Trial of Spirometry Fundamentals™ in the Primary Care Setting

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

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™.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Behavioral: Spirometry Fundamentals™ Training CD

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Intervention; Spirometry Fundamentals™ CD training program	Behavioral: Spirometry 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spirometry test quality	Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.	Four months for controls; six months for intervention sites

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four months for controls; six months for intervention sites
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.	Four months for controls; six months for intervention sites
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.	Four months for controls; six months for intervention sites
Effect of practice structure on primary outcome	Examined whether practice structure related to the percent of passing testing sessions conducted by the office.	Four months for controls; six months for intervention sites
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.	Four months for controls; six months for intervention sites

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Rita Mangione-Smith, MD, MPH, University of Washington/Seattle Children's Hospital; Principal Investigator: James W Stout, MD, MPH, University of Washington

Publications and helpful links

Helpful Links

• Site for primary care physicians to learn about Spirometry

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): June 29, 2010
• Last Update Submitted That Met QC Criteria: June 28, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Asthma; Pediatric; Primary Health Care; Spirometry; Education, Distance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 31552-E/A; A26829 (Other Grant/Funding Number: American Thoracic Society)