Attention Deficit-hyperactivity DisorderePROSNCT01769300
Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
A study testing Clinical decision support for medication titration in people with Attention Deficit-hyperactivity Disorder, run by American Academy of Pediatrics at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit-hyperactivity Disorder
- What is being tested?
- Clinical decision support for medication titration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Pediatrics
Elk Grove Village, Illinois, 60007
About this study
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).
Read the 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.
- Conditions
- Attention Deficit-hyperactivity Disorder
- Being tested
- Clinical decision support for medication titration
- Keywords
- Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support for medication titrationBehavioural
Electronic health record-based clinical decision support for ADHD medication titration.
| Study group | Role | What they receive |
|---|---|---|
| Control practices | No intervention | Practices that do not use the ADHD clinical decision support |
| Clinical decision support | Experimental | Electronic health record-based clinical decision support for ADHD medication titration. Receives: Behavioral: Clinical decision support for medication titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.
This intervention study tests a clinical decision support system for ADHD treatment.
Measured: 4 & 6 months after enrollment
Secondary outcomes (1)
Side effects as reported on the ADHD Vanderbilt Scale.
We will compare side effects between the intervention and control groups.
Measured: 4 & 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit-hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Academy of Pediatrics
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, QED Clinical, Inc, Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Richard C Wasserman, MD, MPH, Principal investigator, University of VermontAlexander G Fiks, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769300
- Sponsor's protocol ID
- UB5MC20286
- Acronym
- ePROS
- Status last verified
- Jul 2018
- First submitted
- 11 Jan 2013
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Medication Management of Patients With Attention-Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01769300
- Acronym / sponsor ID
- ePROS / UB5MC20286
- Conditions
- Attention Deficit-hyperactivity Disorder
- Keywords
- Clinical decision support, Electronic health records, Electronic medical records, Attention deficit-hyperactivity disorder, Primary care Pediatric research network
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American Academy of PediatricsUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, QED Clinical, Inc, Children's Hospital of Philadelphia
- Study start
- Jan 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 16 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control practices | No intervention | –Practices that do not use the ADHD clinical decision support |
| Clinical decision support | Experimental | Behavioral: Clinical decision support for medication titrationElectronic health record-based clinical decision support for ADHD medication titration. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical decision support for medication titrationElectronic health record-based clinical decision support for ADHD medication titration. | Behavioural | Clinical decision support |
Primary outcome
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale.
Time frame: 4 & 6 months after enrollment
This intervention study tests a clinical decision support system for ADHD treatment.
1 secondary outcome
Side effects as reported on the ADHD Vanderbilt Scale.
Time frame: 4 & 6 months after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- ePROS websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard C Wasserman, MD, MPH principal investigator
University of Vermont
Alexander G Fiks, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support for medication titration in people with Attention Deficit-hyperactivity Disorder, run by American Academy of Pediatrics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in symptoms, as measured by the parent-reported Vanderbilt Assessment Scale. (time frame: 4 & 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.