Young Hearts, Strong Starts
A Cluster Randomized Trial of the Implementation of the NHLBI Expert Panel Integrated Guidelines for Cardiovascular Health and Risk Reduction in Children and Adolescents
1 other identifier
interventional
32
1 country
2
Brief Summary
This is a cluster randomized trial of pediatric cardiovascular risk reduction guideline implementation in 32 clinical practices
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Nov 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedAugust 15, 2014
August 1, 2014
1.1 years
June 27, 2013
August 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summary composite measure of practice performance and exposure
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 Outcomes (1)
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
One year
Study Arms (2)
Control
OTHERUsual care
Intervention
ACTIVE COMPARATORMultifaceted intervention to improve clinical systems
Interventions
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
Eligibility Criteria
You may qualify if:
- Patients seen for well child visits
You may not qualify if:
- Terminally ill patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RTI Internationallead
- East Carolina Universitycollaborator
- Pediatric Practice Research Groupcollaborator
- Ann & Robert H Lurie Children's Hospital of Chicagocollaborator
Study Sites (2)
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
East Carolina University
Greenville, North Carolina, 27858, United States
Related Publications (2)
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.
PMID: 25157013DERIVEDLaBresh 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.
PMID: 24295879DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ken LaBresh, MD
RTI International
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 9, 2013
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
October 1, 2013
Last Updated
August 15, 2014
Record last verified: 2014-08