Trial of Spirometry Fundamentals™ in the Primary Care Setting

NCT01152320 | Completed

• 2 other identifiers: 31552-E/AA26829
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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™.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effect of frequency of spirometry use on primary outcome

  Four months for controls; six months for intervention sites

• Effect of practice location on primary outcome

  Four months for controls; six months for intervention sites

• Effect of practice type on primary outcome

  Four months for controls; six months for intervention sites

• Effect of practice structure on primary outcome

  Four months for controls; six months for intervention sites

• Effect of months of spirometry use on primary outcome

  Four months for controls; six months for intervention sites

Study Arms (2)

Standard of Care

NO INTERVENTION

Intervention

EXPERIMENTAL

Spirometry Fundamentals™ CD training program

Behavioral: Spirometry Fundamentals™ Training CD

Interventions

Spirometry Fundamentals™ Training CD BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Links

• Site for primary care physicians to learn about Spirometry

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Rita Mangione-Smith, MD, MPH

  University of Washington/Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

• James W Stout, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 25, 2010
• First Posted: June 29, 2010
• Study Start: March 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 29, 2010

Record last verified: 2010-06

Locations

US (1)