- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105754
A Multifaceted Prompting Intervention for Urban Children With Asthma (PAIR-UP)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Physician-diagnosed asthma
- Mild persistent or more severe asthma severity, or poor asthma control
- Age >2 and <12 years.
- Parent or caregiver must give permission to the study, and children >7 will must provide assent.
Exclusion Criteria:
- Inability to speak and understand English or Spanish
- No access to a working phone for follow-up surveys
- The child having other significant medical conditions,
- Children in foster care or other situations in which consent cannot be obtained from a guardian.
- Prior enrollment in the study.
- Child will not be seen by a physician or nurse practitioner during their visit
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider.
After the baseline assessment, the office visit will proceed according to usual care.
|
|
Experimental: Multifaceted Prompting Intervention
|
Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures. Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptom Free Days
Time Frame: 2 month follow-up assessment
|
The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.
|
2 month follow-up assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.
Time Frame: 2 week follow-up, and medical record review
|
The number of children who received guideline-based asthma care (eg: inhaled steroid prescription, counseling for triggers, counseling for adherence) at the intervention visit based on parent interview at the 2-week follow-up and medical record review.
|
2 week follow-up, and medical record review
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill S. Halterman, MD, MPH, University of Rochester
Publications and helpful links
General Publications
- Fagnano M, Berkman E, Wiesenthal E, Butz A, Halterman JS. Depression among caregivers of children with asthma and its impact on communication with health care providers. Public Health. 2012 Dec;126(12):1051-7. doi: 10.1016/j.puhe.2012.08.007. Epub 2012 Oct 25.
- Yee AB, Fagnano M, Halterman JS. Preventive asthma care delivery in the primary care office: missed opportunities for children with persistent asthma symptoms. Acad Pediatr. 2013 Mar-Apr;13(2):98-104. doi: 10.1016/j.acap.2012.10.009. Epub 2013 Jan 5.
- Gutierrez SJ, Fagnano M, Wiesenthal E, Koehler AD, Halterman JS. Discrepancies between medical record data and parent reported use of preventive asthma medications. J Asthma. 2014 May;51(4):446-50. doi: 10.3109/02770903.2013.878351. Epub 2014 Jan 30.
- Lewis P, Fagnano M, Koehler A, Halterman JS. Racial disparities at the point of care for urban children with persistent asthma. J Community Health. 2014 Aug;39(4):706-11. doi: 10.1007/s10900-013-9815-5.
- Carlin C, Yee AB, Fagnano M, Halterman JS. The influence of Hispanic ethnicity on parent-provider communication about asthma. Clin Pediatr (Phila). 2014 Apr;53(4):380-6. doi: 10.1177/0009922813510598. Epub 2013 Nov 26.
- Halterman JS, Fagnano M, Tremblay PJ, Fisher SG, Wang H, Rand C, Szilagyi P, Butz A. Prompting asthma intervention in Rochester-uniting parents and providers (PAIR-UP): a randomized trial. JAMA Pediatr. 2014 Oct;168(10):e141983. doi: 10.1001/jamapediatrics.2014.1983. Epub 2014 Oct 6.
- Goldstein NPN, Frey SM, Fagnano M, Okelo SO, Halterman JS. Identifying Which Urban Children With Asthma Benefit Most From Clinician Prompting: Subgroup Analyses From the Prompting Asthma Intervention in Rochester-Uniting Parents and Providers (PAIR-UP) Trial. Acad Pediatr. 2018 Apr;18(3):305-309. doi: 10.1016/j.acap.2017.08.015. Epub 2017 Sep 9.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25281
- 1R01HL091835-01A1 (U.S. NIH Grant/Contract)
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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