A Multifaceted Prompting Intervention for Urban Children With Asthma

Asthma Clinical Trial

— PAIR-UP  

Official title:

A Multifaceted Prompting Intervention for Urban Children With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105754
• Other study ID #: 25281
• Secondary ID: 1R01HL091835-01A
• Status: Completed
• Phase: N/A
• First received: April 15, 2010
• Last updated: January 15, 2016
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: December 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Multifaceted Prompting Intervention MPI
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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

Gutiérrez 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. — View Citation

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/jamapediatric — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom Free Days	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	No
Secondary	Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.	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	No