NCT01351064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

December 18, 2015

Completed
Last Updated

January 25, 2016

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

May 9, 2011

Results QC Date

November 17, 2015

Last Update Submit

December 18, 2015

Conditions

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

  • Number of Children Diagnosed With ADHD With Structured Diagnostic Assessment

    one year

Secondary Outcomes (1)

  • Percent of Patients Receiving ADHD Care Component

    one year

Study Arms (2)

CHICA ADHD Module

EXPERIMENTAL

This arm received The CHICA ADHD Module

Other: CHICA ADHD Module

CHICA ADHD Control

NO INTERVENTION

This arm received CHICA without the ADHD module

Interventions

This module was added to CHICA to help diagnose and manage ADHD

CHICA ADHD Module

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child between age 5 and 12 years seen in one of our clinics

You may not qualify if:

  • Child outside the age range or who is not seen in one of our clinics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Health Services Research

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Aaron Carroll
Organization
IUSM

Study Officials

  • Aaron E Carroll, MD, MS

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof of Pediatrics

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

July 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

January 25, 2016

Results First Posted

December 18, 2015

Record last verified: 2015-12

Locations