Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
Condition: Asthma
MeSH terms: Asthma; Emergencies
Study type: Interventional

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.
    

Intervention name(s): ICS Prescription + Standard Asthma ED Discharge Therapy; Standard Asthma ED Discharge Therapy
Intervention type(s): Other; Other
Intervention description(s): 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; 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.
Other intervention name(s): Budesonide; Fluticasone propionate; Pulmicort; Flovent; Control
Intervention MeSH terms: Fluticasone; Xhance; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asthma, Controller Medications