Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder

NCT ID: NCT01769300

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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).

Detailed Description

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In this cluster (site)-randomized trial of clinical decision support for ADHD medication titration, clinicians caring for children with ADHD whose families are initiating stimulant medication at that practice will be followed.

Two groups will be compared; an intervention group, which will receive the intervention-the clinical decision support (CDS)--, and a control group, who will not receive CDS. Over a 6-month period, the CDS will support guideline-based medication titration to achieve optimal symptom control with minimal side effects. The study will track the care delivered to affected children by the practitioners and will assess the endpoints of symptom reduction and side effects. There will also be a sub-study within the larger study which will give the team a better understanding about the pros and cons of consenting parents over the phone.

Conditions

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Attention Deficit-hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Control practices

Practices that do not use the ADHD clinical decision support

Group Type NO_INTERVENTION

No interventions assigned to this group

Clinical decision support

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

Group Type EXPERIMENTAL

Clinical decision support for medication titration

Intervention Type BEHAVIORAL

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

Interventions

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Clinical decision support for medication titration

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

QED Clinical, Inc

UNKNOWN

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard C Wasserman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Alexander G Fiks, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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American Academy of Pediatrics

Elk Grove Village, Illinois, United States

Site Status

Countries

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United States

Related Links

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http://www.aap.org/

ePROS website

Other Identifiers

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UB5MC20286

Identifier Type: -

Identifier Source: org_study_id

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