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Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma

Not Applicable
Terminated
Conditions
Asthma
Interventions
Other: Standard Asthma Discharge Instructions
Registration Number
NCT01881412
Lead Sponsor
Rhode Island Hospital
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
118
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Inhaled corticosteroid (fluticasone)fluticasoneChild receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
Inhaled corticosteroid (fluticasone)Standard Asthma Discharge InstructionsChild receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
Routine Asthma CareStandard Asthma Discharge InstructionsChild receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Primary Outcome Measures
NameTimeMethod
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form6 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 Outcome Measures
NameTimeMethod
Primary Care Visits for Well Checks6 months

Primary care visits well checks over a 6 month period by parent report.

ED Visits for Asthma6 months

Emergency department visits for asthma over a 6 month period by parent report.

Hospitalizations for Asthma6 months

Hospitalizations for asthma over a 6 month period by parent report.

Unscheduled Primary Care Visits6 months

Unscheduled primary care visits for asthma over a 6 month period by parent report.

Oral Steroid Courses6 months

Oral steroid courses over a 6 month period by parent report.

Trial Locations

Locations (1)

Rhode Island Hospital / Hasbro Children's Hospital

🇺🇸

Providence, Rhode Island, United States

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