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Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism (CAAC)

Primary Purpose

Healthy Children Undergoing Routine Care, Children With Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer based care reminders
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Healthy Children Undergoing Routine Care focused on measuring autism, well child care, screening, computer, reminders

Eligibility Criteria

17 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study.

Exclusion Criteria:

  • Previously known autism spectrum disorders or other causes of developmental delay

Sites / Locations

  • Wishard (Eskenazi) Healthcare clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computer based reminders to MD

Usual care arm

Arm Description

Children in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism.

Children in this are receive usual care from a clinic randomly chosen to serve as a control.

Outcomes

Primary Outcome Measures

Structure autism screening instrument administered
Physicians are reminded by the computer system to screen children under 3 years of age for autism with a structured screening instrument. Chart abstraction is used to document whether or not the screening occurred.

Secondary Outcome Measures

Are appropriate diagnostic studies conducted among children who screen positive for autism.
Among children who a suspected of having autism, chart abstraction and interviews are done to determine if the child received appropriate diagnostic and studies.

Full Information

First Posted
June 4, 2012
Last Updated
March 23, 2015
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT01612897
Brief Title
Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism
Acronym
CAAC
Official Title
Computer Assisted Autism Care (CAAC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesize that children seen in a clinic that uses a compute based system known as CHICA, which reminds pediatricians to screen at defined time point for autism, will be screened more consistently for autism and receive more timely diagnostic a treatment services.
Detailed Description
To be eligible for this trial, participants must receive their care at one of four primary care clinics in Indianapolis where the CHICA system is used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Children Undergoing Routine Care, Children With Autism
Keywords
autism, well child care, screening, computer, reminders

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computer based reminders to MD
Arm Type
Experimental
Arm Description
Children in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism.
Arm Title
Usual care arm
Arm Type
No Intervention
Arm Description
Children in this are receive usual care from a clinic randomly chosen to serve as a control.
Intervention Type
Other
Intervention Name(s)
Computer based care reminders
Intervention Description
Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
Primary Outcome Measure Information:
Title
Structure autism screening instrument administered
Description
Physicians are reminded by the computer system to screen children under 3 years of age for autism with a structured screening instrument. Chart abstraction is used to document whether or not the screening occurred.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Are appropriate diagnostic studies conducted among children who screen positive for autism.
Description
Among children who a suspected of having autism, chart abstraction and interviews are done to determine if the child received appropriate diagnostic and studies.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study. Exclusion Criteria: Previously known autism spectrum disorders or other causes of developmental delay
Facility Information:
Facility Name
Wishard (Eskenazi) Healthcare clinics
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31851348
Citation
Downs SM, Bauer NS, Saha C, Ofner S, Carroll AE. Effect of a Computer-Based Decision Support Intervention on Autism Spectrum Disorder Screening in Pediatric Primary Care Clinics: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2019 Dec 2;2(12):e1917676. doi: 10.1001/jamanetworkopen.2019.17676.
Results Reference
derived

Learn more about this trial

Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism

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