Asthma
Conditions
Keywords
Asthma, Controller Medications
Brief summary
Specific Aim: To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (ED) discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit. Hypotheses: In a cohort of pediatric patients with persistent asthma discharged from the ED after an acute asthma exacerbation, a prescription for ICS will: 1. Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit 2. Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work 3. Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma Health Related Quality of Life (HRQL) 4. Improve asthma control at 2 months as measured by a validated asthma instrument
Detailed description
Abstract. Background: Asthma prevalence, emergency visits, and hospitalizations have increased substantially, especially among young children and urban populations. Although inhaled corticosteroids (ICS) are the mainstay of treatment for persistent asthma, studies have demonstrated a low rate of ICS usage and primary care provider follow-up within a month of an Emergency Department (ED) visit. Furthermore, ICS usage and adherence with National Asthma Education and Prevention Program (NAEPP) recommendations is low even for children that follow-up with their primary care physician (PCP). In addition, other studies have demonstrated frequent symptoms, activity restriction, and missed school or work during the weeks following an ED visit. Prescribing ICS at ED discharge occurs uncommonly in the United States based on surveys and reviews of current practice. Adult studies have been inconclusive and the role of ICS after a pediatric emergency visit for asthma has not been studied. This study will assess the short-term outcomes of prescribing ICS to young children with persistent asthma symptoms after an emergency visit for asthma. Objective: To determine whether a prescription for ICS added to standard asthma ED discharge therapy to young children with persistent asthma increases adherence to NAEPP guidelines for ICS usage at 2 months follow up and improves short-term symptoms and quality of life for patient and caregiver. Methods: Randomized control trial of children 1- 8yo of age with persistent asthma being discharged after an emergency visit for asthma. Subjects will be randomized to receive standard therapy of oral corticosteroid, albuterol, and education versus standard care plus a prescription for budesonide once daily. A questionnaire will be administered at baseline, with follow-up telephone interviews conducted at 2 weeks and 2 months. Pharmacy verification of refill of a second prescription of ICS will be the primary outcome. Asthma symptoms and quality of life will be assessed as secondary outcomes.
Interventions
OTHERICS Prescription + Standard Asthma ED Discharge Therapy
Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
OTHERStandard Asthma ED Discharge Therapy
Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age 12 months through 18 years 2. History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed 3. Persistent symptoms identified by an asthma control tool based on the NAEPP Guidelines and developed and validated by a multidisciplinary team of clinicians from CHOP Allergy, Pulmonary Medicine, General Pediatrics and Emergency Medicine. 4. Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone 5. Have a Primary Care Physician (PCP)
Exclusion criteria
1. Current hospitalization or admission to the extended day emergency care unit 2. History of pediatric intensive care admission for asthma 3. Current prescription for a controller medication such as inhaled corticosteroids (ICS), leukotriene receptor antagonists, or cromolyn 4. Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids 5. Co-morbid disease: Chronic lung disease, for example cystic fibrosis; Congenital heart disease requiring surgery and/or medications; Sickle cell disease; Immunodeficiency syndromes 6. Previous enrollment in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) | 2 months | Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma-related Quality of Life | 2 months | Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life. |
Countries
United States
Participant flow
Recruitment details
Patients were screened for enrollment at the Children's Hospital of Philadelphia Emergency Department (ED) between 2006 to 2009. Of the 75,000 annual ED visits in the Children's Hospital of Philadelphia ED per year, more than 6,000 of these visit represent patients with acute asthma.
Pre-assignment details
152 participants were enrolled and randomized between 2006 and 2009 in the Children's Hospital of Philadelphia Emergency Department.
Participants by arm
| Arm | Count |
|---|---|
| Standard Asthma ED Discharge Therapy Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed. | 78 |
| ICS Prescription + Standard ED Discharge Therapy Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily | 74 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 26 |
Baseline characteristics
| Characteristic | ICS Prescription + Standard ED Discharge Therapy | Standard Asthma ED Discharge Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 78 Participants | 152 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 | 5.5 years STANDARD_DEVIATION 4.8 | 4.5 years STANDARD_DEVIATION 3.1 | 5.0 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 74 participants | 78 participants | 152 participants |
| Sex: Female, Male Female | 36 Participants | 30 Participants | 66 Participants |
| Sex: Female, Male Male | 38 Participants | 48 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 78 | 0 / 74 |
| serious Total, serious adverse events | 0 / 78 | 0 / 74 |
Outcome results
Primary
Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)
Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.
Time frame: 2 months
Population: Analysis population was based on the intention to treat number at enrollment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Asthma ED Discharge Therapy | Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) | 18 Participants |
| ICS Prescription + Standard Asthma ED Discharge Therapy: | Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) | 32 Participants |
p-value: 0.87t-test, 2 sided
Secondary
Asthma-related Quality of Life
Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.
Time frame: 2 months
Population: Analysis population was based on the intention to treat number at enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Asthma ED Discharge Therapy | Asthma-related Quality of Life | 65 units on a scale | Standard Deviation 21 |
| ICS Prescription + Standard Asthma ED Discharge Therapy: | Asthma-related Quality of Life | 66 units on a scale | Standard Deviation 27 |