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

• Sponsor: American Academy of Pediatrics (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01769300
• Collaborator: University of Colorado, Denver (Other), QED Clinical, Inc (Other), Children's Hospital of Philadelphia (Other)
• Enrollment: 0
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 0

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit-hyperactivity Disorder	Behavioral: Clinical decision support for medication titration	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale. [4 & 6 months after enrollment]

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

Secondary Outcome Measures

1. Side effects as reported on the ADHD Vanderbilt Scale. [4 & 6 months after enrollment]

   We will compare side effects between the intervention and control groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• ePROS website

Publications

None provided.

• Responsible Party: American Academy of Pediatrics
• ClinicalTrials.gov Identifier: NCT01769300
• Other Study ID Numbers: UB5MC20286
• First Posted: Jan 16, 2013
• Last Update Posted: Jul 13, 2018
• Last Verified: Jul 1, 2018

• 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: Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity

Study Results

No Results Posted as of Jul 13, 2018