NCT01168635

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

July 20, 2010

Last Update Submit

May 18, 2015

Conditions

Keywords

AsthmaSpirometryPediatricPrimary Health CareEducation, Distance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Every 6 months

Secondary Outcomes (2)

  • Acceptable spirometry testing sessions

    Assessed monthly for 1 year

  • Appropriate prescription of controller therapy

    Assessed monthly for 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Virtually-delivered spirometry quality improvement program

Behavioral: Spirometry 360 program - Virtually-delivered spirometry quality improvement program

Standard of Care

NO INTERVENTION

Interventions

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.

Intervention

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Slone Center Office-based Research Network (SCOR) - Boston University

Boston, Massachusetts, 02215, United States

Location

Seattle Children's Hospital Research Institute

Seattle, Washington, 98101, United States

Location

Child Health Institute - Unversity of Washington

Seattle, Washington, 98195, United States

Location

Puget Sound Pediatric Research Network

Seattle, Washington, 98195, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Rita Mangione-Smith, MD, MPH

    Seattle Children's Hospital/University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2010

First Posted

July 23, 2010

Study Start

June 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations