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

Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:fluticasoneDuring discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.

Other:Standard Asthma Discharge InstructionsStudy MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Terminated

Start Date: August 2012

Completed Date: April 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Quality-of-life (using ITG-CASF)

Secondary Outcome: Unscheduled Health Care Use

Study sponsors, principal investigator, and references

Principal Investigator: Aris C Garro, MD, MPH

Lead Sponsor: Rhode Island Hospital

Collaborator: American Lung Association

More information:https://clinicaltrials.gov/show/NCT01881412

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