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Sponsors and Collaborators: |
Johns Hopkins University University of Maryland University of Rochester |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00860418 |
Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough.
The investigators hypothesize that:
Condition | Intervention | Phase |
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Asthma |
Behavioral: Pediatric Asthma Alert (PAAL) Behavioral: Standard asthma education |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Pediatric Asthma Alert Intervention for Minority Children |
Estimated Enrollment: | 350 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | June 2013 |
Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Standard asthma education delivered during 2 home visits by a nurse.
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Behavioral: Standard asthma education
Standard asthma education during 2 home visits.
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2 PAAL: Experimental
PAAL
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Behavioral: Pediatric Asthma Alert (PAAL)
Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
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Asthma is the number one cause of pediatric emergency department (ED) visits in young children and results in a significant economic impact on society and use of health resources. Reliance on the ED for asthma care is not only costly but it is also a dangerous index of poorly controlled asthma. Recent updated national asthma guidelines recommend daily inhaled corticosteroids (ICS) as the cornerstone of treatment for patients with persistent asthma.
When properly used ICS prevent exacerbations, ED visits and hospitalizations and maintain asthma control. However, > 50% of inner city minority children with asthma do not receive or use recommended anti-inflammatory preventive medications. In fact, many children encounter repeated ED visits with no provision of appropriate preventive medications or other components of guideline-based preventive care because of inconsistent follow-up with their primary care provider (PCP). The overall goal of this study is to evaluate whether a standardized caregiver and physician prompting intervention, Pediatric Asthma Alert Leader (PAAL), can improve guideline-based preventive asthma care including increased anti-inflammatory use and preventive PCP visits in children with frequent ED visits. This study builds on the experience with our parent-child-PCP communication intervention ("Improving Asthma Communication in Minority Families", ACE) in which we found that teaching parent and child asthma communication skills resulted in increased anti-inflammatory medication use at 6 months for children with persistent asthma. However, the beneficial effects of this intervention were seen primarily when caregivers and children were reminded by the nurse interventionist to relay specific health information to the PCP. Furthermore, the intervention was not associated with decreased ED visits or appropriate PCP follow-up to sustain preventive care. The proposed PAAL intervention has the potential to substantially improve care for children at highest risk for asthma morbidity and we propose to establish (1) whether the positive effects of the ACE study can be replicated in a specific group of high-risk children with repeat ED visits; 2) whether the effects of the intervention can be enhanced by incorporating consistent clinician prompting to assure the provision of each component of guideline-based asthma care (ICS use, asthma action plan, and sustaining regular follow-up care to monitor asthma control); and 3)whether families not achieving optimal care will respond to a more intensive tiered intervention. We propose a caregiver and clinician prompting/feedback intervention using a pediatric asthma alert leader (PAAL) nurse to
1) organize and relay critical, individualized child health information from the ED and home setting to the PCP in a feedback letter, 2) ensure child and caregiver attendance at the follow-up visit with the PCP and 3) empower the family and prompt the PCP for guideline-based treatment decisions at the PCP visit. We hypothesize that the PAAL intervention will improve preventive care and reduce morbidity and health care costs for high-risk children with asthma compared to a Standard Asthma Education (SAE) control group.
Ages Eligible for Study: | 3 Years to 10 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All 6 criteria must be met:
Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following:
Exclusion Criteria:
Contact: Arlene M Butz, ScD, RN | 410-614-5963 | abutz@jhmi.edu |
Contact: Cassia L Land, MHS | 443-287-1060 | clewis4@jhmi.edu |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21287 | |
Contact: Arlene M Butz, ScD, RN 410-614-5963 abutz@jhmi.edu | |
Contact: Cassia L Land, MHS 443-287-1060 clewis4@jhmi.edu | |
Principal Investigator: Arlene M Butz, ScD, RN |
Principal Investigator: | Arlene M Butz, ScD, RN | Johns Hopkins University |
Responsible Party: | Johns Hopkins University ( Arlene Butz, ScD, RN Professor ) |
Study ID Numbers: | NR010546 |
Study First Received: | March 11, 2009 |
Last Updated: | March 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00860418 History of Changes |
Health Authority: | United States: Institutional Review Board |
asthma feedback anti-inflammatory ED visits |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |
Hypersensitivity Lung Diseases, Obstructive Immune System Diseases Respiratory Tract Diseases Bronchial Diseases |
Lung Diseases Hypersensitivity, Immediate Asthma Respiratory Hypersensitivity |