Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
32 participants
INTERVENTIONAL
2011-11-30
2013-10-31
Brief Summary
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Detailed Description
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Methods: Two primary care research networks recruited practices and provided support for the intervention and outcome evaluations. Individual practices were randomly assigned to either the intervention or control groups using a cluster randomized design based on network affiliation, number of clinicians per practice, urban vs. nonurban location, and practice type. In this design, the units of observation are individual children because outcomes are abstracted from medical records for individual patients. The units of randomization are physician practices. This results in a multilevel design in which patients are nested within practices. Implementation The intervention practices receive toolkits, including guideline summaries and slides, a patient and family behavior change workbook, and a clinical decision support tool. Guideline implementation was promoted through an introductory academic detailing session and the use of an ongoing e-learning group. The intervention strategy was further enhanced by aligning this project with the American Board of Pediatrics quality improvement Maintenance of Certification (MOC) requirements and offers voluntary MOC participation to participants. MOC participation includes the creation of a practice aims statement, monthly physician self-abstraction to track progress throughout the intervention, and participation in webinar presentations and sharing of best practices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Usual care
Control
Guideline summary and data feedback from a baseline medical record review
Intervention
Multifaceted intervention to improve clinical systems
Intervention
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
Interventions
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Intervention
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
Control
Guideline summary and data feedback from a baseline medical record review
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Years
11 Years
ALL
No
Sponsors
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East Carolina University
OTHER
Pediatric Practice Research Group
NETWORK
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
RTI International
OTHER
Responsible Party
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Principal Investigators
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Ken LaBresh, MD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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Lurie Children's Hospital
Chicago, Illinois, United States
East Carolina University
Greenville, North Carolina, United States
Countries
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References
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LaBresh KA, Ariza AJ, Lazorick S, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Salinas IG, Bender RH, Binns HJ. Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial. Pediatrics. 2014 Sep;134(3):e732-8. doi: 10.1542/peds.2014-0876.
LaBresh KA, Lazorick S, Ariza AJ, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Bender RH, Salinas IG, Binns HJ. Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco. Contemp Clin Trials. 2014 Jan;37(1):98-105. doi: 10.1016/j.cct.2013.11.011. Epub 2013 Dec 1.
Other Identifiers
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Young Hearts, Strong Starts
Identifier Type: -
Identifier Source: org_study_id
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