Cardiovascular Risk Reduction Clinical Trial
Official title:
A Cluster Randomized Trial of the Implementation of the NHLBI Expert Panel Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Recruiting |
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N/A |