Clinical trial NCT01893593: Young Hearts, Strong Starts
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Risk Reduction
Keywords: Cardiovascular risk
lifestyle change
blood pressure
body mass index
tobacco
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: East Carolina University
name: Pediatric Practice Research Group
name: Ann & Robert H Lurie Children's Hospital of Chicago
First posted: 2013-07-09
Enrollment: 32
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 criteria: Inclusion Criteria:

* Patients seen for well child visits

Exclusion Criteria:

* Terminally ill patients

Primary outcomes:
measure: Summary composite measure of practice performance and exposure
timeFrame: One year
Secondary outcomes:
measure: Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
timeFrame: One year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: RTI International
name: Ken LaBresh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LaBresh KA, Ariza AJ, Lazorick S, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Salinas IG, Bender RH, Binns HJ. Adoption of cardiovascular risk reduction guidelines: a cluster-randomized trial. Pediatrics. 2014 Sep;134(3):e732-8. doi: 10.1542/peds.2014-0876.
citation: LaBresh KA, Lazorick S, Ariza AJ, Furberg RD, Whetstone L, Hobbs C, de Jesus J, Bender RH, Salinas IG, Binns HJ. Implementation of the NHLBI integrated guidelines for cardiovascular health and risk reduction in children and adolescents: rationale and study design for young hearts, strong starts, a cluster-randomized trial targeting body mass index, blood pressure, and tobacco. Contemp Clin Trials. 2014 Jan;37(1):98-105. doi: 10.1016/j.cct.2013.11.011. Epub 2013 Dec 1.