Better Pediatric Asthma Outcomes Through Chronic Care

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Judith Fifield, University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00355069
First received: July 19, 2006
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children.

The specific aims are to:

  1. Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;
  2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and
  3. Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.

The key product of the computer support system is a guideline prompt that serves as the mechanism for integrating patient specific data with standards of care. 548 children, ages 5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in CT, and receiving care at one of four Federally Qualified Community Health Centers will be recruited. All sites will have access to the computer support system and the to-be-developed, Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of prompts delivered at the point of care on patient outcomes will be compared to the effect of no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education will be assessed in combination with prompted care compared to no-prompt care and compared to no education. All patients will receive standard screening and outreach to keep appointments. Data will be obtained from medical records, medical and pharmacy claims data as well as patient and parent interviews at baseline and quarterly for 18 months.


Condition Intervention
Asthma
Behavioral: electronic (computer based) provider feedback tool

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Better Pediatric Asthma Outcomes Through Chronic Care

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • asthma control [ Time Frame: assessed at all 5 study visits ] [ Designated as safety issue: No ]
  • guideline appropriate medicating by providers [ Time Frame: assessed at all 5 study visits ] [ Designated as safety issue: No ]
  • patient knowledge [ Time Frame: assessed at all 5 study visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • self efficacy [ Time Frame: assessed at all 5 study visits ] [ Designated as safety issue: No ]
  • social support [ Time Frame: assessed at all 5 study visits ] [ Designated as safety issue: No ]

Enrollment: 548
Study Start Date: August 2001
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education
Behavioral: electronic (computer based) provider feedback tool
All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
Other Names:
  • UCAN Control Asthma Program
  • Medication Assessment Prompt (MAP)
Experimental: 2
Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education
Behavioral: electronic (computer based) provider feedback tool
All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
Other Names:
  • UCAN Control Asthma Program
  • Medication Assessment Prompt (MAP)
Experimental: 3
Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt
Behavioral: electronic (computer based) provider feedback tool
All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
Other Names:
  • UCAN Control Asthma Program
  • Medication Assessment Prompt (MAP)
Placebo Comparator: 4
Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education)
Behavioral: electronic (computer based) provider feedback tool
All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
Other Names:
  • UCAN Control Asthma Program
  • Medication Assessment Prompt (MAP)

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • determined by provider to be asthmatic
  • member of Medical Managed Care Organization partner group

Exclusion Criteria:

-

  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: NCT00355069

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
University of Connecticut Health Center
Investigators
Principal Investigator: Judith Fifield, PhD University of Connecticut Health Center
  More Information

Publications:
Responsible Party: Judith Fifield, Professor & Director, Ethel Donaghue TRIPP Center, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00355069     History of Changes
Other Study ID Numbers: 1U18HS11068-01, U18HS011068
Study First Received: July 19, 2006
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
pediatric
asthma
translational research
health information technology

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

ClinicalTrials.gov processed this record on August 28, 2014