Clinical trial NCT01769300: Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
Official title: Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention Deficit-hyperactivity Disorder
Keywords: Clinical decision support
Electronic health records
Electronic medical records
Attention deficit-hyperactivity disorder
Primary care Pediatric research network
Lead sponsor: American Academy of Pediatrics
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
name: QED Clinical, Inc
name: Children's Hospital of Philadelphia
First posted: 2013-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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 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

Primary outcomes:
measure: Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.
timeFrame: 4 & 6 months after enrollment
Secondary outcomes:
measure: Side effects as reported on the ADHD Vanderbilt Scale.
timeFrame: 4 & 6 months after enrollment
Other outcomes:
Locations:
city: Elk Grove Village
country: United States
facility: American Academy of Pediatrics
state: Illinois
Study officials:
affiliation: University of Vermont
name: Richard C Wasserman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Alexander G Fiks, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: