Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)

August 31, 2015 updated by: Arlene M. Butz, Johns Hopkins University

Pediatric Asthma Alert Intervention for Minority Children

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:

  1. Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group.
  2. Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All 6 criteria must be met:

  1. Physician-diagnosed asthma (based on caregiver report with validation from the child's physician)
  2. > 2 ED visits or > 1 hospitalization for asthma within past 12 months

  3. Mild persistent to severe persistent asthma based on NHLBI guidelines criteria (7-9) having any 1 of the following:

    • An average of > 2 days per week of asthma symptoms
    • > 2 days per week with rescue medication use (albuterol, xopenex) OR
    • > 2 days per month of nighttime symptoms
  4. Age > 3 and < 10 years
  5. Reside in Baltimore Metropolitan area
  6. Not currently participating in another asthma study or sibling enrolled in PAAL study

Exclusion Criteria:

  1. Inability to speak and understand English
  2. No access to a working phone or alternate phone for follow-up surveys
  3. Co-morbid respiratory condition including cystic fibrosis, chronic lung disease (BPD), lung cancer, tracheostomy that could interfere with the assessment of asthma-related outcome measures.
  4. Children residing in foster care or where consent cannot be obtained from a legal guardian.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Standard asthma education delivered during 2 home visits by a nurse.
Behavioral: Standard asthma education
Standard asthma education during 2 home visits.
Other Names:
  • Asthma Education
Experimental: 2 PAAL
PAAL
Behavioral: Pediatric Asthma Alert (PAAL)
Asthma nurse conducts 2 home visits and accompanies the child to primary care provider visit after ED visits
Other Names:
  • Pediatric Asthma Alert Leader (Nurse)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of primary care appointments kept over 12 months
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of refills for anti-inflammatory medications prescribed over 12 months
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Maryland
University of Rochester

Investigators

  • Principal Investigator: Arlene M Butz, ScD, RN, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 11, 2009

First Submitted That Met QC Criteria

March 11, 2009

First Posted (Estimate)

March 12, 2009

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR010546

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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