Evaluating a Pediatric Asthma Management Education Program for Physicians

Asthma Clinical Trial

Official title:

Enhancing Pediatric Asthma Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399984
• Other study ID #: 437
• Secondary ID: R01HL070771
• Status: Completed
• Phase: N/A
• First received: November 13, 2006
• Last updated: June 11, 2013
• Start date: April 2004
• Est. completion date: June 2009

Study information

• Verified date: June 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Asthma
• Education, Medical

Intervention

Behavioral:
• Asthma Education Program
interactive seminars regarding daily inhaled corticosteroids

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in physician knowledge, attitudes, and self-reported behavior		1-3 years	No
Primary	Changes in patient asthma outcomes (both measured on a yearly basis)		1-3 years	No