NCT01143701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
577

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
5 months until next milestone

Results Posted

Study results publicly available

November 8, 2016

Completed
Last Updated

November 8, 2016

Status Verified

September 1, 2016

Enrollment Period

5 years

First QC Date

June 11, 2010

Results QC Date

July 26, 2016

Last Update Submit

September 21, 2016

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

  • Parent-rated ADHD Symptoms

    Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.

    12 months

  • Teacher-rated ADHD Symptoms

    Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.

    12 months

Study Arms (2)

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.

Other: ADHD Collaborative

Typical ADHD care

NO INTERVENTION

Physicians in this group will provide typical ADHD care.

Interventions

ADHD CollaborativeOTHER

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.

ADHD Collaborative Intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Childrens Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (5)

  • Gordon MK, Baum RA, Gardner W, Kelleher KJ, Langberg JM, Brinkman WB, Epstein JN. Comparison of Performance on ADHD Quality of Care Indicators: Practitioner Self-Report Versus Chart Review. J Atten Disord. 2020 Aug;24(10):1457-1461. doi: 10.1177/1087054715624227. Epub 2016 Jan 28.

    PMID: 26823383BACKGROUND

  • Brinkman WB, Baum R, Kelleher KJ, Peugh J, Gardner W, Lichtenstein P, Langberg J, Epstein JN. Relationship Between Attention-Deficit/Hyperactivity Disorder Care and Medication Continuity. J Am Acad Child Adolesc Psychiatry. 2016 Apr;55(4):289-94. doi: 10.1016/j.jaac.2016.02.001. Epub 2016 Feb 5.

    PMID: 27015719BACKGROUND

  • Epstein JN, Kelleher KJ, Baum R, Brinkman WB, Peugh J, Gardner W, Lichtenstein P, Langberg J. Variability in ADHD care in community-based pediatrics. Pediatrics. 2014 Dec;134(6):1136-43. doi: 10.1542/peds.2014-1500. Epub 2014 Nov 3.

    PMID: 25367532BACKGROUND

  • Epstein JN, Langberg JM, Lichtenstein PK, Kolb R, Simon JO. The myADHDportal.com Improvement Program: An innovative quality improvement intervention for improving the quality of ADHD care among community-based pediatricians. Clin Pract Pediatr Psychol. 2013 Mar 1;1(1):55-67. doi: 10.1037/cpp0000004.

    PMID: 24163788BACKGROUND

  • Epstein JN, Kelleher KJ, Baum R, Brinkman WB, Peugh J, Gardner W, Lichtenstein P, Langberg JM. Impact of a Web-Portal Intervention on Community ADHD Care and Outcomes. Pediatrics. 2016 Aug;138(2):e20154240. doi: 10.1542/peds.2015-4240.

    PMID: 27462065RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Results Point of Contact

Title
Jeff Epstein, Ph.D.
Organization
Cincinnati Children's Hospital Medical Center
jeff.epstein@cchmc.org
5136368296

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2015

Study Completion

June 1, 2016

Last Updated

November 8, 2016

Results First Posted

November 8, 2016

Record last verified: 2016-09

Locations

US(1)