Official Title: “Better Pediatric Asthma Outcomes Through Chronic Care”

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.

Study Type: Interventional

Study Design: Health Services Research, Non-Randomized, Single Blind (Subject), Factorial Assignment, Efficacy Study

Study Primary Completion Date: May 2003

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education
• Experimental: 2
  • Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education
• Experimental: 3
  • Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt
• Placebo Comparator: 4
  • Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education)

Primary Measures

• asthma control
  • Time Frame: assessed at all 5 study visits
    Safety Issue?: No
• guideline appropriate medicating by providers
  • Time Frame: assessed at all 5 study visits
    Safety Issue?: No
• patient knowledge
  • Time Frame: assessed at all 5 study visits
    Safety Issue?: No

Secondary Measures

• self efficacy
  • Time Frame: assessed at all 5 study visits
    Safety Issue?: No
• social support
  • Time Frame: assessed at all 5 study visits
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

-

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Connecticut Health Center

Overall Clinical Trial Officials and Contacts

Judith Fifield, PhD Principal Investigator University of Connecticut Health Center  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00355069

Study ID Number: 1U18HS11068-01

ClinicalTrials.gov Identifier: NCT00355069

Health Authority: United States: Institutional Review Board