A Phase 4 interventional study of Intervention and Control in Cardiovascular Risk Reduction, sponsored by RTI International. Completed at 2 sites in United States. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by RTI International · Phase 4, Interventional, and Prevention
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
Objective: The Young Hearts Strong Starts Study was designed to test strategies to facilitate adoption of the Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents among pediatric and family medicine providers. The study compares quality measures based on the guidelines for two dissemination strategies: a multi-faceted, practice-directed intervention or standard dissemination.
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.
RTI International is the lead sponsor of 81 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care
Other: Control
Multifaceted intervention to improve clinical systems
Other: Intervention
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
Guideline summary and data feedback from a baseline medical record review
Summary composite measure of practice performance and exposure
Summary measures of the number of guideline recommended actions in each area divided by the number of eligible patients. Process measures of adherence to guidelines in the measurement, interpretation, and recommendations for blood pressue and BMI, and measures of assessment and advice for tobacco exposure and use.
Time frame: One year
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
Process measures of adherence to guidelines in the measurement, interpretation, and recommendations for blood pressue and BMI, and measures of assessment and advice for tobacco exposure and use.
Time frame: One year
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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RTI International