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

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).

Study Overview

• Status: Withdrawn
• Conditions: Attention Deficit-hyperactivity Disorder
• Intervention / Treatment: Behavioral: Clinical decision support for medication titration

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • American Academy of Pediatrics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control practices; Practices that do not use the ADHD clinical decision support
Experimental: Clinical decision support; Electronic health record-based clinical decision support for ADHD medication titration.	Behavioral: Clinical decision support for medication titration; Electronic health record-based clinical decision support for ADHD medication titration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects as reported on the ADHD Vanderbilt Scale.	We will compare side effects between the intervention and control groups.	4 & 6 months after enrollment

Collaborators and Investigators

• Sponsor: American Academy of Pediatrics
• Collaborators: University of Colorado, Denver; Children's Hospital of Philadelphia; QED Clinical, Inc
• Investigators: Principal Investigator: Alexander G Fiks, MD, MSCE, Children's Hospital of Philadelphia; Principal Investigator: Richard C Wasserman, MD, MPH, University of Vermont

Publications and helpful links

Helpful Links

• ePROS website

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 16, 2013

Study Record Updates

• Last Update Posted (Actual): July 13, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Electronic medical records; Clinical decision support; Electronic health records; Attention deficit-hyperactivity disorder; Primary care Pediatric research network
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: UB5MC20286