AsthmaNCT01152320
Trial of Spirometry Fundamentals™ in the Primary Care Setting
A study testing Spirometry Fundamentals™ Training CD in people with Asthma, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Spirometry Fundamentals™ Training CD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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™.
Read the 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.
- Conditions
- Asthma
- Being tested
- Spirometry Fundamentals™ Training CD
- Keywords
- Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spirometry Fundamentals™ Training CDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Not described |
| Intervention | Experimental | Spirometry Fundamentals™ CD training program Receives: Behavioral: Spirometry Fundamentals™ Training CD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry test quality
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
Measured: Four months for controls; six months for intervention sites
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Four months for controls; six months for intervention sites
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startMar 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Rita Mangione-Smith, MD, MPH, Principal investigator, University of Washington/Seattle Children's HospitalJames W Stout, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152320
- Sponsor's protocol ID
- 31552-E/A
- Other IDs
- A26829
- Status last verified
- Jun 2010
- First submitted
- 25 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Spirometry Fundamentals™ in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT01152320
- Acronym / sponsor ID
- 31552-E/A
- Conditions
- Asthma
- Keywords
- Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | – |
| Intervention | Experimental | Behavioral: Spirometry Fundamentals™ Training CDSpirometry Fundamentals™ CD training program |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spirometry Fundamentals™ Training CDMD-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. | Behavioural | Intervention |
Primary outcome
Spirometry test quality
Time frame: Four months for controls; six months for intervention sites
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
5 secondary outcomes
Effect of frequency of spirometry use on primary outcome
Time frame: Four months for controls; six months for intervention sites
Effect of practice location on primary outcome
Time frame: Four months for controls; six months for intervention sites
Effect of practice type on primary outcome
Time frame: Four months for controls; six months for intervention sites
Effect of practice structure on primary outcome
Time frame: Four months for controls; six months for intervention sites
Effect of months of spirometry use on primary outcome
Time frame: Four months for controls; six months for intervention sites
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Site for primary care physicians to learn about SpirometryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rita Mangione-Smith, MD, MPH principal investigator
University of Washington/Seattle Children's Hospital
James W Stout, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry Fundamentals™ Training CD in people with Asthma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry test quality (time frame: Four months for controls; six months for intervention sites). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010; AzTrials last refreshed its copy on 7 Nov 2026.