Improving Asthma Outcomes Through Spirometry Distance Learning

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Washington
Boston University
Information provided by (Responsible Party):
Rita Mangione-Smith, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01168635
First received: July 20, 2010
Last updated: May 19, 2014
Last verified: May 2014

July 20, 2010
May 19, 2014
June 2010
January 2012   (final data collection date for primary outcome measure)
  • Healthcare utilization [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • Healthcare utilization [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]
    Parent report of number of 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Parent report of child's asthma-specific health-related quality of life. Measured using PedsQL(TM) 3.0 SF-22 Asthma Module. The tool consists of an 11-item symptoms scale and an 11-item treatment problems scale.
Complete list of historical versions of study NCT01168635 on ClinicalTrials.gov Archive Site
  • Acceptable spirometry testing sessions [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]
    Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
  • Appropriate prescription of controller therapy [ Time Frame: Assessed monthly for 1 year ] [ Designated as safety issue: No ]
    Parent/child report asthma symptoms and unplanned health care utilization consistent with persistent/uncontrolled asthma AND patient has been prescribed a controller medication.
Same as current
Not Provided
Not Provided
 
Improving Asthma Outcomes Through Spirometry Distance Learning
Improving Asthma Outcomes Through Spirometry Distance Learning

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.

The 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Asthma
Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program

The 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.
  • Experimental: Intervention
    Virtually-delivered spirometry quality improvement program
    Intervention: Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program
  • No Intervention: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1500
December 2014
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria (Parent):

  • 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

Inclusion Criteria (Child):

  • Aged 5-16 years
  • Must have access to email and the Internet

Exclusion Criteria (Parents):

  • 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

Exclusion Criteria (Child):

  • Children who are outside our target age range of 5-16 years
  • Children without monthly access to email and the Internet
Both
5 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01168635
13169
Yes
Rita Mangione-Smith, Seattle Children's Hospital
Seattle Children's Hospital
  • University of Washington
  • Boston University
Principal Investigator: Rita Mangione-Smith, MD, MPH Seattle Children's Hospital/University of Washington
Seattle Children's Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP