Improving Asthma Outcomes Through Spirometry Distance Learning
| Tracking Information | |||||
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| First Received Date ICMJE | July 20, 2010 | ||||
| Last Updated Date | June 27, 2011 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01168635 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Improving Asthma Outcomes Through Spirometry Distance Learning | ||||
| Official Title ICMJE | Improving Asthma Outcomes Through Spirometry Distance Learning | ||||
| Brief Summary | 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. |
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| Detailed Description | The Spirometry 360 program includes:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program
The Spirometry 360 program includes:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria (Parent):
Inclusion Criteria (Child):
Exclusion Criteria (Parents):
Exclusion Criteria (Child):
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01168635 | ||||
| Other Study ID Numbers ICMJE | 13169 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Rita Mangione-Smith, Seattle Children's Hospital | ||||
| Study Sponsor ICMJE | Seattle Children's Hospital | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Seattle Children's Hospital | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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