Young Hearts, Strong Starts

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893593
• Other study ID #: Young Hearts, Strong Starts
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2013
• Last updated: August 13, 2014
• Start date: November 2011
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

Inclusion Criteria:

• Patients seen for well child visits

Exclusion Criteria:

• Terminally ill patients

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Risk Reduction

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Lurie Children's Hospital	Chicago	Illinois
United States	East Carolina University	Greenville	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
RTI International	Ann & Robert H Lurie Children's Hospital of Chicago, East Carolina University, Pediatric Practice Research Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year	No
Secondary	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.	One year	No