NCT01161433

Brief Summary

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society. The goal of this study is to evaluate the effectiveness of a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2007

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

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

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 15, 2010

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

11 months

First QC Date

June 15, 2010

Last Update Submit

July 9, 2010

Conditions

Keywords

AsthmaSpirometryPediatricPrimary Health CareEducation, Distance

Outcome Measures

Primary Outcomes (1)

  • Spirometry test quality

    Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society.

    Seven months

Secondary Outcomes (4)

  • Presence of asthma care plan

    Seven months

  • Asthma severity documentation

    Seven months

  • Appropriate prescription of controller therapy

    Seven months

  • Frequency of office-based spirometry

    Seven months

Study Arms (2)

Intervention

EXPERIMENTAL

Virtually delivered spirometry quality improvement program

Behavioral: Virtually delivered spirometry quality improvement program

Standard of Care

NO INTERVENTION

Interventions

Sites in the intervention arm receive the virtually delivered QI program. The program includes: 1. Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data; 2. Case-based, interactive webinars; and 3. an Internet-based spirometry quality feedback reporting system.

Intervention

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Internet access on a computer running Windows XP SP2
  • Access to a computer with Windows 2000 /Mac OS 10 or higher
  • Practices must match another enrolled practice on the following parameters.
  • Number of providers in practice (same number +/- 1 provider)
  • Location - both practices must either be urban or rural
  • % of patients eligible for Medicaid (same percentage +/- 15%)
  • Practice type (school-based clinic, Federally Qualified Health Center, private practice, hospital- or university-based clinic)
  • Geographic distance (minimum of 10 miles away from matched pair practice)

You may not qualify if:

  • Lack of Internet access on a computer running Windows XP SP2
  • Lack of access to a computer with Windows 2000 /Mac OS 10 or higher
  • Practices that were unable to be matched to another similar practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

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

  • James W Stout, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR
  • Rita Mangione-Smith, MD, MPH

    University of Washington/Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2010

First Posted

July 13, 2010

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 13, 2010

Record last verified: 2010-07

Locations