AsthmaNCT01161433
A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting
A study testing Virtually delivered spirometry quality improvement program 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, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. 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?
- Virtually delivered spirometry quality improvement program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Sep 2008
- 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
- Internet access on a computer running Windows XP SP2
- Access to a computer with Windows 2000 /Mac OS 10 or higher
- Practices must match another enrolled practice on the following parameters.
- Number of providers in practice (same number +/- 1 provider)
- Location - both practices must either be urban or rural
- % of patients eligible for Medicaid (same percentage +/- 15%)
- Practice type (school-based clinic, Federally Qualified Health Center, private practice, hospital- or university-based clinic)
- Geographic distance (minimum of 10 miles away from matched pair practice)
Who cannot join
- Lack of Internet access on a computer running Windows XP SP2
- Lack of access to a computer with Windows 2000 /Mac OS 10 or higher
- Practices that were unable to be matched to another similar practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing Evidence-based Quality Improvement Strategies to Improve Asthma Care for Children
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used 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 a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.
Read the detailed description
A cluster randomized trial with matched practice pairs. All practices receive a spirometer and standard vendor training. Those randomized to the intervention group receive a 7-month QI program, which includes:
- Spirometry Fundamentals™ CD-ROM;
- Case-based, interactive webinars; and
- an Internet-based spirometry quality feedback reporting system.
- Conditions
- Asthma
- Being tested
- Virtually delivered spirometry quality improvement program
- 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.
Virtually delivered spirometry quality improvement programBehavioural
Sites in the intervention arm receive the virtually delivered QI program.
The program includes:
- Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data;
- Case-based, interactive webinars; and
- an Internet-based spirometry quality feedback reporting system.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Virtually delivered spirometry quality improvement program Receives: Behavioral: Virtually delivered spirometry quality improvement program |
| Standard of Care | No intervention | Not described |
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: Seven months
Secondary outcomes (4)
Presence of asthma care plan
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which written asthma action plans are completed.
Measured: Seven months
Asthma severity documentation
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which asthma severity is appropriately documented.
Measured: Seven months
Appropriate prescription of controller therapy
To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which appropriate controller therapy is prescribed.
Measured: Seven months
Frequency of office-based spirometry
To test whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which office-based spirometry is used in the management of children with asthma.
Measured: Seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startOct 2007
- Primary completionSep 2008
- Study completionSep 2008
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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- James W Stout, MD, MPH, Principal investigator, University of WashingtonRita Mangione-Smith, MD, MPH, Principal investigator, University of Washington/Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161433
- Sponsor's protocol ID
- 32583-E/B
- Other IDs
- HHSA290200600022, Task order 2
- Status last verified
- Jul 2010
- First submitted
- 15 Jun 2010
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Evidence-based Quality Improvement Strategies to Improve Asthma Care for Children
- ClinicalTrials.gov ID
- NCT01161433
- Acronym / sponsor ID
- 32583-E/B
- Conditions
- Asthma
- Keywords
- Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jul 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, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used 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 a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.
Detailed description
A cluster randomized trial with matched practice pairs. All practices receive a spirometer and standard vendor training. Those randomized to the intervention group receive a 7-month QI program, which includes:
- Spirometry Fundamentals™ CD-ROM;
- Case-based, interactive webinars; and
- an Internet-based spirometry quality feedback reporting system.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Virtually delivered spirometry quality improvement programVirtually delivered spirometry quality improvement program |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Internet access on a computer running Windows XP SP2
- Access to a computer with Windows 2000 /Mac OS 10 or higher
- Practices must match another enrolled practice on the following parameters.
Key exclusion criteria (3 listed)
- Lack of Internet access on a computer running Windows XP SP2
- Lack of access to a computer with Windows 2000 /Mac OS 10 or higher
- Practices that were unable to be matched to another similar practice
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 |
|---|---|---|
| Virtually delivered spirometry quality improvement programSites in the intervention arm receive the virtually delivered QI program. The program includes: 1. Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data; 2. Case-based, interactive webinars; and 3. an Internet-based spirometry quality feedback reporting system. | Behavioural | Intervention |
Primary outcome
Spirometry test quality
Time frame: Seven months
Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.
4 secondary outcomes
Presence of asthma care plan
Time frame: Seven months
Asthma severity documentation
Time frame: Seven months
Appropriate prescription of controller therapy
Time frame: Seven months
Frequency of office-based spirometry
Time frame: Seven months
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 13 Jul 2010.
- Spirometry 360 Training ProgramLink 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.
James W Stout, MD, MPH principal investigator
University of Washington
Rita Mangione-Smith, MD, MPH principal investigator
University of Washington/Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually delivered spirometry quality improvement program 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 8 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 13 Jul 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: Seven months). 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 13 Jul 2010; AzTrials last refreshed its copy on 29 Oct 2026.