search
Back to results

Improving Asthma Outcomes Through Spirometry Distance Learning

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spirometry 360 program - Virtually-delivered spirometry quality improvement program
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance

Eligibility Criteria

5 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Slone Center Office-based Research Network (SCOR) - Boston University
  • Seattle Children's Hospital Research Institute
  • Child Health Institute - Unversity of Washington
  • Puget Sound Pediatric Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard of Care

Arm Description

Virtually-delivered spirometry quality improvement program

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Acceptable spirometry testing sessions
Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
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.

Full Information

First Posted
July 20, 2010
Last Updated
May 18, 2015
Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, Boston University
search

1. Study Identification

Unique Protocol Identification Number
NCT01168635
Brief Title
Improving Asthma Outcomes Through Spirometry Distance Learning
Official Title
Improving Asthma Outcomes Through Spirometry Distance Learning
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
University of Washington, Boston University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Spirometry, Pediatric, Primary Health Care, Education, Distance

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Virtually-delivered spirometry quality improvement program
Arm Title
Standard of Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Spirometry 360 program - Virtually-delivered spirometry quality improvement program
Intervention 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.
Primary Outcome Measure Information:
Title
Healthcare utilization
Description
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.
Time Frame
Assessed monthly for 1 year
Title
Cost of asthma care
Description
Cost in inflation-adjusted dollars for unplanned healthcare utilization due to asthma exacerbation, including unplanned office visits, ED visits, and asthma-related hospitalization.
Time Frame
Every 6 months
Title
Asthma-specific health-related quality of life
Description
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.
Time Frame
Every 6 months
Secondary Outcome Measure Information:
Title
Acceptable spirometry testing sessions
Description
Monthly proportion of spirometry tests performed by enrolled practices with acceptable quality grades during intervention.
Time Frame
Assessed monthly for 1 year
Title
Appropriate prescription of controller therapy
Description
Parent/child report asthma symptoms and unplanned health care utilization consistent with persistent/uncontrolled asthma AND patient has been prescribed a controller medication.
Time Frame
Assessed monthly for 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Mangione-Smith, MD, MPH
Organizational Affiliation
Seattle Children's Hospital/University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Slone Center Office-based Research Network (SCOR) - Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Seattle Children's Hospital Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Child Health Institute - Unversity of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Puget Sound Pediatric Research Network
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.spirometrytraining.org/
Description
Site for primary care physicians to learn about Spirometry

Learn more about this trial

Improving Asthma Outcomes Through Spirometry Distance Learning

We'll reach out to this number within 24 hrs