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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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Lurie Children's Hospital
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North Carolina
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Greenville, North Carolina, Verenigde Staten, 27858
- East Carolina University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients seen for well child visits
Exclusion Criteria:
- Terminally ill patients
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Ander: Controle
Gebruikelijke zorg
|
Guideline summary and data feedback from a baseline medical record review
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|
Actieve vergelijker: Intervention
Multifaceted intervention to improve clinical systems
|
Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Summary composite measure of practice performance and exposure
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Measures of guideline adherence for BMI, blood pressure, and tobacco use and exposure
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ken LaBresh, MD, RTI International
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Young Hearts, Strong Starts
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