search
Back to results

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

Primary Purpose

Asthma

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluticasone
Standard Asthma Discharge Instructions
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Children, Inhaled Corticosteroids, Emergency Department

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept 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)

Sites / Locations

  • Rhode Island Hospital / Hasbro Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inhaled corticosteroid (fluticasone)

Routine Asthma Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2013
Last Updated
May 15, 2020
Sponsor
Rhode Island Hospital
Collaborators
American Lung Association
search

1. Study Identification

Unique Protocol Identification Number
NCT01881412
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Funding complete
Study Start Date
August 2012 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rhode Island Hospital
Collaborators
American Lung Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Children, Inhaled Corticosteroids, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inhaled corticosteroid (fluticasone)
Arm Type
Experimental
Arm Description
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
Arm Title
Routine Asthma Care
Arm Type
Placebo Comparator
Arm Description
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Intervention Type
Drug
Intervention Name(s)
fluticasone
Other Intervention Name(s)
inhaled corticosteroid
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Asthma Discharge Instructions
Intervention Description
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)
Primary Outcome Measure Information:
Title
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ED Visits for Asthma
Description
Emergency department visits for asthma over a 6 month period by parent report.
Time Frame
6 months
Title
Primary Care Visits for Well Checks
Description
Primary care visits well checks over a 6 month period by parent report.
Time Frame
6 months
Title
Hospitalizations for Asthma
Description
Hospitalizations for asthma over a 6 month period by parent report.
Time Frame
6 months
Title
Unscheduled Primary Care Visits
Description
Unscheduled primary care visits for asthma over a 6 month period by parent report.
Time Frame
6 months
Title
Oral Steroid Courses
Description
Oral steroid courses over a 6 month period by parent report.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aris C Garro, MD, MPH
Organizational Affiliation
Brown University and Rhode Island Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rhode Island Hospital / Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

We'll reach out to this number within 24 hrs