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

Optimizing Discharge After Emergency Department Visits for Children With Uncontrolled Asthma

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.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: fluticasone; Other: Standard Asthma Discharge Instructions

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Rhode Island Hospital / Hasbro Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inhaled corticosteroid (fluticasone); Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.	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 Names: inhaled corticosteroid; 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)
Placebo Comparator: Routine Asthma Care; Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ED Visits for Asthma	Emergency department visits for asthma over a 6 month period by parent report.	6 months
Primary Care Visits for Well Checks	Primary care visits well checks over a 6 month period by parent report.	6 months
Hospitalizations for Asthma	Hospitalizations for asthma over a 6 month period by parent report.	6 months
Unscheduled Primary Care Visits	Unscheduled primary care visits for asthma over a 6 month period by parent report.	6 months
Oral Steroid Courses	Oral steroid courses over a 6 month period by parent report.	6 months

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: American Lung Association
• Investigators: Principal Investigator: Aris C Garro, MD, MPH, Brown University and Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: June 17, 2013
• First Submitted That Met QC Criteria: June 18, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Children; Emergency Department; Inhaled Corticosteroids
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Emergencies; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone
• Other Study ID Numbers: ACP-231928-N (Other Grant/Funding Number: American Lung Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Availability on request
• IPD Sharing Time Frame: Data currently available on request
• IPD Sharing Access Criteria: Requests will be reviewed by the study investigators for appropriateness
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF