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

Lifespan

Status: Terminated

Conditions: Asthma

Treatments: Other: Standard Asthma Discharge Instructions; Drug: fluticasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01881412

ACP-231928-N (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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118 participants in 2 patient groups, including a placebo group

Inhaled corticosteroid (fluticasone)

Experimental group

Description:

Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.

Treatment:

Drug: fluticasone

Other: Standard Asthma Discharge Instructions

Routine Asthma Care

Placebo Comparator group

Description:

Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)

Treatment:

Other: Standard Asthma Discharge Instructions