A Multifaceted Prompting Intervention for Urban Children With Asthma

NCT01105754 | Completed Results

• 2 other identifiers: 252811R01HL091835-01A1
• Study Type: interventional
• Target: 638
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.

  2 week follow-up, and medical record review

Study Arms (2)

Standard Care

NO INTERVENTION

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.

Multifaceted Prompting Intervention

EXPERIMENTAL

Multifaceted Prompting Intervention

Behavioral: Multifaceted Prompting Intervention MPI

Interventions

Multifaceted Prompting Intervention MPI BEHAVIORAL

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.

Multifaceted Prompting Intervention

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (7)

• 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.

  PMID: 23102501 BACKGROUND

• 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.

  PMID: 23294977 BACKGROUND

• 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.

  PMID: 24404799 BACKGROUND

• 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.

  PMID: 24435717 BACKGROUND

• 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.

  PMID: 24281159 BACKGROUND

• 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.

  PMID: 25288141 RESULT

• 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.

  PMID: 28899842 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Jill Halterman
• Organization: University of Rochester

jill_halterman@urmc.rochester.edu

585-275-5798

Study Officials

• Jill S. Halterman, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 16, 2010
• Study Start: October 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2015
• Last Updated: February 8, 2016
• Results First Posted: October 16, 2015

Record last verified: 2016-01

Locations

US (1)