Improving Asthma Outcomes Through Spirometry Distance Learning

Asthma Clinical Trial

Official title:

Improving Asthma Outcomes Through Spirometry Distance Learning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168635
• Other study ID #: 13169
• Status: Completed
• Phase: N/A
• First received: July 20, 2010
• Last updated: May 18, 2015
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Slone Center Office-based Research Network (SCOR) - Boston University	Boston	Massachusetts
United States	Child Health Institute - Unversity of Washington	Seattle	Washington
United States	Puget Sound Pediatric Research Network	Seattle	Washington
United States	Seattle Children's Hospital Research Institute	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Boston University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Acceptable spirometry testing sessions	Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.	Assessed monthly for 1 year	No
Secondary	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.	Assessed monthly for 1 year	No

External Links

•   Spirometry Fundamentals™ Licensing Website