Young Hearts, Strong Starts

Sponsor

RTI International (Other)

Overall Status

Completed

CT.gov ID

NCT01893593

Collaborator

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

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Risk Reduction	Other: Intervention Other: Control	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients seen for well child visits

Exclusion Criteria:

Terminally ill patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lurie Children's Hospital	Chicago	Illinois	United States	60611
2	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RTI International

ClinicalTrials.gov Identifier:

NCT01893593

Other Study ID Numbers:

Young Hearts, Strong Starts

First Posted:

Jul 9, 2013

Last Update Posted:

Aug 15, 2014

Last Verified:

Aug 1, 2014

Keywords provided by RTI International

Study Results

No Results Posted as of Aug 15, 2014