- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00156468
Office-Based Asthma Screening Intervention
May 11, 2011 updated by: University of Rochester
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.
Study Overview
Study Type
Interventional
Enrollment
365
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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"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.
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Secondary Outcome Measures
Outcome Measure |
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Alternate actions taken by the provider such as: discussion of environmental controls, medication refills, etc.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jill S Halterman, MD, MPH, University of Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
September 1, 2005
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
May 12, 2011
Last Update Submitted That Met QC Criteria
May 11, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10035
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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