Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 11:46 AM
Study NCT ID:
NCT01161433
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2010-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2010-06-15', 'studyFirstSubmitQcDate': '2010-07-09', 'lastUpdatePostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spirometry test quality', 'timeFrame': 'Seven months', 'description': 'Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.'}], 'secondaryOutcomes': [{'measure': 'Presence of asthma care plan', 'timeFrame': 'Seven months', 'description': 'To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which written asthma action plans are completed.'}, {'measure': 'Asthma severity documentation', 'timeFrame': 'Seven months', 'description': 'To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which asthma severity is appropriately documented.'}, {'measure': 'Appropriate prescription of controller therapy', 'timeFrame': 'Seven months', 'description': 'To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which appropriate controller therapy is prescribed.'}, {'measure': 'Frequency of office-based spirometry', 'timeFrame': 'Seven months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Spirometry', 'Pediatric', 'Primary Health Care', 'Education, Distance'], 'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://depts.washington.edu/imtr/spiro360/', 'label': 'Spirometry 360 Training Program'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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:\n\n1. Spirometry Fundamentals™ CD-ROM;\n2. Case-based, interactive webinars; and\n3. an Internet-based spirometry quality feedback reporting system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internet access on a computer running Windows XP SP2\n* Access to a computer with Windows 2000 /Mac OS 10 or higher\n* Practices must match another enrolled practice on the following parameters.\n\n 1. Number of providers in practice (same number +/- 1 provider)\n 2. Location - both practices must either be urban or rural\n 3. % of patients eligible for Medicaid (same percentage +/- 15%)\n 4. Practice type (school-based clinic, Federally Qualified Health Center, private practice, hospital- or university-based clinic)\n 5. Geographic distance (minimum of 10 miles away from matched pair practice)\n\nExclusion Criteria:\n\n* Lack of Internet access on a computer running Windows XP SP2\n* Lack of access to a computer with Windows 2000 /Mac OS 10 or higher\n* Practices that were unable to be matched to another similar practice'}, 'identificationModule': {'nctId': 'NCT01161433', 'briefTitle': 'A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Implementing Evidence-based Quality Improvement Strategies to Improve Asthma Care for Children', 'orgStudyIdInfo': {'id': '32583-E/B'}, 'secondaryIdInfos': [{'id': 'HHSA290200600022, Task order 2', 'type': 'OTHER_GRANT', 'domain': 'Agency for Healthcare Research and Quality'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Virtually delivered spirometry quality improvement program', 'interventionNames': ['Behavioral: Virtually delivered spirometry quality improvement program']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care'}], 'interventions': [{'name': 'Virtually delivered spirometry quality improvement program', 'type': 'BEHAVIORAL', 'description': 'Sites in the intervention arm receive the virtually delivered QI program.\n\nThe program includes:\n\n1. Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data;\n2. Case-based, interactive webinars; and\n3. an Internet-based spirometry quality feedback reporting system.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James W Stout, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Rita Mangione-Smith, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Washington/Seattle Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'James W. Stout/Principal Investigator', 'oldOrganization': 'University of Washington'}}}}