An interventional study of CHICA DevScreen Module in Developmental Delay, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 1 Day to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-26.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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
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
150 studies on the registry are indexed under Learning Disabilities; 51 are open to participants now.
This study's enrollment of 360 is above the median of 60 across 101 interventional studies indexed under Learning Disabilities.
Browse Learning Disabilities studies →Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
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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:
This arm will get the CHICA Developmental Screening Module
Other: CHICA DevScreen Module
This arm will get CHICA without the developmental screening module
This module assists in the diagnosis and management of developmental screening
Number of Children Screened for Developmental Delay
Time frame: one year
Age of Children Diagnosed With Developmental Delay
Time frame: one year
Number of Children With a Positive Screen
Time frame: one year
Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result
Time frame: one year
Number of Patients Whose Referred Evaluations and Services Were Completed
Time frame: one year
| Milestone | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Started | 180 | 180 |
| Completed | 180 | 180 |
| Not completed | 0 | 0 |
| Participants | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Number of Children Screened for Developmental Delay | 153 | 44 |
| months | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Age of Children Diagnosed With Developmental Delay | 19.8 ± 5.1 | 23.8 ± 6.5 |
| Participants | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Number of Children With a Positive Screen | 30 | 8 |
| Participants | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result | 22 | 4 |
| Participants | CHICA DevScreen Module | CHICA DevScreen Control |
|---|---|---|
| Number of Patients Whose Referred Evaluations and Services Were Completed | 12 | 1 |
Collected over two years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CHICA DevScreen Module | — | 0/180 (0%) | 0/180 (0%) |
| CHICA DevScreen Control | — | 0/180 (0%) | 0/180 (0%) |
| Age, Continuous(months) | CHICA DevScreen Module | CHICA DevScreen Control | Total |
|---|---|---|---|
| Mean | 19.8 ± 5.1 | 23.7 ± 6.5 | 21.8 ± 5.8 |
| Sex: Female, Male(Participants) | CHICA DevScreen Module | CHICA DevScreen Control | Total |
|---|---|---|---|
| Female | 97 | 91 | 188 |
| Male | 83 | 89 | 172 |
| Race/Ethnicity, Customized(Participants) | CHICA DevScreen Module | CHICA DevScreen Control | Total |
|---|---|---|---|
| Black | 51 | 164 | 215 |
| Hispanic | 117 | 11 | 128 |
| White/Asian | 11 | 4 | 15 |
| Other | 1 | 1 | 2 |
| Insurance(Participants) | CHICA DevScreen Module | CHICA DevScreen Control | Total |
|---|---|---|---|
| Advantage/Commercial | 8 | 6 | 14 |
| Self-pay | 12 | 2 | 14 |
| Medicaid | 160 | 171 | 331 |
Plan to share: No
The record gives a start of May 2011, a primary completion of Dec 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 4 years 6 months after primary completion.
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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