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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01105754
First received: April 15, 2010
Last updated: July 25, 2014
Last verified: July 2014
  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 Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Multifaceted Prompting Intervention for Urban Children With Asthma

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Symptom Free Days [ Time Frame: 2 month follow-up assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 638
Study Start Date: October 2008
Estimated Primary Completion Date: July 2015 (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: 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

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105754

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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
Study First Received: April 15, 2010
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014