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OpenTrials
Completed

NCT Number: NCT01893593

Young Hearts, Strong Starts

This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lurie Children's Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients seen for well child visits

Exclusion criteria

  • Terminally ill patients

Treatment and study plan

Intervention

Other

Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems

Control

Other

Guideline summary and data feedback from a baseline medical record review

Primary outcomes

  1. Summary composite measure of practice performance and exposure

    Time frame: One year

    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.

Secondary outcomes

  1. Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure

    Time frame: One year

    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.

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • East Carolina University
  • Pediatric Practice Research Group

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 9, 2013
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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