Developmental Delay
Conditions
Keywords
Developmental Delay
Brief summary
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
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
Interventions
OTHERCHICA DevScreen Module
This module assists in the diagnosis and management of developmental screening
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Children Screened for Developmental Delay | one year |
Secondary
| Measure | Time frame |
|---|---|
| Age of Children Diagnosed With Developmental Delay | one year |
Other
| Measure | Time frame |
|---|---|
| Number of Children With a Positive Screen | one year |
| Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result | one year |
| Number of Patients Whose Referred Evaluations and Services Were Completed | one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CHICA DevScreen Module This arm will get the CHICA Developmental Screening Module
CHICA DevScreen Module: This module assists in the diagnosis and management of developmental screening | 180 |
| CHICA DevScreen Control This arm will get CHICA without the developmental screening module | 180 |
| Total | 360 |
Baseline characteristics
| Characteristic | CHICA DevScreen Control | Total | CHICA DevScreen Module |
|---|---|---|---|
| Age, Continuous | 23.7 months STANDARD_DEVIATION 6.5 | 21.8 months STANDARD_DEVIATION 5.8 | 19.8 months STANDARD_DEVIATION 5.1 |
| Insurance Advantage/Commercial | 6 Participants | 14 Participants | 8 Participants |
| Insurance Medicaid | 171 Participants | 331 Participants | 160 Participants |
| Insurance Self-pay | 2 Participants | 14 Participants | 12 Participants |
| Race/Ethnicity, Customized Black | 164 Participants | 215 Participants | 51 Participants |
| Race/Ethnicity, Customized Hispanic | 11 Participants | 128 Participants | 117 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Asian | 4 Participants | 15 Participants | 11 Participants |
| Sex: Female, Male Female | 91 Participants | 188 Participants | 97 Participants |
| Sex: Female, Male Male | 89 Participants | 172 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 180 | 0 / 180 |
| serious Total, serious adverse events | 0 / 180 | 0 / 180 |
Outcome results
Primary
Number of Children Screened for Developmental Delay
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHICA DevScreen Module | Number of Children Screened for Developmental Delay | 153 Participants |
| CHICA DevScreen Control | Number of Children Screened for Developmental Delay | 44 Participants |
Secondary
Age of Children Diagnosed With Developmental Delay
Time frame: one year
Population: The denominator was only children diagnosed with developmental delay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CHICA DevScreen Module | Age of Children Diagnosed With Developmental Delay | 19.8 months | Standard Deviation 5.1 |
| CHICA DevScreen Control | Age of Children Diagnosed With Developmental Delay | 23.8 months | Standard Deviation 6.5 |
Other Pre-specified
Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result
Time frame: one year
Population: The denominator was the number of children with a positive screen
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHICA DevScreen Module | Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result | 22 Participants |
| CHICA DevScreen Control | Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result | 4 Participants |
Other Pre-specified
Number of Children With a Positive Screen
Time frame: one year
Population: The denominator was number of children for whom a standard developmental screening tool was administered
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHICA DevScreen Module | Number of Children With a Positive Screen | 30 Participants |
| CHICA DevScreen Control | Number of Children With a Positive Screen | 8 Participants |
Other Pre-specified
Number of Patients Whose Referred Evaluations and Services Were Completed
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CHICA DevScreen Module | Number of Patients Whose Referred Evaluations and Services Were Completed | 12 Participants |
| CHICA DevScreen Control | Number of Patients Whose Referred Evaluations and Services Were Completed | 1 Participants |