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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Attention Deficit-hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Clinical decision support for medication titration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network