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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01769300
Acronym
ePROS
Enrollment
0
Registered
2013-01-16
Start date
2013-01-31
Completion date
2014-08-31
Last updated
2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit-hyperactivity Disorder

Keywords

Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network

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.

Interventions

BEHAVIORALClinical decision support for medication titration

Electronic health record-based clinical decision support for ADHD medication titration.

Sponsors

University of Colorado, Denver
CollaboratorOTHER
QED Clinical, Inc
CollaboratorUNKNOWN
Children's Hospital of Philadelphia
CollaboratorOTHER
American Academy of Pediatrics
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.4 & 6 months after enrollmentThis intervention study tests a clinical decision support system for ADHD treatment.

Secondary

MeasureTime frameDescription
Side effects as reported on the ADHD Vanderbilt Scale.4 & 6 months after enrollmentWe will compare side effects between the intervention and control groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026