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Trial of Spirometry Fundamentals™ in the Primary Care Setting

Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01152320
Enrollment
52
Registered
2010-06-29
Start date
2007-03-31
Completion date
2009-05-31
Last updated
2010-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance

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.

Interventions

BEHAVIORALSpirometry Fundamentals™ Training CD

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.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Spirometry test qualityFour months for controls; six months for intervention sitesPercentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.

Secondary

MeasureTime frameDescription
Effect of frequency of spirometry use on primary outcomeFour months for controls; six months for intervention sitesExamined whether frequency of spirometry use related to the percent of passing testing sessions conducted by the office.
Effect of practice location on primary outcomeFour months for controls; six months for intervention sitesExamined 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 outcomeFour months for controls; six months for intervention sitesExamined whether practice type (pediatric/non-pediatric) related to the percent of passing testing sessions conducted by the office.
Effect of practice structure on primary outcomeFour months for controls; six months for intervention sitesExamined whether practice structure related to the percent of passing testing sessions conducted by the office.
Effect of months of spirometry use on primary outcomeFour months for controls; six months for intervention sitesExamined whether months of spirometry use by practice (prior to participating in study) related to the percent of passing testing sessions conducted by the office.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026