AsthmaNCT00156468
Office-Based Asthma Screening Intervention
A study testing Provider Prompt in people with Asthma, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Provider Prompt
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Asthma
- Being tested
- Provider Prompt
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider PromptBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 365 participants
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Halcyon Hill Foundation, Robert Wood Johnson Foundation
- Investigators
- Jill S Halterman, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156468
- Sponsor's protocol ID
- 10035
- Status last verified
- May 2011
- First submitted
- 8 Sep 2005
- Last updated
- 12 May 2011
- Results posted
- No
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.
PubMed 16939999Halterman 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.
PubMed 16530150Halterman 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.
PubMed 17018460
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Office-Based Asthma Screening Intervention
- ClinicalTrials.gov ID
- NCT00156468
- Acronym / sponsor ID
- 10035
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Halcyon Hill Foundation, Robert Wood Johnson Foundation
- Study start
- Oct 2003
- Study completion
- Sep 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider Prompt | Behavioural | – |
Primary outcome
"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.
1 secondary outcome
Alternate actions taken by the provider such as: discussion of environmental controls, medication refills, etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2011.
- Background: PubMed 16939999Halterman 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.
- Background: PubMed 16530150Halterman 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.
- Results publication: PubMed 17018460Halterman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill S Halterman, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider Prompt in people with Asthma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00156468, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011; AzTrials last refreshed its copy on 2 Nov 2026.