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

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ClinicalTrials.gov Identifier: NCT01881412
Recruitment Status : Terminated (Funding complete)
First Posted : June 19, 2013
Last Update Posted : April 11, 2018
Sponsor:
Collaborator:
American Lung Association
Information provided by (Responsible Party):
Rhode Island Hospital

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: fluticasone Other: Standard Asthma Discharge Instructions Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Actual Study Start Date : August 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

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 Name: 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)




Primary Outcome Measures :
  1. Quality-of-life (using ITG-CASF) [ Time Frame: 6 months ]
    The 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 - 100, 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 :
  1. Unscheduled Health Care Use [ Time Frame: 6 months ]
    These measures will include unscheduled visits to primary care providers (PCPs) for asthma, emergency department visits for asthma, and hospitalizations. We will use parent reports for the 6 month period. Hospital and PCP medical records will be used to corroborate reported data, and for families that are unable to be contacted.

  2. Medication fills [ Time Frame: 6 months ]
    Preferred pharmacies as indicated by participants will be contacted to quantify the number of asthma-related medication refills during the time period.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881412


Locations
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United States, Rhode Island
Rhode Island Hospital / Hasbro Children's Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Rhode Island Hospital
American Lung Association
Investigators
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Principal Investigator: Aris C Garro, MD, MPH Brown University and Rhode Island Hospital

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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT01881412     History of Changes
Other Study ID Numbers: ACP-231928-N
ACP-231928-N ( Other Grant/Funding Number: American Lung Association )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rhode Island Hospital:
Asthma
Children
Inhaled Corticosteroids
Emergency Department
Additional relevant MeSH terms:
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Asthma
Emergencies
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents