NCT01769300

Brief Summary

The specific aim of this cluster-randomized (site) comparative effectiveness research study is to determine whether children who are (1) 5-12 years of age, (2) cared for in ePROS practices or clinics using an electronic health record (EHR), (3) have attention-deficit hyperactivity disorder (ADHD), and (4) are to receive treatment with stimulant medication for the first time in these practices, have superior clinical outcomes if their clinicians have access to an EHR-guided clinical decision support system (intervention group) than if their clinicians have no such access (control group).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

1.6 years

First QC Date

January 11, 2013

Last Update Submit

July 11, 2018

Conditions

Attention Deficit-hyperactivity Disorder

Keywords

Clinical decision supportElectronic health recordsElectronic medical recordsAttention deficit-hyperactivity disorderPrimary care Pediatric research network

Outcome Measures

Primary Outcomes (1)

  • Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.

    This intervention study tests a clinical decision support system for ADHD treatment.

    4 & 6 months after enrollment

Secondary Outcomes (1)

  • Side effects as reported on the ADHD Vanderbilt Scale.

    4 & 6 months after enrollment

Study Arms (2)

Control practices

NO INTERVENTION

Practices that do not use the ADHD clinical decision support

Clinical decision support

EXPERIMENTAL

Electronic health record-based clinical decision support for ADHD medication titration.

Behavioral: Clinical decision support for medication titration

Interventions

Clinical decision support for medication titrationBEHAVIORAL

Electronic health record-based clinical decision support for ADHD medication titration.

Clinical decision support

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Practice Eligibility Criteria * Willing to offer the possibility of study enrollment to their patients who have ADHD * Willing to use the Vanderbilt Assessment Rating Scale to assess and potentially, to monitor ADHD for study subjects * Utilize Integrated Health Connect as a means to collect the Vanderbilt Assessment Rating Scale * Use point-of-care reports for subjects enrolled in the study. Patient Eligibility Criteria * The child must be between the ages of 5-12 years old * The child must be starting stimulant medication for the first time * Parent must be able to speak and read English * The child must not be diagnosed with a current manic episode, a psychotic disorder, or a pervasive developmental disorder (e.g. autism, Asperger's, Rett's disorder) * The child must not have reported suicidality or have conduct disorder, per parent/guardian report

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

American Academy of Pediatrics

Elk Grove Village, Illinois, 60007, United States

Location

Related Links

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Richard C Wasserman, MD, MPH

    University of Vermont

    PRINCIPAL INVESTIGATOR

  • Alexander G Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

US(1)