Improving Asthma Outcomes Through Spirometry Distance Learning
This study is ongoing, but not recruiting participants.
Sponsor:
Seattle Children's Hospital
Collaborators:
University of Washington
Boston University
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01168635
First received: July 20, 2010
Last updated: June 27, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Asthma Outcomes Through Spirometry Distance Learning |
Resource links provided by NLM:
Further study details as provided by Seattle Children's Hospital:
Primary Outcome Measures:
- Healthcare utilization [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]Parent report of number of ER/ED visits, unplanned outpatient visits, and number of hospitalizations due to asthma in the last month.
- Cost of asthma care [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]Cost in inflation-adjusted dollars for unplanned healthcare utilization due to asthma exacerbation, including unplanned office visits, ED visits, and asthma-related hospitalization.
- Asthma-specific health-related quality of life [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]Parent report of child's asthma-specific health-related quality of life. Measured using PedsQL(TM) 3.0 SF-22 Asthma Module. The tool consists of an 11-item symptoms scale and an 11-item treatment problems scale.
Secondary Outcome Measures:
- Acceptable spirometry testing sessions [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
- Appropriate prescription of controller therapy [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]Parent/child report asthma symptoms and unplanned health care utilization consistent with persistent/uncontrolled asthma AND patient has been prescribed a controller medication.
| Estimated Enrollment: | 1500 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Virtually-delivered spirometry quality improvement program
|
Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program
The Spirometry 360 program includes:
|
| No Intervention: Standard of Care |
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.
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168635
Locations
| United States, Massachusetts | |
| Slone Center Office-based Research Network (SCOR) - Boston University | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Washington | |
| Seattle Children's Hospital Research Institute | |
| Seattle, Washington, United States, 98101 | |
| Puget Sound Pediatric Research Network | |
| Seattle, Washington, United States, 98195 | |
| Child Health Institute - Unversity of Washington | |
| Seattle, Washington, United States, 98195 | |
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Boston University
Investigators
| Principal Investigator: | Rita Mangione-Smith, MD, MPH | Seattle Children's Hospital/University of Washington |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rita Mangione-Smith, Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01168635 History of Changes |
| Other Study ID Numbers: | 13169 |
| Study First Received: | July 20, 2010 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Seattle Children's Hospital:
|
Asthma Spirometry Pediatric Primary Health Care Education, Distance |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013