Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder (ePROS)
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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 |
- 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.
- 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 |
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| United States, Illinois | |
| American Academy of Pediatrics | |
| Elk Grove Village, Illinois, United States, 60007 | |
| Principal Investigator: | Richard C Wasserman, MD, MPH | University of Vermont |
| Principal Investigator: | Alexander G Fiks, MD, MSCE | Children's Hospital of Philadelphia |
More Information
Additional 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 Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013