Trial record 2 of 54 for:    Young and Strong

Young Hearts, Strong Starts

This study has been completed.
Sponsor:
Collaborators:
East Carolina University
Pediatric Practice Research Group
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01893593
First received: June 27, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Cardiovascular Risk Reduction
Other: Intervention
Other: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
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

Further study details as provided by RTI International:

Primary Outcome Measures:
  • Summary composite measure of practice performance and exposure [ Time Frame: One year ] [ Designated as safety issue: No ]
    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:
  • Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Usual care
Other: Control
Guideline summary and data feedback from a baseline medical record review
Active Comparator: Intervention
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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients seen for well child visits

Exclusion Criteria:

  • Terminally ill patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01893593

Locations
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27858
Sponsors and Collaborators
RTI International
East Carolina University
Pediatric Practice Research Group
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Ken LaBresh, MD RTI International
  More Information

No publications provided by RTI International

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01893593     History of Changes
Other Study ID Numbers: Young Hearts, Strong Starts
Study First Received: June 27, 2013
Last Updated: December 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by RTI International:
Cardiovascular risk
lifestyle change
blood pressure
body mass index
tobacco

ClinicalTrials.gov processed this record on April 22, 2014