Trial of Spirometry Fundamentals™ in the Primary Care Setting
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spirometry Fundamentals™ Training CD
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
Eligibility Criteria
Inclusion Criteria:
- Subjects must have internet access in order to transmit spirometry curve and survey data.
- Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
- Subjects must have access to a ndd Easyone spirometer.
Exclusion Criteria:
- Subjects who lack internet access which will be needed to transmit study data
- Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
- Subjects who lack access to a ndd Easyone spirometer.
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard of Care
Intervention
Arm Description
Spirometry Fundamentals™ CD training program
Outcomes
Primary Outcome Measures
Spirometry test quality
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
Secondary Outcome Measures
Effect of frequency of spirometry use on primary outcome
Examined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
Effect of practice location on primary outcome
Examined whether practice location (private/community, hospital/university) related to the percent of passing testing sessions conducted by the office.
Effect of practice type on primary outcome
Examined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
Effect of practice structure on primary outcome
Examined whether practice structure related to the percent of passing testing sessions conducted by the office.
Effect of months of spirometry use on primary outcome
Examined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01152320
Brief Title
Trial of Spirometry Fundamentals™ in the Primary Care Setting
Official Title
Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Misclassification of asthma severity has been reported when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment that may result in increased morbidity and increased healthcare utilization/cost. However, even when spirometry is utilized 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 the Spirometry Fundamentals™ tool in training primary care providers and their staff in producing high-quality flow-volume curves as compared to existing training modalities and to gather information in a 'real-world' setting that can be used to improve Spirometry Fundamentals™.
Detailed Description
Currently few self-paced, distance learning programs exist that train staff to perform good quality spirometry tests. This study evaluates the effectiveness of a distance-learning tool for training primary care providers and their medical assistants in the use of spirometry to assist in managing obstructive lung disease (asthma and COPD). This tool is called "Spirometry Fundamentals™: A basic guide to lung function testing". It is a computer-based training program that teaches primary care providers and their staff what spirometry is, how it can be used, the techniques required to perform high-quality spirometry, and clinical interpretation of the spirometric data.
We evaluated the effectiveness of Spirometry Fundamentals in the primary care setting by conducting a randomized controlled trial (RCT). Study participants were primary care physicians (MDs or DOs) and their staff (medical assistants (MAs) or nurses (RNs)) and were recruited as study pairs. The role of the MDs was to utilize spirometry in clinical care by ordering spirometry tests based on their clinical judgment, and the role of the MAs was to perform the spirometry. The patients performed the spirometry as part of their usual care were not considered study subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Spirometry Fundamentals™ CD training program
Intervention Type
Behavioral
Intervention Name(s)
Spirometry Fundamentals™ Training CD
Intervention Description
MD-MA pairs randomized to the intervention arm of the study received 2 copies of the Spirometry Fundamentals™ CD. Included with the CDs was a letter explaining that each member of the MD-MA pair should view the CD at their convenience within the following 3 weeks. This letter included instructions on how to access the study website in order to complete an evaluation survey after viewing the CD.
Primary Outcome Measure Information:
Title
Spirometry test quality
Description
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
Time Frame
Four months for controls; six months for intervention sites
Secondary Outcome Measure Information:
Title
Effect of frequency of spirometry use on primary outcome
Description
Examined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
Time Frame
Four months for controls; six months for intervention sites
Title
Effect of practice location on primary outcome
Description
Examined whether practice location (private/community, hospital/university) related to the percent of passing testing sessions conducted by the office.
Time Frame
Four months for controls; six months for intervention sites
Title
Effect of practice type on primary outcome
Description
Examined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
Time Frame
Four months for controls; six months for intervention sites
Title
Effect of practice structure on primary outcome
Description
Examined whether practice structure related to the percent of passing testing sessions conducted by the office.
Time Frame
Four months for controls; six months for intervention sites
Title
Effect of months of spirometry use on primary outcome
Description
Examined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.
Time Frame
Four months for controls; six months for intervention sites
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects must have internet access in order to transmit spirometry curve and survey data.
Subjects must have access to a computer with Windows 2000 /Mac OS 10 or higher in order to view Spirometry Fundamentals™.
Subjects must have access to a ndd Easyone spirometer.
Exclusion Criteria:
Subjects who lack internet access which will be needed to transmit study data
Subjects who lack access to a computer with Windows 2000 /Mac OS 10 or higher which will be needed to view Spirometry Fundamentals™.
Subjects who lack access to a ndd Easyone spirometer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Mangione-Smith, MD, MPH
Organizational Affiliation
University of Washington/Seattle Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James W Stout, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.spirometrytraining.org/
Description
Site for primary care physicians to learn about Spirometry
Learn more about this trial
Trial of Spirometry Fundamentals™ in the Primary Care Setting
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