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Better Pediatric Asthma Outcomes Through Chronic Care

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electronic (computer based) provider feedback tool
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring pediatric, asthma, translational research, health information technology

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: determined by provider to be asthmatic member of Medical Managed Care Organization partner group Exclusion Criteria: -

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education

Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education

Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt

Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education)

Outcomes

Primary Outcome Measures

asthma control
guideline appropriate medicating by providers
patient knowledge

Secondary Outcome Measures

self efficacy
social support

Full Information

First Posted
July 19, 2006
Last Updated
May 27, 2014
Sponsor
UConn Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT00355069
Brief Title
Better Pediatric Asthma Outcomes Through Chronic Care
Official Title
Better Pediatric Asthma Outcomes Through Chronic Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology; 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatric, asthma, translational research, health information technology

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education
Arm Title
2
Arm Type
Experimental
Arm Description
Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education
Arm Title
3
Arm Type
Experimental
Arm Description
Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education)
Intervention Type
Behavioral
Intervention Name(s)
electronic (computer based) provider feedback tool
Other Intervention Name(s)
UCAN Control Asthma Program, Medication Assessment Prompt (MAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
asthma control
Time Frame
assessed at all 5 study visits
Title
guideline appropriate medicating by providers
Time Frame
assessed at all 5 study visits
Title
patient knowledge
Time Frame
assessed at all 5 study visits
Secondary Outcome Measure Information:
Title
self efficacy
Time Frame
assessed at all 5 study visits
Title
social support
Time Frame
assessed at all 5 study visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: determined by provider to be asthmatic member of Medical Managed Care Organization partner group Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Fifield, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15669584
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. doi: 10.1089/dis.2004.7.244.
Results Reference
background
PubMed Identifier
12393083
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. doi: 10.1016/s0895-4356(02)00428-6.
Results Reference
background
PubMed Identifier
20812783
Citation
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 redesign support to deliver a chronic care model. J Asthma. 2010 Sep;47(7):718-27. doi: 10.3109/02770903.2010.486846.
Results Reference
result

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Better Pediatric Asthma Outcomes Through Chronic Care

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