Better Pediatric Asthma Outcomes Through Chronic Care

Asthma Clinical Trial

Official title:

Better Pediatric Asthma Outcomes Through Chronic Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355069
• Other study ID #: 1U18HS011068-01
• Secondary ID: U18HS011068
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: May 27, 2014
• Start date: August 2001
• Est. completion date: May 2003

Study information

• Verified date: May 2014
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 548
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

Inclusion Criteria:

• determined by provider to be asthmatic

• member of Medical Managed Care Organization partner group

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
University of Connecticut Health Center	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fifield J, McQuillan J, Martin-Peele M, Nazarov V, Apter AJ, Babor T, Burleson J, Cushman R, Hepworth J, Jackson E, Reisine S, Sheehan J, Twiggs J. Improving pediatric asthma control among minority children participating in medicaid: providing practice re — View Citation

Twiggs JE, Fifield J, Apter AJ, Jackson EA, Cushman RA. Stratifying medical and pharmaceutical administrative claims as a method to identify pediatric asthma patients in a Medicaid managed care organization. J Clin Epidemiol. 2002 Sep;55(9):938-44. — View Citation

Twiggs JE, Fifield J, Jackson E, Cushman R, Apter A. Treating asthma by the guidelines: developing a medication management information system for use in primary care. Dis Manag. 2004 Fall;7(3):244-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	asthma control		assessed at all 5 study visits	No
Primary	guideline appropriate medicating by providers		assessed at all 5 study visits	No
Primary	patient knowledge		assessed at all 5 study visits	No
Secondary	self efficacy		assessed at all 5 study visits	No
Secondary	social support		assessed at all 5 study visits	No