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Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care

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ClinicalTrials.gov Identifier: NCT01143701
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : November 8, 2016
Last Update Posted : November 8, 2016
Sponsor:
Collaborators:
Nationwide Children's Hospital
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jeff Epstein, Children's Hospital Medical Center, Cincinnati

Study Description
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Brief Summary:
ADHD is the most prevalent mental health disorder of childhood. The majority of children with ADHD receive their care in primary care settings. While the American Academy of Pediatrics (AAP) issued evidence-based guidelines and recommendations for pediatricians, most pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in evidence-based ADHD care and the likely effects on child outcomes, the development and testing of interventions aimed at improving ADHD care in primary care settings is necessary. Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. This intervention model has been used to train over 200 physicians at 55 practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold increases in the use of evidence-based ADHD-related practice behaviors in participating physicians. To date, the intervention has been implemented as a quality improvement project with few experimental controls. The primary goal of the proposed study is to conduct an experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention. Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD patients will be included in the study. Chart reviews, parental interviews, and parent and teacher rating scales will be collected. Between- and within-group hierarchical linear modeling analyses will examine whether the intervention produces significant improvements in pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative intervention over typical care will be established by computing incremental cost-effectiveness ratios using cost and effect size estimates.

Condition or disease Intervention/treatment Phase
ADHD Other: ADHD Collaborative Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 577 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care
Study Start Date : May 2010
Actual Primary Completion Date : May 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ADHD Collaborative Intervention
The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.
 Other: ADHD Collaborative
The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines.
No Intervention: Typical ADHD care
Physicians in this group will provide typical ADHD care.


Outcome Measures
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Primary Outcome Measures :
  1. Parent-rated ADHD Symptoms [ Time Frame: 12 months ]
    Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.

  2. Teacher-rated ADHD Symptoms [ Time Frame: 12 months ]
    Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Practice must have a minimum of two pediatricians who agree to participate.
  • Practice must have an electronic billing system.
  • Practice must have internet access at office.
  • Practice must not have an on-site mental health professional.
  • Practice must have a member of practice staff willing to be trained in human subjects certification and willing to consent families.
  • Children must be in Grade 1-5.
  • Children must be newly diagnosed with ADHD.

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143701


Locations
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United States, Ohio
Nationwide Childrens Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Nationwide Children's Hospital
National Institute of Mental Health (NIMH)
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Jeff Epstein, Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01143701    
Other Study ID Numbers: MH083665
1R01MH083665-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2010    Key Record Dates
Results First Posted: November 8, 2016
Last Update Posted: November 8, 2016
Last Verified: September 2016