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Asthma Express: Bridging the Emergency to Primary Care in Underserved Children

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ClinicalTrials.gov Identifier: NCT01981564
Recruitment Status : Completed
First Posted : November 11, 2013
Results First Posted : April 13, 2018
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Asthma is the number one cause of pediatric emergency department (ED) visits in young minority children and is responsible for high healthcare costs. The ED is often the point of contact for many inner city children and many families view the ED as the child's primary source of asthma care. This study plans to test a new model of asthma care, Asthma Express (AEx), that includes a follow-up asthma visit in the ED for an asthma "check-up" , asthma education, a prescription for preventive asthma medications, an appointment for the child to see their pediatric provider and a home visit to assist families with environmental control methods to prevent asthma symptoms.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Asthma Express Intervention Behavioral: Standard Asthma Education Control Group Not Applicable

Detailed Description:
Asthma, the leading chronic disorder in childhood, is the number one cause of pediatric emergency department (ED) visits in young children and is responsible for a substantial impact on healthcare costs. The ED is often the point of contact for low-income children and many families view the ED as their primary source of asthma care. Poor and minority children have the highest asthma morbidity, are the least likely to receive adequate preventive therapy or specialty care and more frequently exposed to environmental triggers than non-poor children. However, prior studies, including our pilot, indicate that children with frequent asthma ED visits will attend a one-time ED-based follow-up clinic for an asthma "check-up" and education. The goal of this randomized controlled trial is to test the efficacy of a multifaceted, ED + primary care provider (PCP) and home-based intervention, Asthma Express (AEx), for children with > 2 asthma ED visits or 1 hospitalization/year that provides tailored guideline based asthma care. Allergy and cotinine biomarkers, collected during the ED visit, are used to target the home environmental control component of the intervention. The AEx intervention (n=132) will be compared to an attention control (CON) group (n=132) for the specific aims: (1) to reduce asthma morbidity (increase symptom free days and nights) and decrease ED visits and hospitalizations and increase asthma control and caregiver quality of life, (2) to improve the use of appropriate preventive anti-inflammatory medication based on child pharmacy refill records and (3) to compare the economic cost and effects of this intervention. Children aged 3-12 years with > 2 asthma ED visits or 1 hospitalization within the past 12 months and a current ED visit for asthma will be recruited from the Johns Hopkins Pediatric-ED and followed for 12 months. Symptom frequency, health care utilization, caregiver quality of life and cotinine measures will be collected at baseline, 6 and 12 months and pharmacy data collected at baseline and 12 months. Data analysis includes initial cross tabulations of health outcomes by group (AEx vs. CON) and multivariate generalized linear regression models to study the effects of the AEx treatment on mean symptom free days/nights, repeat ED visits, hospitalizations and caregiver quality of life scores and anti-inflammatory medication refills. Mean total costs of ED, PCP visits, hospital days and medication costs will be compared between groups (AEx and CON) for the economic analysis. The AEx model is designed to be accessible, guideline-based, easily replicated and incorporated into ED care. If successful, this study will fill critical gaps in the ED transition to preventive care asthma interventional research.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Asthma Express Intervention to Bridge Emergency to Primary Care for High Risk Children With Asthma
Actual Study Start Date : April 15, 2013
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Asthma Express Intervention
Clinic visit for asthma education + nurse home visits
Behavioral: Asthma Express Intervention
Asthma Express clinic visit for asthma education + nurse home visit
Other Name: Asthma Express

Active Comparator: Standard Asthma Education Control group
Standard asthma education during nurse home visits
Behavioral: Standard Asthma Education Control Group
Asthma Express home nurse visits for asthma education
Other Name: Attention Control




Primary Outcome Measures :
  1. Symptom Days [ Time Frame: 3 months ]
    Symptom days for asthma during past 14 days


Secondary Outcome Measures :
  1. Emergency Department (ED) Visits for Asthma [ Time Frame: 3 months ]
    Number of emergency department visits for asthma in the past 3 months



Information from the National Library of Medicine

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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:

  • asthma diagnosis,
  • age 3 to 12 years,
  • two or more ED visits or one hospitalization for asthma within past 12 months, -working phone

Exclusion Criteria:

-other respiratory chronic disease such as Cystic Fibrosis or Bronchopulmonary dysplasia


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): NCT01981564


Locations
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United States, Maryland
Johns Hopkins Hospital Pediatric Emergency Department
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Arlene M Butz, ScD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01981564     History of Changes
Obsolete Identifiers: NCT01970085
Other Study ID Numbers: NA00078937
R01NR013486 ( U.S. NIH Grant/Contract )
First Posted: November 11, 2013    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: March 6, 2019
Last Verified: March 2019

Keywords provided by Johns Hopkins University:
Pediatric
Emergency department visit

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