- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01056016
Disseminating a Model Intervention to Promote Improved Attention-deficit Hyperactivity Disorder (ADHD) Care in the Community
October 31, 2016 updated by: Jeff Epstein, Children's Hospital Medical Center, Cincinnati
Disseminating a Model Intervention to Promote Improved ADHD Care in the Community
The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow.
These guidelines can be challenging to implement in typical community-based practices.
Cincinnati Children's Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians.
The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes.
The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice.
Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination.
The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs..
A transportable intervention is described that utilizes telehealth videoconferencing, a web portal, and long-distance data collection.
Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology.
Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual).
Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline.
The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Childrens Hospital Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pediatric practice with at least 2 physicians
Exclusion Criteria:
- no electronic billing system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Wait-list control
Wait-list control group
|
|
Experimental: ADHD Collaborative Intervention
This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD.
Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g.
Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a Diagnostic and Statistical Manual-IV (DSM-IV) based ADHD diagnosis.
Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales.
The intervention lasts for 6 months.
|
This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD.
Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g.
Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis.
Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician ADHD Practice Behavior
Time Frame: Baseline and 6 months
|
Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response
|
Baseline and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Epstein JN, Langberg JM, Lichtenstein PK, Mainwaring BA, Luzader CP, Stark LJ. Community-wide intervention to improve the attention-deficit/hyperactivity disorder assessment and treatment practices of community physicians. Pediatrics. 2008 Jul;122(1):19-27. doi: 10.1542/peds.2007-2704.
- Epstein JN, Langberg JM, Lichtenstein PK, Kolb R, Altaye M, Simon JO. Use of an Internet portal to improve community-based pediatric ADHD care: a cluster randomized trial. Pediatrics. 2011 Nov;128(5):e1201-8. doi: 10.1542/peds.2011-0872. Epub 2011 Oct 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
January 22, 2010
First Submitted That Met QC Criteria
January 25, 2010
First Posted (Estimate)
January 26, 2010
Study Record Updates
Last Update Posted (Estimate)
December 23, 2016
Last Update Submitted That Met QC Criteria
October 31, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21MH082714 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Attention Deficit Hyperactivity Disorder
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Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
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Cingulate TherapeuticsPremier Research Group plcActive, not recruitingADHD | Attention Deficit Hyperactivity Disorder | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
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Children's National Research InstituteRecruitingADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | ADD | ADHD Predominantly Inattentive Type | ADHD - Combined Type | ADHD, Predominantly Hyperactive - Impulsive | Attention-Deficit Disorder in Adolescence | Attention-Deficit Hyperactivity...United States
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
University Hospital Bispebjerg and FrederiksbergMental Health Services in the Capital Region, DenmarkRecruitingSleep Disturbance | Neurodevelopmental Disorders | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder | Attention-Deficit Hyperactivity Disorder, Unspecified Type | Attention-deficit Hyperactivity | Hyperkinetic Conduct DisorderDenmark
-
Corium, Inc.Worldwide Clinical Trials; Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Corium, Inc.Premier Research Group plc; Almac; Prometrika, LLCRecruitingAttention Deficit/Hyperactivity DisorderUnited States
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Massachusetts General HospitalShire Human Genetic Therapies, Inc.Active, not recruitingAttention Deficit/Hyperactivity DisorderUnited States
-
Ataturk UniversityCompletedAttention-deficit/Hyperactivity DisorderTurkey
Clinical Trials on ADHD Collaborative
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Children's Hospital Medical Center, CincinnatiNational Institute of Mental Health (NIMH); Nationwide Children's HospitalCompleted
-
The University of Hong KongRecruiting
-
Göteborg UniversityCompleted
-
Children's Hospital Medical Center, CincinnatiTerminated
-
Boston Medical CenterCodman Square Health Center; Dorchester House Health CenterCompletedAttention Deficit/Hyperactivity DisorderUnited States
-
Vanderbilt UniversityCompletedVentilator Associated Pneumonia | Central Line-associated Bloodstream Infection (CLABSI)United States
-
Lumos Labs, Inc.Recruiting
-
Indiana UniversityNational Library of Medicine (NLM)CompletedAttention Deficit Hyperactivity DisorderUnited States
-
University of ArkansasCompleted