Young Hearts, Strong Starts

Phase 4

Completed

• Conditions: Cardiovascular Risk Reduction
• Interventions: Other: Intervention; Other: Control

• Registration Number: NCT01893593
• Lead Sponsor: RTI International

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-12
• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-02
• Study First Posted: 2013-07-09
• Study Completion: 2013-10
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients seen for well child visits

Exclusion Criteria

• Terminally ill patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Intervention	Multifaceted intervention to improve clinical systems
Control	Control	Usual care

Primary Outcome Measures

Name	Time	Method
Summary composite measure of practice performance and exposure	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 Outcome Measures

Name	Time	Method
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure	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.

Trial Locations

Locations (2)

Lurie Children's Hospital; 🇺🇸 Chicago, Illinois, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States