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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01056016
Other study ID # R21MH082714
Secondary ID
Status Completed
Phase N/A
First received January 22, 2010
Last updated February 9, 2012
Start date July 2009
Est. completion date December 2010

Study information

Verified date February 2012
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

The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow. These guidelines can be challenging to implement in typical community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians. The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes. The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice. Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination. The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A transportable intervention is described that utilizes telehealth videoconferencing, a web portal, and long-distance data collection. Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology. Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual). Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date December 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- pediatric practice with at least 2 physicians

Exclusion Criteria:

- no electronic billing system

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis

Intervention

Other:
ADHD Collaborative
This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales.

Locations

Country Name City State
United States Cincinnati Childrens Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

Epstein JN, Langberg JM, Lichtenstein PK, Mainwaring BA, Luzader CP, Stark LJ. Community-wide intervention to improve the attention-deficit/hyperactivity disorder assessment and treatment practices of community physicians. Pediatrics. 2008 Jul;122(1):19-27. doi: 10.1542/peds.2007-2704. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Physician ADHD practice behavior 6 months No
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