Attention Deficit Hyperactivity DisorderNCT01351064
Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
A study testing CHICA ADHD Module in people with Attention Deficit Hyperactivity Disorder, run by Indiana University at 1 site in United States.
Trial summary
Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder in children. Prevalence rates in the United States range from 2% to 18% depending on diagnostic criteria and population studied. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- CHICA ADHD Module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child between age 5 and 12 years seen in one of our clinics
Who cannot join
- Child outside the age range or who is not seen in one of our clinics.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Health Services Research
Indianapolis, Indiana, 46202
About this study
Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder in children. Prevalence rates in the United States range from 2% to 18% depending on diagnostic criteria and population studied. Primary care physicians, especially pediatricians, have historically played a large role in the diagnosis and treatment of ADHD. Despite the existence of authoritative guidelines to assist primary care physicians, ample evidence demonstrates that they continue to diagnose and treat this disorder suboptimally. This is due, in part, to a lack of training and cumbersome delivery system designs. Modern computer decision support strategies offer the best hope of equipping general practitioners to deal with the mental health epidemic of ADHD.
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment guidelines. The investigators hypothesize that implementation of the ADHD guidelines will result in better outcomes, including higher rates of adherence to recommendations and improved patient functioning.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder in children. Prevalence rates in the United States range from 2% to 18% depending on diagnostic criteria and population studied. Primary care physicians, especially pediatricians, have historically played a large role in the diagnosis and treatment of ADHD. Despite the existence of authoritative guidelines to assist primary care physicians, ample evidence demonstrates that they continue to diagnose and treat this disorder suboptimally. This is due, in part, to a lack of training and cumbersome delivery system designs. Modern computer decision support strategies offer the best hope of equipping general practitioners to deal with the mental health epidemic of ADHD.
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment guidelines. The investigators hypothesize that implementation of the ADHD guidelines will result in better outcomes, including higher rates of adherence to recommendations and improved patient functioning.
The specific research aims of this proposal are:
Aim 1: Expand and modify an existing computer-based decision support system (CHICA) to include ADHD treatment and diagnosis guideline rules as well as the capability to fax data directly into the medical record.
Aim 2: Evaluate the effect of the CHICA system on the processes of ADHD care in pediatric practices, including adherence to guidelines for ADHD treatment and diagnosis.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- CHICA ADHD Module
- Keywords
- ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA ADHD ModuleOther
This module was added to CHICA to help diagnose and manage ADHD
| Study group | Role | What they receive |
|---|---|---|
| CHICA ADHD Module | Experimental | This arm received The CHICA ADHD Module Receives: Other: CHICA ADHD Module |
| CHICA ADHD Control | No intervention | This arm received CHICA without the ADHD module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment
Measured: one year
Secondary outcomes (1)
Percent of Patients Receiving ADHD Care Component
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Aaron Carroll, Indiana University
- Investigators
- Aaron E Carroll, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351064
- Sponsor's protocol ID
- CHICA_ADHD_Study
- Other IDs
- R01LM010031
- Status last verified
- Dec 2015
- First submitted
- 9 May 2011
- Last updated
- 25 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.
PubMed 23958768
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01351064
- Acronym / sponsor ID
- CHICA_ADHD_Study
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 18 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder in children. Prevalence rates in the United States range from 2% to 18% depending on diagnostic criteria and population studied. Primary care physicians, especially pediatricians, have historically played a large role in the diagnosis and treatment of ADHD. Despite the existence of authoritative guidelines to assist primary care physicians, ample evidence demonstrates that they continue to diagnose and treat this disorder suboptimally. This is due, in part, to a lack of training and cumbersome delivery system designs. Modern computer decision support strategies offer the best hope of equipping general practitioners to deal with the mental health epidemic of ADHD.
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment guidelines. The investigators hypothesize that implementation of the ADHD guidelines will result in better outcomes, including higher rates of adherence to recommendations and improved patient functioning.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is the most commonly diagnosed behavioral disorder in children. Prevalence rates in the United States range from 2% to 18% depending on diagnostic criteria and population studied. Primary care physicians, especially pediatricians, have historically played a large role in the diagnosis and treatment of ADHD. Despite the existence of authoritative guidelines to assist primary care physicians, ample evidence demonstrates that they continue to diagnose and treat this disorder suboptimally. This is due, in part, to a lack of training and cumbersome delivery system designs. Modern computer decision support strategies offer the best hope of equipping general practitioners to deal with the mental health epidemic of ADHD.
The investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practice. CHICA (Child Health Improvement through Computer Automation) combines three elements: (1) pediatric guidelines encoded in Arden Syntax; (2) a dynamic, scannable paper user interface; and (3) an HL7-compliant interface to existing electronic medical record systems. The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter, and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines. The investigators propose to expand CHICA to include ADHD diagnosis and treatment guidelines. The investigators hypothesize that implementation of the ADHD guidelines will result in better outcomes, including higher rates of adherence to recommendations and improved patient functioning.
The specific research aims of this proposal are:
Aim 1: Expand and modify an existing computer-based decision support system (CHICA) to include ADHD treatment and diagnosis guideline rules as well as the capability to fax data directly into the medical record.
Aim 2: Evaluate the effect of the CHICA system on the processes of ADHD care in pediatric practices, including adherence to guidelines for ADHD treatment and diagnosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHICA ADHD Module | Experimental | Other: CHICA ADHD ModuleThis arm received The CHICA ADHD Module |
| CHICA ADHD Control | No intervention | –This arm received CHICA without the ADHD module |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child between age 5 and 12 years seen in one of our clinics
Key exclusion criteria (1 listed)
- Child outside the age range or who is not seen in one of our clinics.
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 |
|---|---|---|
| CHICA ADHD ModuleThis module was added to CHICA to help diagnose and manage ADHD | Other | CHICA ADHD Module |
Primary outcome
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment
Time frame: one year
1 secondary outcome
Percent of Patients Receiving ADHD Care Component
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23958768Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.
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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.
Aaron E Carroll, MD, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA ADHD Module in people with Attention Deficit Hyperactivity Disorder, 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 25 Jan 2016. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment (time frame: one year). 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 NCT01351064, 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 25 Jan 2016.