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: February 11, 2014
Last verified: June 2011
  Purpose

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.


Condition Intervention
Asthma
Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Asthma Outcomes Through Spirometry Distance Learning

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1500
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Virtually-delivered spirometry quality improvement program
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.
No Intervention: Standard of Care

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168635

Locations
United States, Massachusetts
Slone Center Office-based Research Network (SCOR) - Boston University
Boston, Massachusetts, United States, 02215
United States, Washington
Seattle Children's Hospital Research Institute
Seattle, Washington, United States, 98101
Puget Sound Pediatric Research Network
Seattle, Washington, United States, 98195
Child Health Institute - Unversity of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Seattle Children's Hospital
University of Washington
Boston University
Investigators
Principal Investigator: Rita Mangione-Smith, MD, MPH Seattle Children's Hospital/University of Washington
  More Information

Additional Information:
No publications provided

Responsible Party: Rita Mangione-Smith, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01168635     History of Changes
Other Study ID Numbers: 13169
Study First Received: July 20, 2010
Last Updated: February 11, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
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 April 23, 2014