Clinical trial NCT01152320: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Spirometry
Pediatric
Primary Health Care
Education, Distance
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Spirometry test quality
timeFrame: Four months for controls; six months for intervention sites
Secondary outcomes:
measure: Effect of frequency of spirometry use on primary outcome
timeFrame: Four months for controls; six months for intervention sites
measure: Effect of practice location on primary outcome
timeFrame: Four months for controls; six months for intervention sites
measure: Effect of practice type on primary outcome
timeFrame: Four months for controls; six months for intervention sites
measure: Effect of practice structure on primary outcome
timeFrame: Four months for controls; six months for intervention sites
measure: Effect of months of spirometry use on primary outcome
timeFrame: Four months for controls; six months for intervention sites
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington/Seattle Children's Hospital
name: Rita Mangione-Smith, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: James W Stout, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: