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

NCT ID: NCT01143701

Last Updated: 2016-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

ADHD Collaborative

Intervention Type OTHER

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.

Typical ADHD care

Physicians in this group will provide typical ADHD care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Jeff Epstein

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nationwide Childrens Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26823383 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27015719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25367532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24163788 (View on PubMed)

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.

Reference Type RESULT
PMID: 27462065 (View on PubMed)

Other Identifiers

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1R01MH083665-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH083665

Identifier Type: -

Identifier Source: org_study_id