Trial of Spirometry Fundamentals™ in the Primary Care Setting

This study has been completed.
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01152320
First received: June 25, 2010
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

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™.


Condition Intervention
Asthma
Behavioral: Spirometry Fundamentals™ Training CD

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Spirometry test quality [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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 [ Time Frame: Four months for controls; six months for intervention sites ] [ Designated as safety issue: No ]
    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.


Enrollment: 52
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152320

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Rita Mangione-Smith, University of Washington/Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01152320     History of Changes
Other Study ID Numbers: 31552-E/A, A26829
Study First Received: June 25, 2010
Last Updated: June 28, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Asthma
Spirometry
Pediatric
Primary Health Care
Education, Distance

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014