The CHICA Developmental Screening Study

NCT ID: NCT01351077

Last Updated: 2017-06-26

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Developmental Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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CHICA DevScreen Module

This arm will get the CHICA Developmental Screening Module

Group Type EXPERIMENTAL

CHICA DevScreen Module

Intervention Type OTHER

This module assists in the diagnosis and management of developmental screening

CHICA DevScreen Control

This arm will get CHICA without the developmental screening module

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CHICA DevScreen Module

This module assists in the diagnosis and management of developmental screening

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Aaron Carroll

Assoc. Prof of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aaron E Carroll, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Children's Health Services Research

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for developmental surveillance and screening: a randomized clinical trial. JAMA Pediatr. 2014 Sep;168(9):815-21. doi: 10.1001/jamapediatrics.2014.464.

Reference Type DERIVED
PMID: 25022724 (View on PubMed)

Other Identifiers

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R01HS017939

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

CHICA_DevScreen_Study

Identifier Type: -

Identifier Source: org_study_id

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