AsthmaNCT01168635
Improving Asthma Outcomes Through Spirometry Distance Learning
A study testing Spirometry 360 program - Virtually-delivered spirometry quality improvement program in people with Asthma, run by Seattle Children's Hospital at 4 sites in United States.
Trial summary
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few providers report its routine use for children with asthma. Misclassification of asthma severity occurs when assessment is based on symptoms alone. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Spirometry 360 program - 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
- 660 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Jan 2012
- 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents must have a child who has had at least one visit for asthma with a participating provider during the 12 months before the study start date
- Must have monthly access to email and the Internet
- Must have child aged 5-16 years
- Aged 5-16 years
- Must have access to email and the Internet
Who cannot join
- Parents with children who are outside our target age range of 5-16 years old
- Parents with children who haven't had a clinic visit for asthma care in the last year
- Parents without monthly access to the Internet
- Children who are outside our target age range of 5-16 years
- Children without monthly access to email and the Internet
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Slone Center Office-based Research Network (SCOR) - Boston University
Boston, Massachusetts, 02215
Seattle Children's Hospital Research Institute
Seattle, Washington, 98101
Child Health Institute - Unversity of Washington
Seattle, Washington, 98195
Puget Sound Pediatric Research Network
Seattle, Washington, 98195
About this study
Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, yet few providers report its routine use for children with asthma. Misclassification of asthma severity occurs when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment, increased morbidity, and increased healthcare utilization/cost.
The goal of this study is to test the effectiveness of a distance learning quality improvement program called Spirometry 360 developed by the interactive Medical Training Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry 360 program aims to improve care for children with asthma by enhancing provider knowledge and self-efficacy related to the use and interpretation of office-based spirometry.
Read the detailed description
The Spirometry 360 program includes:
- "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
- Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
- Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic.
This is a cluster randomized controlled trial to test the effectiveness of the Spirometry 360 program. The Spirometry 360 program will be provided to 25 primary care pediatric practices from two practice-based research networks. A separate group of 25 matched control practices recruited from these same networks will receive standard training from the equipment vendor during the study and the Spirometry 360 training program at the end of the study.
- Conditions
- Asthma
- Being tested
- Spirometry 360 program - 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.
Spirometry 360 program - Virtually-delivered spirometry quality improvement programBehavioural
The Spirometry 360 program includes:
- "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
- Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
- Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Virtually-delivered spirometry quality improvement program Receives: Behavioral: Spirometry 360 program - 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.
Healthcare utilization
Parent report of number of Emergency Room/Emergency Department (ER/ED) visits, unplanned outpatient visits, and number of hospitalizations due to asthma in the last month.
Measured: Assessed monthly for 1 year
Cost of asthma care
Cost in inflation-adjusted dollars for unplanned healthcare utilization due to asthma exacerbation, including unplanned office visits, ED visits, and asthma-related hospitalization.
Measured: Every 6 months
Asthma-specific health-related quality of life
Parent report of child's asthma-specific health-related quality of life. Measured using )Pediatric Quality of Life Inventory (PedsQL)(TM) 3.0 Short Form (SF)-22 Asthma Module. The tool consists of an 11-item symptoms scale and an 11-item treatment problems scale.
Measured: Every 6 months
Secondary outcomes (2)
Acceptable spirometry testing sessions
Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
Measured: Assessed monthly for 1 year
Appropriate prescription of controller therapy
Parent/child report asthma symptoms and unplanned health care utilization consistent with persistent/uncontrolled asthma AND patient has been prescribed a controller medication.
Measured: Assessed monthly for 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2012
- Study completionJan 2012
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.
- 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
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Boston University
- Responsible party
- Principal investigator, Rita Mangione-Smith, Seattle Children's Hospital
- Investigators
- Rita Mangione-Smith, MD, MPH, Principal investigator, Seattle Children's Hospital/University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168635
- Sponsor's protocol ID
- 13169
- Status last verified
- May 2015
- First submitted
- 20 Jul 2010
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Asthma Outcomes Through Spirometry Distance Learning
- ClinicalTrials.gov ID
- NCT01168635
- Acronym / sponsor ID
- 13169
- Conditions
- Asthma
- Keywords
- Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington, Boston University
- Study start
- Jun 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 23 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, yet few providers report its routine use for children with asthma. Misclassification of asthma severity occurs when assessment is based on symptoms alone. This misclassification can lead to inadequate treatment, increased morbidity, and increased healthcare utilization/cost.
The goal of this study is to test the effectiveness of a distance learning quality improvement program called Spirometry 360 developed by the interactive Medical Training Resources (iMTR) group at the University of Washington Child Health Institute. The Spirometry 360 program aims to improve care for children with asthma by enhancing provider knowledge and self-efficacy related to the use and interpretation of office-based spirometry.
Detailed description
The Spirometry 360 program includes:
- "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
- Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
- Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic.
This is a cluster randomized controlled trial to test the effectiveness of the Spirometry 360 program. The Spirometry 360 program will be provided to 25 primary care pediatric practices from two practice-based research networks. A separate group of 25 matched control practices recruited from these same networks will receive standard training from the equipment vendor during the study and the Spirometry 360 training program at the end of the study.
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: Spirometry 360 program - Virtually-delivered spirometry quality improvement programVirtually-delivered spirometry quality improvement program |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parents must have a child who has had at least one visit for asthma with a participating provider during the 12 months before the study start date
- Must have monthly access to email and the Internet
- Must have child aged 5-16 years
- Aged 5-16 years
- Must have access to email and the Internet
Key exclusion criteria (5 listed)
- Parents with children who are outside our target age range of 5-16 years old
- Parents with children who haven't had a clinic visit for asthma care in the last year
- Parents without monthly access to the Internet
- Children who are outside our target age range of 5-16 years
- Children without monthly access to email and the Internet
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 360 program - Virtually-delivered spirometry quality improvement programThe Spirometry 360 program includes: 1. "Spirometry Fundamentals™: A basic guide to lung function testing," a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data; 2. Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review; 3. Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic. | Behavioural | Intervention |
Primary outcome
Healthcare utilization
Time frame: Assessed monthly for 1 year
Parent report of number of Emergency Room/Emergency Department (ER/ED) visits, unplanned outpatient visits, and number of hospitalizations due to asthma in the last month.
Cost of asthma care
Time frame: Every 6 months
Cost in inflation-adjusted dollars for unplanned healthcare utilization due to asthma exacerbation, including unplanned office visits, ED visits, and asthma-related hospitalization.
Asthma-specific health-related quality of life
Time frame: Every 6 months
Parent report of child's asthma-specific health-related quality of life. Measured using )Pediatric Quality of Life Inventory (PedsQL)(TM) 3.0 Short Form (SF)-22 Asthma Module. The tool consists of an 11-item symptoms scale and an 11-item treatment problems scale.
2 secondary outcomes
Acceptable spirometry testing sessions
Time frame: Assessed monthly for 1 year
Appropriate prescription of controller therapy
Time frame: Assessed monthly for 1 year
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 20 May 2015.
- Site for primary care physicians to learn about SpirometryLink provided by the sponsor.
Related trials for Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
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
Seattle Children's Hospital/University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spirometry 360 program - Virtually-delivered spirometry quality improvement program in people with Asthma, run by Seattle Children's Hospital at 4 sites 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 5 inclusion and 5 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Healthcare utilization (time frame: Assessed monthly for 1 year). The study lists 3 primary outcomes in all. 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 20 May 2015.