NCT00355069

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:

  1. 1.Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;
  2. 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. 3.Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

July 19, 2006

Last Update Submit

May 27, 2014

Conditions

Asthma

Keywords

pediatricasthmatranslational researchhealth information technology

Outcome Measures

Primary Outcomes (3)

  • asthma control

    assessed at all 5 study visits

  • guideline appropriate medicating by providers

    assessed at all 5 study visits

  • patient knowledge

    assessed at all 5 study visits

Secondary Outcomes (2)

  • self efficacy

    assessed at all 5 study visits

  • social support

    assessed at all 5 study visits

Study Arms (4)

1

EXPERIMENTAL

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

Behavioral: electronic (computer based) provider feedback tool

2

EXPERIMENTAL

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

Behavioral: electronic (computer based) provider feedback tool

3

EXPERIMENTAL

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

Behavioral: electronic (computer based) provider feedback tool

4

PLACEBO COMPARATOR

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

Behavioral: electronic (computer based) provider feedback tool

Interventions

electronic (computer based) provider feedback toolBEHAVIORAL

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.

Also known as: UCAN Control Asthma Program, Medication Assessment Prompt (MAP)
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Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Related Publications (3)

  • 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.

    PMID: 15669584BACKGROUND

  • 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.

    PMID: 12393083BACKGROUND

  • 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.

    PMID: 20812783RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Judith Fifield, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Director, Ethel Donaghue TRIPP Center

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 21, 2006

Study Start

August 1, 2001

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)