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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01143701
• Other study ID #: MH083665
• Secondary ID: 1R01MH083665-01A
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 11, 2010
• Last updated: December 28, 2015
• Start date: May 2010
• Est. completion date: June 2016

Study information

• Verified date: December 2015
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 576
• Est. completion date: June 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 11 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Childrens Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parent-rated ADHD symptoms	Parent ratings on Vanderbilt ADHD Rating Scale	12 months	No
Primary	Teacher-rated ADHD symptoms	Teacher ratings of ADHD symptoms on Vanderbile ADHD Rating Scale	12 months	No