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Young Hearts, Strong Starts

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ClinicalTrials.gov Identifier: NCT01893593
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : August 15, 2014
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

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.


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Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : October 2013

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients seen for well child visits

Exclusion Criteria:

  • Terminally ill patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893593


Locations
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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
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Principal Investigator: Ken LaBresh, MD RTI International