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

Attention Deficit-hyperactivity Disorder Clinical Trial

— ePROS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01769300
• Other study ID #: UB5MC20286
• Status: Withdrawn
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: July 2018
• Source: American Academy of Pediatrics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit-hyperactivity Disorder
• Disease
• Hyperkinesis

Intervention

Behavioral:
• Clinical decision support for medication titration
Electronic health record-based clinical decision support for ADHD medication titration.

Locations

Country	Name	City	State
United States	American Academy of Pediatrics	Elk Grove Village	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
American Academy of Pediatrics	Children's Hospital of Philadelphia, QED Clinical, Inc, University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   ePROS website