Back to resultsImproving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder (ePROS)
Primary Purpose
Attention Deficit-hyperactivity Disorder
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical decision support for medication titration
Sponsored by
About this trial
This is an interventional health services research trial for Attention Deficit-hyperactivity Disorder focused on measuring Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network
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
Sites / Locations
- American Academy of Pediatrics
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control practices
Clinical decision support
Arm Description
Practices that do not use the ADHD clinical decision support
Electronic health record-based clinical decision support for ADHD medication titration.
Outcomes
Primary Outcome Measures
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.
This intervention study tests a clinical decision support system for ADHD treatment.
Secondary Outcome Measures
Side effects as reported on the ADHD Vanderbilt Scale.
We will compare side effects between the intervention and control groups.
Full Information
NCT ID
NCT01769300
First Posted
January 11, 2013
Last Updated
July 11, 2018
Sponsor
American Academy of Pediatrics
Collaborators
University of Colorado, Denver, QED Clinical, Inc, Children's Hospital of Philadelphia
1. Study Identification
Unique Protocol Identification Number
NCT01769300
Brief Title
Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
Acronym
ePROS
Official Title
Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding issues
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Academy of Pediatrics
Collaborators
University of Colorado, Denver, QED Clinical, Inc, Children's Hospital of Philadelphia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit-hyperactivity Disorder
Keywords
Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control practices
Arm Type
No Intervention
Arm Description
Practices that do not use the ADHD clinical decision support
Arm Title
Clinical decision support
Arm Type
Experimental
Arm Description
Electronic health record-based clinical decision support for ADHD medication titration.
Intervention Type
Behavioral
Intervention Name(s)
Clinical decision support for medication titration
Intervention Description
Electronic health record-based clinical decision support for ADHD medication titration.
Primary Outcome Measure Information:
Title
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.
Description
This intervention study tests a clinical decision support system for ADHD treatment.
Time Frame
4 & 6 months after enrollment
Secondary Outcome Measure Information:
Title
Side effects as reported on the ADHD Vanderbilt Scale.
Description
We will compare side effects between the intervention and control groups.
Time Frame
4 & 6 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard C Wasserman, MD, MPH
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander G Fiks, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Academy of Pediatrics
City
Elk Grove Village
State/Province
Illinois
ZIP/Postal Code
60007
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.aap.org/
Description
ePROS website
Learn more about this trial
Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
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