CHICA Developmental Screening Study

Developmental Delay Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351077
• Other study ID #: CHICA_DevScreen_Study
• Secondary ID: R01HS017939
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: February 6, 2014
• Start date: May 2011
• Est. completion date: December 2012

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Developmental Delay

Intervention

Other:
• CHICA DevScreen Module
This module assists in the diagnosis and management of developmental screening

Locations

Country	Name	City	State
United States	Children's Health Services Research	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of children with a positive screen		one year	No
Other	Percent of children referred for evaluation and services when there was a positive screening result		one year	No
Other	Percent of referred evaluations and services that were completed		one year	No
Other	Percent of children diagnosed with developmental delay		one year	No
Other	Percent of parents assessed for developmental concerns		one year	No
Other	Percent of visits with PCP noted assessment of developmental concerns		one year	No
Primary	Percent of children screened for Developmental Delay		one year	No
Secondary	Age of children diagnosed with Developmental Delay		one year	No