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A Multifaceted Prompting Intervention for Urban Children With Asthma (PAIR-UP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01105754
First Posted: April 16, 2010
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
  Purpose
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.

Condition Intervention
Asthma Behavioral: Multifaceted Prompting Intervention MPI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Multifaceted Prompting Intervention for Urban Children With Asthma

Further study details as provided by Jill Halterman, University of Rochester:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 638
Study Start Date: October 2008
Study Completion Date: December 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Multifaceted Prompting 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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105754


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
  More Information

Publications:
Responsible Party: Jill Halterman, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01105754     History of Changes
Other Study ID Numbers: 25281
1R01HL091835-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2010
First Posted: April 16, 2010
Results First Submitted: September 15, 2015
Results First Posted: October 16, 2015
Last Update Posted: February 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases