Healthy Children Undergoing Routine CareCAACNCT01612897
Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism
A study testing Computer based care reminders in people with Healthy Children Undergoing Routine Care and Children With Autism, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 months to 4 years
- Conditions the study is for
- Healthy Children Undergoing Routine Care, Children With Autism
- What is being tested?
- Computer based care reminders
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study.
Who cannot join
- Previously known autism spectrum disorders or other causes of developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Wishard (Eskenazi) Healthcare clinics
Indianapolis, Indiana, 46202
About this study
Official title: 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.
Read the 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.
- Being tested
- Computer based care reminders
- Keywords
- autism, well child care, screening, computer, reminders
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer based care remindersOther
Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Computer based reminders to MD | Experimental | Children in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism. Receives: Other: Computer based care reminders |
| Usual care arm | No intervention | Children in this are receive usual care from a clinic randomly chosen to serve as a control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 years
Secondary outcomes (1)
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.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startSep 2009
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Children Undergoing Routine CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612897
- Sponsor's protocol ID
- R01HS018453
- Acronym
- CAAC
- Status last verified
- Mar 2015
- First submitted
- 4 Jun 2012
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31851348
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Autism Care (CAAC)
- ClinicalTrials.gov ID
- NCT01612897
- Acronym / sponsor ID
- CAAC / R01HS018453
- Keywords
- autism, well child care, screening, computer, reminders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer based reminders to MD | Experimental | Other: Computer based care remindersChildren in this arm attend a clinic that is randomly assigned to receive physician alerts to screen appropriate children for autism. |
| Usual care arm | No intervention | –Children in this are receive usual care from a clinic randomly chosen to serve as a control. |
Who may qualify
- Ages
- 17 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study.
Key exclusion criteria (1 listed)
- Previously known autism spectrum disorders or other causes of developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer based care remindersPhysicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic. | Other | Computer based reminders to MD |
Primary outcome
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.
1 secondary outcome
Are appropriate diagnostic studies conducted among children who screen positive for autism.
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 31851348Downs 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer based care reminders in people with Healthy Children Undergoing Routine Care and Children With Autism, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure autism screening instrument administered (time frame: Up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01612897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.