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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS017939 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHICA DevScreen Module | Experimental | This arm will get the CHICA Developmental Screening Module |
|
| CHICA DevScreen Control | No Intervention | This arm will get CHICA without the developmental screening module |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHICA DevScreen Module | Other | This module assists in the diagnosis and management of developmental screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Children Screened for Developmental Delay | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Age of Children Diagnosed With Developmental Delay | one year |
| Measure | Description | 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 |
Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Aaron E Carroll, MD, MS | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Health Services Research | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25022724 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | CHICA DevScreen Control | This arm will get CHICA without the developmental screening module |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | CHICA DevScreen Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Children Screened for Developmental Delay | Posted | Count of Participants | Participants | one year |
|
|
two years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aaron E. Carroll, MD, MS | Indiana University School of Medicine | 3172789616 | aaecarro@iu.edu |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| one year |
This arm will get CHICA without the developmental screening module
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Insurance | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Age of Children Diagnosed With Developmental Delay | The denominator was only children diagnosed with developmental delay | Posted | Mean | Standard Deviation | months | one year |
|
|
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| Other Pre-specified | Number of Children With a Positive Screen | The denominator was number of children for whom a standard developmental screening tool was administered | Posted | Count of Participants | Participants | one year |
|
|
|
| Other Pre-specified | Number of Children Referred for Evaluation and Services When There Was a Positive Screening Result | The denominator was the number of children with a positive screen | Posted | Count of Participants | Participants | one year |
|
|
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| Other Pre-specified | Number of Patients Whose Referred Evaluations and Services Were Completed | Posted | Count of Participants | Participants | one year |
|
|
|
| 0 |
| 180 |
| 0 |
| 180 |
| EG001 | CHICA DevScreen Control | This arm will get CHICA without the developmental screening module | 0 | 180 | 0 | 180 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |