Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHICA ADHD Module
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD
Eligibility Criteria
Inclusion Criteria:
- Child between age 5 and 12 years seen in one of our clinics
Exclusion Criteria:
- Child outside the age range or who is not seen in one of our clinics.
Sites / Locations
- Children's Health Services Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CHICA ADHD Module
CHICA ADHD Control
Arm Description
This arm received The CHICA ADHD Module
This arm received CHICA without the ADHD module
Outcomes
Primary Outcome Measures
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment
Secondary Outcome Measures
Percent of Patients Receiving ADHD Care Component
Full Information
NCT ID
NCT01351064
First Posted
May 9, 2011
Last Updated
December 18, 2015
Sponsor
Indiana University
Collaborators
National Library of Medicine (NLM)
1. Study Identification
Unique Protocol Identification Number
NCT01351064
Brief Title
Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Official Title
Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Library of Medicine (NLM)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CHICA ADHD Module
Arm Type
Experimental
Arm Description
This arm received The CHICA ADHD Module
Arm Title
CHICA ADHD Control
Arm Type
No Intervention
Arm Description
This arm received CHICA without the ADHD module
Intervention Type
Other
Intervention Name(s)
CHICA ADHD Module
Intervention Description
This module was added to CHICA to help diagnose and manage ADHD
Primary Outcome Measure Information:
Title
Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment
Time Frame
one year
Secondary Outcome Measure Information:
Title
Percent of Patients Receiving ADHD Care Component
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Child between age 5 and 12 years seen in one of our clinics
Exclusion Criteria:
Child outside the age range or who is not seen in one of our clinics.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron E Carroll, MD, MS
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Health Services Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23958768
Citation
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.
Results Reference
derived
Learn more about this trial
Using Computers to Assist in the Diagnosis and Treatment of Attention-deficit/Hyperactivity Disorder (ADHD)
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