- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01161433
A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting
Implementing Evidence-based Quality Improvement Strategies to Improve Asthma Care for Children
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.
The goal of this study is to evaluate the effectiveness of a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A cluster randomized trial with matched practice pairs. All practices receive a spirometer and standard vendor training. Those randomized to the intervention group receive a 7-month QI program, which includes:
- Spirometry Fundamentals™ CD-ROM;
- Case-based, interactive webinars; and
- an Internet-based spirometry quality feedback reporting system.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Internet access on a computer running Windows XP SP2
- Access to a computer with Windows 2000 /Mac OS 10 or higher
Practices must match another enrolled practice on the following parameters.
- Number of providers in practice (same number +/- 1 provider)
- Location - both practices must either be urban or rural
- % of patients eligible for Medicaid (same percentage +/- 15%)
- Practice type (school-based clinic, Federally Qualified Health Center, private practice, hospital- or university-based clinic)
- Geographic distance (minimum of 10 miles away from matched pair practice)
Exclusion Criteria:
- Lack of Internet access on a computer running Windows XP SP2
- Lack of access to a computer with Windows 2000 /Mac OS 10 or higher
- Practices that were unable to be matched to another similar practice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
|
|
Experimental: Intervention
Virtually delivered spirometry quality improvement program
|
Sites in the intervention arm receive the virtually delivered QI program. The program includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spirometry test quality
Time Frame: Seven months
|
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
|
Seven months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of asthma care plan
Time Frame: Seven months
|
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which written asthma action plans are completed.
|
Seven months
|
Asthma severity documentation
Time Frame: Seven months
|
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which asthma severity is appropriately documented.
|
Seven months
|
Appropriate prescription of controller therapy
Time Frame: Seven months
|
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which appropriate controller therapy is prescribed.
|
Seven months
|
Frequency of office-based spirometry
Time Frame: Seven months
|
To test whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which office-based spirometry is used in the management of children with asthma.
|
Seven months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rita Mangione-Smith, MD, MPH, University of Washington/Seattle Children's Hospital
- Principal Investigator: James W Stout, MD, MPH, University of Washington
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32583-E/B
- HHSA290200600022, Task order 2 (Other Grant/Funding Number: Agency for Healthcare Research and Quality)
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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