Young Hearts, Strong Starts

August 13, 2014 updated by: RTI International

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Lurie Children's Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients seen for well child visits

Exclusion Criteria:

  • Terminally ill patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

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

Investigators

  • Principal Investigator: Ken LaBresh, MD, RTI International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 27, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 9, 2013

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Young Hearts, Strong Starts

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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