Evaluating a Pediatric Asthma Management Education Program for Physicians

June 11, 2013 updated by: University of California, San Francisco

Enhancing Pediatric Asthma Management

Inhaled corticosteroids taken on a daily basis have been proven to be the most effective treatment for children with persistent asthma. However, many pediatricians still do not prescribe daily corticosteroids to their asthmatic patients; this can lead to poor health outcomes among asthmatic children. This study will evaluate an interactive medical education program that focuses on improving pediatricians' asthma management skills and on encouraging increased corticosteroid use among their patients with asthma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asthma is a common childhood disease that affects over 9 million children in the United States. In 1997, the National Heart, Lung, and Blood Institute (NHLBI) published a set of guidelines aimed at improving the quality of patient care for individuals with asthma. According to the guidelines, a daily dose of inhaled corticosteroids is considered the most effective treatment for the long-term control of asthma. Despite this recommendation, many pediatricians are not prescribing daily corticosteroids to asthmatic children who may benefit from this treatment.

Continuing medical education (CME) is viewed as the primary method of keeping health care providers informed of new research knowledge and the latest medical trends. While traditional CME programs have not been successful in changing physician behavior, an interactive program that offers skills development for implementing changes in the care and treatment of asthmatic patients may prove effective. The purpose of this study is to develop, implement, and evaluate an interactive asthma education program targeted towards pediatricians. Specifically, the study will determine the program's effectiveness at developing asthma management skills in pediatricians, including corticosteroid prescribing practices, and improving asthma-related outcomes among their pediatric patients.

In this 5-year study, pediatricians will be randomly assigned to either an asthma education intervention group or a control group. The intervention group will attend the enhanced asthma education seminar, and the control group will attend a traditional lecture about asthma. In Years 1 and 2, the intervention group will participate in a 2-hour focus group to discuss barriers to adopting the NHLBI asthma guidelines for daily corticosteroid therapy. A brief survey on this same topic will also be completed. During Year 2, physicians in the intervention group will attend at least 5 hours of educational seminars designed to improve adherence to the recommended guidelines. In Years 2 through 5, all physicians will complete yearly questionnaires to assess barriers to corticosteroid prescription methods. Parents of asthmatic patients treated by the pediatricians will take part in a 20-minute telephone survey each year, and study researchers will review the medical records of each child.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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
    • California
      • San Francisco, California, United States, 94118
        • University of California, San Francisco

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Pediatricians must meet all of the following criteria:

    1. Graduate of a pediatric residency program in the United States
    2. In active medical practice for at least 4 half-day sessions, with 40% clinical effort in general pediatrics
    3. At least 54 children with asthma in their patient population

  • Parents of pediatric asthma patients must meet all of the following criteria:

    1. Parent or guardian of a pediatric patient that meets patient eligibility criteria
    2. Able to identify that the participating physician is the child's primary care pediatrician
    3. Provides most asthma management or is the adult who normally takes the child to the doctor

  • Pediatric patients must meet all of the following criteria:

    1. Older than 4 years of age (to decrease the likelihood that the child has bronchiolitis)
    2. Younger than 16 years of age (to ensure that during all 3 years of the evaluation part of the study, the child will be younger than 20 years of age)
    3. Diagnosis of asthma made by a physician using commonly accepted clinical criteria
    4. No other chronic disorders that have pulmonary complications (e.g., sickle cell disease, tuberculosis, acquired immune deficiency syndrome [AIDS], cystic fibrosis)

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: Asthma Education Program
interactive seminars regarding daily inhaled corticosteroids
No Intervention: 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in physician knowledge, attitudes, and self-reported behavior
Time Frame: 1-3 years
1-3 years
Changes in patient asthma outcomes (both measured on a yearly basis)
Time Frame: 1-3 years
1-3 years

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Michael D. Cabana, MD, MPH, University of California, San Francisco

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

April 1, 2004

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 13, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (Estimate)

November 15, 2006

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 437
  • R01HL070771 (U.S. NIH Grant/Contract)

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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