of interviews with parents who are adherent versus non-adherent with ICS prescription filling and use to determine the factors associated with adherence. We hypothesize that factors will include: 1) Parent beliefs about the chronic versus episodic nature of asthma, 2) Parent's knowledge of benefits and risks of ICS, and 3) Provision and use of an asthma action plan.
Interventions
DRUGfluticasone
During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.
OTHERStandard Asthma Discharge Instructions
Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
Sponsors
American Lung Association
Rhode Island Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 3 - 12 years of age * child has asthma diagnosed by a doctor based on parental/caregiver report * child is not already properly using an ICS or being discharged with an ICS
Exclusion criteria
* The child has previously participated in this study * The child has major co-morbid disease of the heart or lungs (examples include cystic fibrosis, heart disease, muscular dystrophy and cerebral palsy with immobility. It does not include allergic rhinitis or a history of respiratory infections such as pneumonia or bronchiolitis. * The child's parents/caregivers do not speak English * The child is not going to be discharged from the emergency department (e.g. hospitalization)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form | 6 months | The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ED Visits for Asthma | 6 months | Emergency department visits for asthma over a 6 month period by parent report. |
| Primary Care Visits for Well Checks | 6 months | Primary care visits well checks over a 6 month period by parent report. |
| Hospitalizations for Asthma | 6 months | Hospitalizations for asthma over a 6 month period by parent report. |
| Unscheduled Primary Care Visits | 6 months | Unscheduled primary care visits for asthma over a 6 month period by parent report. |
| Oral Steroid Courses | 6 months | Oral steroid courses over a 6 month period by parent report. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Inhaled Corticosteroid (ICS) Child receives: 1) asthma discharge instructions, and 2) ICS prescription.
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.
The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use. | 59 |
| Routine Asthma Care Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated. | 59 |
| Total | 118 |
Baseline characteristics
| Characteristic | Inhaled Corticosteroid (ICS) | Routine Asthma Care | Total |
|---|---|---|---|
| Age, Continuous | 6.1 years STANDARD_DEVIATION 2.4 | 6.4 years STANDARD_DEVIATION 2.3 | 6.3 years STANDARD_DEVIATION 2.4 |
| Race/Ethnicity, Customized Black | 7 Participants | 13 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 20 Participants | 19 Participants | 39 Participants |
| Race/Ethnicity, Customized Mixed race / other | 8 Participants | 13 Participants | 21 Participants |
| Race/Ethnicity, Customized White | 24 Participants | 14 Participants | 38 Participants |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 38 Participants |
| Sex: Female, Male Male | 43 Participants | 37 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 59 |
| other Total, other adverse events | 0 / 59 | 0 / 59 |
| serious Total, serious adverse events | 0 / 59 | 0 / 59 |
Outcome results
Primary
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form | 90 score on a scale | Standard Deviation 14 |
| Routine Asthma Care | Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form | 84 score on a scale | Standard Deviation 16 |
Secondary
ED Visits for Asthma
Emergency department visits for asthma over a 6 month period by parent report.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | ED Visits for Asthma | .37 visits | Standard Deviation 1 |
| Routine Asthma Care | ED Visits for Asthma | 0.56 visits | Standard Deviation 0.8 |
Secondary
Hospitalizations for Asthma
Hospitalizations for asthma over a 6 month period by parent report.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | Hospitalizations for Asthma | .06 Hospitalizations | Standard Deviation 0.32 |
| Routine Asthma Care | Hospitalizations for Asthma | .05 Hospitalizations | Standard Deviation 0.23 |
Secondary
Oral Steroid Courses
Oral steroid courses over a 6 month period by parent report.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | Oral Steroid Courses | .54 Courses | Standard Deviation 0.87 |
| Routine Asthma Care | Oral Steroid Courses | 0.7 Courses | Standard Deviation 1.1 |
Secondary
Primary Care Visits for Well Checks
Primary care visits well checks over a 6 month period by parent report.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | Primary Care Visits for Well Checks | 1 visits | Standard Deviation 1.1 |
| Routine Asthma Care | Primary Care Visits for Well Checks | 0.6 visits | Standard Deviation 0.8 |
Secondary
Unscheduled Primary Care Visits
Unscheduled primary care visits for asthma over a 6 month period by parent report.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inhaled Corticosteroid (Fluticasone) | Unscheduled Primary Care Visits | .8 visits | Standard Deviation 1 |
| Routine Asthma Care | Unscheduled Primary Care Visits | 1.7 visits | Standard Deviation 2.8 |