Clinical trial NCT01881412: Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Official title: Optimizing Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Children
Inhaled Corticosteroids
Emergency Department
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2013-06-19
Enrollment: 118
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
timeFrame: 6 months
Secondary outcomes:
measure: ED Visits for Asthma
timeFrame: 6 months
measure: Primary Care Visits for Well Checks
timeFrame: 6 months
measure: Hospitalizations for Asthma
timeFrame: 6 months
measure: Unscheduled Primary Care Visits
timeFrame: 6 months
measure: Oral Steroid Courses
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital / Hasbro Children's Hospital
state: Rhode Island
Study officials:
affiliation: Brown University and Rhode Island Hospital
name: Aris C Garro, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: