NCT00156468

Brief Summary

In prior work, we found that even children who have been seen by their physicians within the prior six months were frequently misclassified as having mild rather than persistent asthma. This study evaluations whether systematic office-based screening assists primary care physicians in identifying children with significant asthma and improves preventive care for asthma. We hypothesize that standardized screening in the office setting will improve the physician's ability to (a) identify children with significant asthma and (b) prescribe appropriate preventive medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Oct 2003

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, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

First QC Date

September 8, 2005

Last Update Submit

May 11, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • "Preventive Medication Actions (PMA)" taken by the provider at the time of the child's visit. A "PMA" is defined as a new medication prescription or change in medication dose.

Secondary Outcomes (1)

  • Alternate actions taken by the provider such as: discussion of environmental controls, medication refills, etc.

Interventions

Provider PromptBEHAVIORAL

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 2-12
  • Children arriving for an office visit in two Rochester, NY pediatric clinics
  • Children with a prior diagnosis of asthma AND an exacerbation of symptoms within the previous 2 years

You may not qualify if:

  • Children arriving at the office visit with an adult that is not their parent or guardian
  • Children arriving at the office visit with a parent or guardian that does not speak English
  • Children with other medical conditions making the assessment of asthma severity difficult (cystic fibrosis, heart conditions, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (3)

  • Halterman JS, Kitzman H, McMullen A, Lynch K, Fagnano M, Conn KM, Yoos HL. Quantifying preventive asthma care delivered at office visits: the Preventive Asthma Care-Composite Index (PAC-CI). J Asthma. 2006 Sep;43(7):559-64. doi: 10.1080/02770900600859172.

    PMID: 16939999BACKGROUND
  • Halterman JS, Fagnano M, Conn KM, Szilagyi PG. Do parents of urban children with persistent asthma ban smoking in their homes and cars? Ambul Pediatr. 2006 Mar-Apr;6(2):115-9. doi: 10.1016/j.ambp.2005.10.004.

    PMID: 16530150BACKGROUND
  • Halterman JS, Fisher S, Conn KM, Fagnano M, Lynch K, Marky A, Szilagyi PG. Improved preventive care for asthma: a randomized trial of clinician prompting in pediatric offices. Arch Pediatr Adolesc Med. 2006 Oct;160(10):1018-25. doi: 10.1001/archpedi.160.10.1018.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Jill S Halterman, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

October 1, 2003

Study Completion

September 1, 2005

Last Updated

May 12, 2011

Record last verified: 2011-05

Locations