Better Pediatric Asthma Outcomes Through Chronic Care

May 27, 2014 updated by: Judith Fifield, UConn Health

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

548

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
asthma control
Time Frame: assessed at all 5 study visits
assessed at all 5 study visits
guideline appropriate medicating by providers
Time Frame: assessed at all 5 study visits
assessed at all 5 study visits
patient knowledge
Time Frame: assessed at all 5 study visits
assessed at all 5 study visits

Secondary Outcome Measures

Outcome Measure
Time Frame
self efficacy
Time Frame: assessed at all 5 study visits
assessed at all 5 study visits
social support
Time Frame: assessed at all 5 study visits
assessed at all 5 study visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

May 1, 2003

Study Completion (ACTUAL)

May 1, 2003

Study Registration Dates

First Submitted

July 19, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (ESTIMATE)

July 21, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1U18HS011068-01 (AHRQ)
  • U18HS011068 (AHRQ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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