CHICA Developmental Screening Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Aaron Carroll, Indiana University
ClinicalTrials.gov Identifier:
NCT01351077
First received: May 9, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Developmental Delay
Other: CHICA DevScreen Module

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research

Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Percent of children screened for Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Age of children diagnosed with Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent of children with a positive screen [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of children referred for evaluation and services when there was a positive screening result [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of referred evaluations and services that were completed [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of children diagnosed with developmental delay [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of parents assessed for developmental concerns [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Percent of visits with PCP noted assessment of developmental concerns [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHICA DevScreen Module
This arm will get the CHICA Developmental Screening Module
Other: CHICA DevScreen Module
This module assists in the diagnosis and management of developmental screening
No Intervention: CHICA DevScreen Control
This arm will get CHICA without the developmental screening module

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351077

Locations
United States, Indiana
Children's Health Services Research
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
Principal Investigator: Aaron E Carroll, MD, MS Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Aaron Carroll, Assoc. Prof of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT01351077     History of Changes
Other Study ID Numbers: CHICA_DevScreen_Study, R01HS017939
Study First Received: May 9, 2011
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Developmental Delay

ClinicalTrials.gov processed this record on August 20, 2014