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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
University of Colorado, Denver
QED Clinical, Inc
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
American Academy of Pediatrics
ClinicalTrials.gov Identifier:
NCT01769300
First received: January 11, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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).


Condition Intervention
Attention Deficit-hyperactivity Disorder
Behavioral: Clinical decision support for medication titration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by American Academy of Pediatrics:

Primary Outcome Measures:
  • Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale. [ Time Frame: 4 & 6 months after enrollment ] [ Designated as safety issue: No ]
    This intervention study tests a clinical decision support system for ADHD treatment.


Secondary Outcome Measures:
  • Side effects as reported on the ADHD Vanderbilt Scale. [ Time Frame: 4 & 6 months after enrollment ] [ Designated as safety issue: No ]
    We will compare side effects between the intervention and control groups.


Estimated Enrollment: 450
Study Start Date: January 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769300

Locations
United States, Illinois
American Academy of Pediatrics
Elk Grove Village, Illinois, United States, 60007
Sponsors and Collaborators
American Academy of Pediatrics
University of Colorado, Denver
QED Clinical, Inc
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Richard C Wasserman, MD, MPH University of Vermont
Principal Investigator: Alexander G Fiks, MD, MSCE Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: American Academy of Pediatrics
ClinicalTrials.gov Identifier: NCT01769300     History of Changes
Other Study ID Numbers: UB5MC20286
Study First Received: January 11, 2013
Last Updated: January 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Pediatrics:
Clinical decision support
Electronic health records
Electronic medical records
Attention deficit-hyperactivity disorder
Primary care Pediatric research network

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014