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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01351064
Other study ID # CHICA_ADHD_Study
Secondary ID R01LM010031
Status Completed
Phase N/A
First received May 9, 2011
Last updated December 18, 2015
Start date July 2010
Est. completion date July 2012

Study information

Verified date December 2015
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 12 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Other:
CHICA ADHD Module
This module was added to CHICA to help diagnose and manage ADHD

Locations

Country Name City State
United States Children's Health Services Research Indianapolis Indiana

Sponsors (2)

Lead Sponsor Collaborator
Indiana University National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment one year No
Secondary Percent of Patients Receiving ADHD Care Component one year No
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