Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
NCT01881412 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2020-05-18
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.
Conditions
Interventions
- DRUG
-
fluticasone
During 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 Instructions
Study 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)
Sponsors & Collaborators
-
American Lung Association
collaborator OTHER -
Rhode Island Hospital
lead OTHER
Principal Investigators
-
Aris C Garro, MD, MPH · Brown University and Rhode Island Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2017-12-31
- Completion
- 2018-04-30
Countries
- United States
Study Locations
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