- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01168635
Improving Asthma Outcomes Through Spirometry Distance Learning
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few providers report its routine use for children with asthma. Misclassification of asthma severity occurs when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment, increased morbidity, and increased healthcare utilization/cost.
The goal of this study is to test the effectiveness of a distance learning quality improvement program called Spirometry 360 developed by the interactive Medical Training Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry 360 program aims to improve care for children with asthma by enhancing provider knowledge and self-efficacy related to the use and interpretation of office-based spirometry.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Spirometry 360 program includes:
- "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
- Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
- Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic.
This is a cluster randomized controlled trial to test the effectiveness of the Spirometry 360 program. The Spirometry 360 program will be provided to 25 primary care pediatric practices from two practice-based research networks. A separate group of 25 matched control practices recruited from these same networks will receive standard training from the equipment vendor during the study and the Spirometry 360 training program at the end of the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Slone Center Office-based Research Network (SCOR) - Boston University
-
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Washington
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Seattle, Washington, United States, 98101
- Seattle Children's Hospital Research Institute
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Seattle, Washington, United States, 98195
- Child Health Institute - Unversity of Washington
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Seattle, Washington, United States, 98195
- Puget Sound Pediatric Research Network
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria (Parent):
- Parents must have a child who has had at least one visit for asthma with a participating provider during the 12 months before the study start date
- Must have monthly access to email and the Internet
- Must have child aged 5-16 years
Inclusion Criteria (Child):
- Aged 5-16 years
- Must have access to email and the Internet
Exclusion Criteria (Parents):
- Parents with children who are outside our target age range of 5-16 years old
- Parents with children who haven't had a clinic visit for asthma care in the last year
- Parents without monthly access to the Internet
Exclusion Criteria (Child):
- Children who are outside our target age range of 5-16 years
- Children without monthly access to email and the Internet
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
|
|
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Experimental: Intervention
Virtually-delivered spirometry quality improvement program
|
The Spirometry 360 program includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Healthcare utilization
Time Frame: Assessed monthly for 1 year
|
Parent report of number of Emergency Room/Emergency Department (ER/ED) visits, unplanned outpatient visits, and number of hospitalizations due to asthma in the last month.
|
Assessed monthly for 1 year
|
|
Cost of asthma care
Time Frame: Every 6 months
|
Cost in inflation-adjusted dollars for unplanned healthcare utilization due to asthma exacerbation, including unplanned office visits, ED visits, and asthma-related hospitalization.
|
Every 6 months
|
|
Asthma-specific health-related quality of life
Time Frame: Every 6 months
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Parent report of child's asthma-specific health-related quality of life.
Measured using )Pediatric Quality of Life Inventory (PedsQL)(TM) 3.0 Short Form (SF)-22 Asthma Module.
The tool consists of an 11-item symptoms scale and an 11-item treatment problems scale.
|
Every 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptable spirometry testing sessions
Time Frame: Assessed monthly for 1 year
|
Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
|
Assessed monthly for 1 year
|
|
Appropriate prescription of controller therapy
Time Frame: Assessed monthly for 1 year
|
Parent/child report asthma symptoms and unplanned health care utilization consistent with persistent/uncontrolled asthma AND patient has been prescribed a controller medication.
|
Assessed monthly for 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rita Mangione-Smith, MD, MPH, Seattle Children's Hospital/University of Washington
Publications and 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
- 13169
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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