- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612897
Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism (CAAC)
March 23, 2015 updated by: Indiana University
Computer Assisted Autism Care (CAAC)
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
368
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Indiana
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Indianapolis, Indiana, United States, 46202
- Wishard (Eskenazi) Healthcare clinics
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computer based reminders to MD
Children in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism.
|
Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
|
No Intervention: Usual care arm
Children in this are receive usual care from a clinic randomly chosen to serve as a control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Structure autism screening instrument administered
Time Frame: Up to 4 years
|
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.
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Up to 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Are appropriate diagnostic studies conducted among children who screen positive for autism.
Time Frame: Up to 4 years
|
Among children who a suspected of having autism, chart abstraction and interviews are done to determine if the child received appropriate diagnostic and studies.
|
Up to 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
June 4, 2012
First Submitted That Met QC Criteria
June 5, 2012
First Posted (Estimate)
June 6, 2012
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 23, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HS018453 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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