CHICA Developmental Screening Study
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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 |
- Number of children screened for Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]
- Number of children diagnosed with Developmental Delay [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (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 |
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| Contact: Aaron E Carroll, MD, MS | 3172780552 | aaecarro@iupui.edu |
| United States, Indiana | |
| Children's Health Services Research | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| 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: | November 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
Developmental Delay |
ClinicalTrials.gov processed this record on May 16, 2013