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Clinical Trials/NCT01143701
NCT01143701CompletedPhase 4

Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care

Children's Hospital Medical Center, Cincinnati1 site in 1 country577 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
577
Locations
1
Primary Endpoint
Parent-rated ADHD Symptoms

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Single (Care Provider)

Eligibility Criteria

Ages
6 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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-
  • •Children must be newly diagnosed with ADHD.

Exclusion Criteria

  • Not provided

Arms & Interventions

ADHD Collaborative Intervention

Experimental

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.

Intervention: ADHD Collaborative (Other)

Typical ADHD care

No Intervention

Physicians in this group will provide typical ADHD care.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jeff Epstein

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Study Sites (1)

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