CHICA Developmental Screening Study

This study is currently recruiting participants.
Verified November 2012 by Indiana University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier:
NCT01351077
First received: May 9, 2011
Last updated: November 13, 2012
Last verified: November 2012

May 9, 2011
November 13, 2012
October 2010
July 2013   (final data collection date for primary outcome measure)
Number of children screened for Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01351077 on ClinicalTrials.gov Archive Site
Number of children diagnosed with Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
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CHICA Developmental Screening Study
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Between 12 and 16% of children in the United States have a developmental disability. Research has demonstrated that early intervention programs are not only essential for improved outcomes in these children, but also cost-effective. As a result, there has been a push within the pediatric medical community to identify children with developmental delays or disabilities as early as possible. Currently, most pediatric primary care providers do not use standardized methods for developmental surveillance and screening. Instead they rely on intuition and clinical judgment which has been shown to have limitations when compared with standardized screening methods. Researchers and physician organizations such as the AAP have called on pediatric primary care providers to institute a standardized approach for the identification of developmental delays that includes both developmental surveillance and screening. In fact, the AAP recently published an algorithm for developmental surveillance and screening within a primary care setting. Physicians, however, cite several barriers to the implementation of these recommendations within their practices, including lack of time, lack of office staff, inadequate reimbursement, and language barriers.

The investigators have developed a novel computer decision support system (CDSS) for implementing clinical guidelines and algorithms within pediatric practices called CHICA. The investigators believe that this CDSS has the potential to address the barriers cited in previous studies as obstacles specific to the implementation of developmental surveillance and screening within primary care practices. CDSS will allow for developmental surveillance and screening to fit within the workflow of a busy pediatric practice without requiring an additional investment of time on the part of the physician and without requiring additional office staff.

The aims of this study are to (1) Expand and modify an existing computer-based decision support system (CHICA) to include the 2006 AAP developmental surveillance and screening algorithm; (2) Evaluate the effect of the CHICA system on the developmental surveillance and screening practices of four pediatric clinics; (3) Evaluate the effect of the CHICA system on referrals for developmental and medical evaluations as well as early developmental intervention/early childhood services for those children identified as having concerning developmental screening results; and (4) Develop a cohort of children with identified developmental disabilities that can be followed over time in order to look at the end results/effects of developmental screening

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Developmental Delay
Other: CHICA DevScreen Module
This module assists in the diagnosis and management of developmental screening
  • Experimental: CHICA DevScreen Module
    This arm will get the CHICA Developmental Screening Module
    Intervention: Other: CHICA DevScreen Module
  • No Intervention: CHICA DevScreen Control
    This arm will get CHICA without the developmental screening module
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • This study will involve the analysis of data collected in the care of children seen in four IUMG-PC pediatric clinics. For aim 2 of the study all children between the ages of 0 and 3 seen in the four study clinics will be eligible for and will be participants in the study.

For aim 3 of the study, a child is eligible for participation if they are younger than 5 years of age, have a concerning developmental screening result, and are seen in one of the four clinics participating in this study. Additionally, these children cannot have a previous diagnosis of a developmental disorder and at least one of the child's parents must speak English.

Exclusion Criteria:

  • For aim 3, having no parents who can speak English
Both
up to 3 Years
Yes
Contact: Aaron E Carroll, MD, MS 3172780552 aaecarro@iupui.edu
United States
 
NCT01351077
CHICA_DevScreen_Study, R01HS017939
No
Aaron Carroll, Indiana University
Indiana University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Aaron E Carroll, MD, MS Indiana University School of Medicine
Indiana University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP